Clinical Question: Is patient controlled anesthesia (PCA) as effective as PRN IM pain medication in treating post-op total hip replacement patients?

PICO Question: In adults undergoing total hip replacements, is patient controlled analgesia (PCA) as effective as IM pain medications for reduction of postoperative pain?

Search Strategy:

Pubmed 

• (injections) AND ((patient controlled anesthesia) AND (total hip replacement))→ 135 articles 
• (injections) AND ((patient controlled anesthesia) AND (total hip replacement)) / limits: 10 years → 55 articles
• (injections) AND ((patient controlled anesthesia) AND (total hip replacement)) / limits: 10 years, clinical trials → 42 articles

Cochrane 

• post op pain patient controlled anesthesia → 33 results 

CUNY Library OneSearch: 

• “PCA, postop, pain” → 13 results
• “PCA, postop, pain”/ limits: 5 years → 4 results
• “Hip replacement, postop, pain” → 20 results

Articles Chosen:

Articles chosen based on the date of publication, level of evidence, population examined, and primary outcomes.

Pubmed → 3

Cochrane → 1

CUNY Library OneSearch → 1

PICO Search Terms

P	I	C	O
adults	PCA	Injections	Reduction of post-operative pain
elderly	Patient controlled	As needed	Pain relief
Post op patients	analgesia	intermittent

Articles Chosen for Inclusion:

ARTICLE #1: 

Citation: McNicol, E. D., Ferguson, M. C., & Hudcova, J. (2015). Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain. The Cochrane database of systematic reviews, 2015(6), CD003348. https://doi.org/10.1002/14651858.CD003348.pub3

Abstract

Background: This is an updated version of the original Cochrane review published in Issue 4, 2006. Patients may control postoperative pain by self administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne et al found a strong patient preference for PCA over non-patient controlled analgesia, but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne’s meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, a 2001 review by Walder et al did not find statistically significant differences in pain intensity or pain relief between PCA and groups treated with non-patient controlled analgesia.

Objectives: To evaluate the efficacy and safety of patient controlled intravenous opioid analgesia (termed PCA in this review) versus non-patient controlled opioid analgesia of as-needed opioid analgesia for postoperative pain relief.

Search methods: We ran the search for the previous review in November 2004. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 12), MEDLINE (1966 to 28 January 2015), and EMBASE (1980 to 28 January 2015) for randomized controlled trials (RCTs) in any language, and reference lists of reviews and retrieved articles.

Selection criteria: We selected RCTs that assessed pain intensity as a primary or secondary outcome. These studies compared PCA without a continuous background infusion with non-patient controlled opioid analgesic regimens. We excluded studies that explicitly stated they involved patients with chronic pain.

Data collection and analysis: Two review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence. We performed meta-analysis of outcomes that included pain intensity assessed by a 0 to 100 visual analog scale (VAS), opioid consumption, patient satisfaction, length of stay, and adverse events.

Main results: Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay.

Authors’ conclusions: Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control.

ARTICLE #2: 

Citation: Nasersarrafan, Kavehbehaeen, Sholehnesioonpour, T. Ghalami, M. Soltanzadeh (2014). Comparison Intravenous Patient-Controlled Analgesia (PCA) with (Paracetamol + Morphine) and (Paracetamol + Tramadol) For Earlier Hip Joint Movement and Satisfaction in Orthopedic Surgeries. International Journal of Current Research in Chemistry and Pharmaceutical Sciences, 1(6), 136–139. https://citeseerx.ist.psu.edu/doc_view/pid/3d45a6f8aa7253dc96e56e671c960305f155f1d4#citations

Abstract: In this study we evaluated effectiveness of post-operative pain management with Intravenous patient-controlled analgesia (PCA) device with combination of paracetamol and opioids drugs for earlier joint movement satisfaction and wellbeing of orthopedic patient with femoral intertrochanteric and neck fracture.Thirty-six patients were randomized in three groups: group C (Control group) only received routine pain control approach in orthopedic ward with intramuscular NSAID drugs(Diclofenac 100mg), group M (Paracetamol 2g +Morphine sulfate 10mg) ,and T(Paracetamol 2gr + Tramadol 100 mg)received intravascular analgesic with patient control analgesia (PCA) with two different combination. The mean time for joint movement and come back to previous ordinary activity after surgery were in group C 30±6.2 hour, in group M (Paracetamol 2g +Morphine sulfate 10mg) 24±3.50 hours, and in group T(Paracetamol 2gr + Tramadol 100 mg) 24±3.00 hours. It seems patient controlled analgesia PCA with Paracetamol + Morphine or Tramadol can be useful for pain management and early hip joint movement after orthopedic surgeries.

ARTICLE # 3:

Citation: Kurtović, B., Rotim, K., Sajko, T., Rotim, C., Friganović, A., & Milošević, M. (2022). Intermittent tramadol vs tramadol administration via patient-controlled pump after lumbar discectomy: a randomized controlled trial. Croatian medical journal, 63(2), 110–116. https://doi.org/10.3325/cmj.2022.63.110

Abstract

Aim: To compare the effect of intermittent tramadol dosing vs tramadol administration via patient-controlled pump on pain after lumbar discectomy.

Methods: This randomized prospective study enrolled 100 patients who underwent elective LIV-LV lumbar discectomy in the neurosurgery department at Sestre Milosrdnice University Hospital Center from May 2016 to July 2017. Patients were randomized to receive either tramadol (600 mg daily) via a patient-controlled analgesia (PCA) pump or intermittently. Pain was evaluated by the Croatian version of Short-Form McGill Pain Questionnaire.

Results: Forty percent of patients were women. The median (interquartile range) age of the patients was 51 (40-61) years. The groups did not differ in pain at 7 pm on the day of discectomy. However, in the morning and evening on the first postoperative day and in the morning and evening of the second postoperative day, the PCA group had significantly lower pain (P = 0.023, P < 0.001, P < 0.001, P = 0.026, respectively).

Article #4: 

Citation: Keïta, H., Geachan, N., Dahmani, S., Couderc, E., Armand, C., Quazza, M., Mantz, J., & Desmonts, J. M. (2003). Comparison between patient-controlled analgesia and subcutaneous morphine in elderly patients after total hip replacement †. British Journal of Anaesthesia, 90(1), 53–57. https://doi.org/10.1093/bja/aeg019

Abstract

Background: The goal of this study was to evaluate the effectiveness on postoperative pain, and cognitive impact, of patient-controlled analgesia (PCA) compared with subcutaneous (s.c.) injections of morphine in elderly patients undergoing total hip replacement (THR).

Methods: Forty patients older than 70 yr were randomly assigned to two different postoperative analgesic techniques for 48 h: i.v. PCA morphine (dose, 1 mg; lockout interval, 8 min; PCA group) or regular s.c. morphine injections (SC group). Postoperative pain was assessed at rest and when moving, using a visual analogue scale (VAS) every 4 h. A Mini Mental Status (MMS) examination was used to assess cognitive functions before surgery, at 2 h, 24 h and 48 h after surgery, and at hospital discharge. Side-effects were also recorded systematically during the first 48 h after surgery.

Results: The PCA group showed significantly lower pain scores than the SC group both at rest and during mobilization. However, the clinical significance of pain scores was weak. There was no intergroup difference in postoperative MMS scores. The incidence of side-effects was similar in both groups.

Conclusions: We conclude that in healthy elderly subjects undergoing THR, the flexibility of the analgesic regimen is more important than the route of administration with regard to efficacy, adverse effects and recovery of cognitive function.

ARTICLE #5:

Citation: Walder, B., Schafer, M., Henzi, I. and Tramèr, M.R. (2001), Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. Acta Anaesthesiologica Scandinavica, 45: 795-804. https://doi.org/10.1034/j.1399-6576.2001.045007795.x

Background: 

The usefulness of intravenous patient-controlled analgesia (PCA) with opioids for postoperative analgesia is not well defined.

Methods: We systematically searched (MEDLINE, EMBASE, Cochrane Library, bibliographies, any language, to January 2000) for randomised trials comparing opioid-based PCA with the same opioid given intramuscularly, intravenously, or subcutaneously. Weighted mean differences (WMD) for continuous data, relative risks (RR) and numbers-needed-to-treat (NNT) for dichotomous data were calculated with 95% confidence intervals (CI) using fixed and random effects models.

Results: 

Data from 32 trials were analysed: 22 (1139 patients) were with morphine, five (682) with pethidine, three (184) with piritramide, one (47) with nalbuphine and one (20) with tramadol. In three morphine and one pethidine trial (352 patients), more patients preferred PCA (89.7% vs 65.8%, RR 1.41 (95%CI 1.11 to 1.80), NNT 4.2). Combined dichotomous data on pain intensity and relief, and the need for rescue analgesics from eight morphine, one pethidine, one piritramide, and one nalbuphine trial (691 patients), were in favour of PCA (RR 1.22 (1.00 to 1.50), NNT 8). In two morphine trials (152), pulmonary complications were more frequently prevented with PCA (100% vs 93.3%, RR 1.07 (1.01 to 1.14), NNT 15). There was equivalence for cumulative opioid consumption, pain scores, duration of hospital stay, and opioid-related adverse effects.

Conclusion: These trials provide some evidence that in the postoperative pain setting, PCA with opioids, compared with conventional opioid treatment, improve analgesia and decrease the risk of pulmonary complications, and that patients prefer them.

Summary of the Evidence:

Author (Date)	Level of Evidence	Sample/Setting (# of subjects/ studies, cohort definition etc. )	Outcome(s) studied	Key Findings	Limitations and Biases
Ewan D McNicol, McKenzie C Ferguson, Jana Hudcova (2015)	Level 1- Systematic Review	Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group	Primary: –pain intensity assessed by a 0 to 100 visual analog scale (VAS) Secondary: -opioid consumption -patient satisfaction -length of stay -adverse events	Primary Participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals Scores over 0 to 24 hours were nine points lower (95% confidence interval (CI), moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12, low quality evidence).  Our meta-analysis provides moderate to very low quality evidence that PCA provides superior analgesia in comparison to non-patient controlled regimens Secondary: participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (95% CI). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay.	All studies involved had  a high risk of performance bias in that none of them were blinded The authors did not assess publication bias The authors excluded any study that included participants who had chronic pain (which may inappropriately affect orthopedic patients) Articles used for analysis were published between 1982 and 2014
Nasersarrafan, Kavehbehaeen, Sholehnesioonpour, T. Ghalami, M. Soltanzadeh (2014)	Level 2- RCT	36 patients were divided randomly into 3 groups = control (group C), paracetamol with Tramadol (group T), paracetamol with Morphine (group M).	According to visual analogue scale (VAS) pain was measured from zero (no pain) to ten (worst pain that patients could not tolerate). Patients pain measured 48 hours after operations and also evaluated for tolerate early hip joint movement time. Data was analyzed by SPSS static software (version 11.5). The time of joint movement data were expressed as mean ± standard deviation for quantitative variables by student t-test and chi- squared test were compared the parametric patient, with P-values < 0.05 statistically significant.	Visual analogue scale/mean post-operative pain perception: no significance between PCA groups but significance when compared to control. Mean time of early hip joint movement that patients could tolerate after operation: no significance between PCA groups but significance when compared to control (significantly higher in control group). Post-op time back to ordinary activity: no significance between PCA groups but significance when compared to control. The study suggests use of patient controlled analgesia (PCA) lead to better post-op pain control and patient satisfaction, early hip joint movement and reduce time of back the patient to ordinary activity after surgery.	The sample size is very small; 36 patients are involved in the study.
Kurtović, B., Rotim, K., Sajko, T., Rotim, C., Friganović, A., & Milošević, M. (2022)	Level 2- RCT	This randomized prospective study enrolled 100 patients who underwent elective LIV-LV lumbar discectomy in the neurosurgery department at Sestre Milosrdnice University Hospital Center from May 2016 to July 2017	Pain levels measured by patient perception surveys on days 0, 1, and 2 post op.	The groups did not differ in pain at 7 pm on the day of discectomy. However, in the morning and evening on the first postoperative day and in the morning and evening of the second postoperative day, the PCA group had significantly lower pain. (P = 0.023, P < 0.001, P < 0.001, P = 0.026, respectively)	This study is limited by a lack of data collection on side effects of tramadol administration. Furthermore, we did not collect the data on the number of patients per group who were excluded due to repetitive side effects after administering metoclopramide and/or thiethylperazine therapy.
Keïta, H., Geachan, N., Dahmani, S., Couderc, E., Armand, C., Quazza, M., Mantz, J., & Desmonts, J. M. (2003)	Level 2- RCT	This is a randomized clinical trial with 40 patients older than 70 years old to determine the effectiveness of PCA morphine or regular SC morphine injections to manage post-operative pain and cognitive impact after they underwent total hip replacements.	-pain scores at rest and mobilization – incidence of side effects – postop MMS scores for cognitive function -duration of hospital stay	The PCA group showed significantly lower pain scores than the SC group both at rest and during mobilization. However, the clinical significance of pain scores was weak → healthy elderly subjects undergoing THR, the flexibility of the analgesic regimen is more important than the route of administration with regard to efficacy, adverse effects and recovery of cognitive function.	This study is limited because it cannot achieve true double blind due to the conditions of the study. Patients were aware of which treatment they received because they were given instructions to operate PCA/manage their pain post-surgery. In addition, this article had a relatively small sample size at 40 patients which could have limited the significance of the results.
Walder, B., Schafer, M., Henzi, I. and Tramèr, M.R. (2001)	Level 1 – Systematic Review	32 trials were analyzed: 22 (1139 patients) were with morphine, five (682) with pethidine, three (184) with piritramide, one (47) with nalbuphine and one (20) with tramadol	-Pain intensity  -Opioid consumption   -Opioid related  adverse  effects -Patient Satisfaction -Patient preference   -Post-op pulmonary complications  -Cost-effectiveness	-There is evidence that PCA with opioids is slightly more analgesic than conventional opioid analgesia -The amount of opioids consumed is no different with the two methods -The incidence of opioid-related adverse reactions is similar.  -There is evidence that patients prefer PCA, although they are not necessarily more satisfied -There is some evidence that there are fewer postoperative pulmonary complications with PCA compared with conventional opioid analgesia -There is a lack of valid data on cost-effectiveness with these devices.	-There is no evidence of any difference in the length of hospital stay -Patients seem to prefer the devices, but we do not know why they prefer them -The result of decreased risk of pulmonary complications with PCA was statistically significant, but based on a low number of patients  -Many trials were of limited size (more than 50 participants in only 4 trials)  -No studies were properly blinded (although blinding is difficult in this setting), but the lack of blinding leaves all the trials open to the criticism of observer bias

Conclusion(s):

Article #1: Our meta-analysis provides moderate to very low quality evidence that PCA provides superior analgesia in comparison to non-patient controlled regimens. Participants were more satisfied with PCA and consumed higher amounts of opioids than controls. Those receiving PCA had a higher incidence of pruritus but had a similar incidence of other adverse events. There was no difference in the length of hospital stay.

Article #2: The study suggests use of patient controlled analgesia (PCA) lead to better post-op pain control and patient satisfaction, early hip joint movement and reduce time of back the patient to ordinary activity after surgery. However, the study has a small sample size of 36, therefore we need to take that into account.

Article #3 Results: Forty percent of patients were women. The median (interquartile range) age of the patients was 51 (40-61) years. The groups did not differ in pain at 7 pm on the day of discectomy. However, in the morning and evening on the first postoperative day and in the morning and evening of the second postoperative day, the PCA group had significantly lower pain (P = 0.023, P < 0.001, P < 0.001, P = 0.026, respectively). → PCA group better in POD 1+ (no difference on same day pain)

Article 4: The PCA group showed significantly lower pain scores than the SC group both at rest and during mobilization. However, the clinical significance of pain scores was weak. There was no intergroup difference in postoperative MMS scores. The incidence of side-effects was similar in both groups → We conclude that in healthy elderly subjects undergoing THR, the flexibility of the analgesic regimen is more important than the route of administration with regard to efficacy, adverse effects and recovery of cognitive function

Article 5: There are four major findings of this systematic review. First, there is evidence that PCA with opioids is slightly more analgesic than conventional opioid analgesia, that the amount of opioids consumed is no different with the two methods, and that the incidence of opioid-related adverse reactions is similar. Second, there is evidence that patients prefer PCA, although they are not necessarily more satisfied. Third, based on a limited number of data, there is some evidence that there are fewer postoperative pulmonary complications with PCA compared with conventional opioid analgesia. And finally, there is a lack of valid data on cost-effectiveness with these devices.

 Clinical Bottom Line:

PCA offers superior analgesia vs PRN IM pain medication; however, this recommendation is not strongly supported so patient demographics should be considered when determining which method to use. Not all studies focused specifically on hip replacements so our conclusion is based on extrapolating data.