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RCT
ACE Report #3126

THA: No benefit of high-volume ropivacaine infiltration to multimodal oral analgesia


Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A

High-volume infiltration analgesia in bilateral hip arthroplasty: A randomized, double-blind placebo-controlled trial

Acta Orthop. 2011 Aug;82(4):423-6. Epub 2011 Jul 13

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Synopsis

12 patients undergoing bilateral total hip arthroplasty (THA) were randomized to receive a high-volume infiltration of analgesia, administered intraoperatively to one hip, and a placebo saline solution to the other hip. Patients also received a pre-operative oral multimodal analgesic regimen. The primary outcome was postoperative pain. Results indicated that the high-volume analgesic intervention may not produce a clinically relevant analgesic effect post-operatively in patients undergoing bilateral THA compared to the saline group. These results indicate that a pre-operative oral multimodal analgesic regimen may provide sufficient pain relief for THA.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Lundbeck Foundation and IMK Almene Fond, Copenhagen, Denmark
Conflicts:
None disclosed

Risk of Bias

8.5/10

Reporting Criteria

16/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Randomization

3/4

Outcome Measurements

2/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Local analgesia (intraoperative infiltration) has been reported to be effective in total knee arthroplasty, but there are limited studies and data regarding total hip arthroplasty trials. Postoperative pain after hip arthroplasty may be effectively managed with high-volume analgesia infiltration. Previous studies have examined this hypothesis, but there is uncertainty regarding the results due to methodological limitations. This double-blind placebo-controlled study examines the outcomes with high-volume analgesia infiltration compared to a placebo in bilateral hip arthroplasty.

What was the principal research question?

What are the outcomes in postoperative pain when patients undergoing bilateral total hip arthroplasty (THA) receive a high-volume infiltration of analgesia (170 mL ropivacaine 0.2% with epinephrine at 1:100,000) with supplementary injections postoperatively, compared to a saline placebo when examined over the course of the first 48 hours postoperatively?

Study Characteristics -
Population:
12 patients undergoing bilateral total hip arthroplasty (THA) (Mean age: 60 (41-82) years)
Intervention:
High-volume (170 mL) ropivacaine (0.2%) with epinephrine (1:100,000), administered intra-operatively on one hip. Supplementary injections were also administered through an intra-articular epidural catheter postoperatively (n=12; first hip). Oral analgesia (multimodal regimen of gabapentin, celecoxib, and acetaminophen) was given pre-operatively.
Comparison:
Placebo: 170 mL 0.9% saline infiltration on the other hip (n=12; second hip). Oral analgesia (multimodal regimen of gabapentin, celecoxib, and acetaminophen) was given pre-operatively.
Outcomes:
Pain at each hip postoperatively at rest and with 45 degrees hip flexion. (Visual Analog Scale), length of hospital stay, and amount of morphine delivered.
Methods:
RCT: Double-blind; Placebo-controlled
Time:
48 hours (Assessment at 4, 8, 9, 24, 24.5, 25, 26, 32, and 48 hours postoperatively)

What were the important findings?

  • Patients reported similar VAS score for the intervention hip (ropivacaine and epinephrine) and the placebo hip (saline) at rest and at 45 deg hip flexion (p>0.05)
  • Significantly less pain was reported in the saline placebo hip at rest, 32 hr postoperatively (p=0.03)
  • The median hospital stay between the two groups was 7 days (Range: 2-7 days), and the mean duration of surgery was 178 (range 76-325) minutes.
  • At 4, 8, 24, 32, and 48 h postoperatively, patients received a morphine administration of 6.5 (4-12) mg, 14 (11-26) mg, 32 (17-53) mg, 36 (19-61) mg, and 43 (20-70) mg, respectively.
  • No complications requiring intervention were reported during the study period.

What should I remember most?

Patients in both the intervention (Ropivacaine) and placebo (saline) group had comparably low pain scores. An intraarticular high-volume (170 mL) ropivacaine (0.2%) with epinephrine (1:100,000) treatment, followed by repeated postoperative injections, may not result in clinically effective analgesia effect in patients undergoing total hip arthroplasty, when combined with a multimodal oral analgesia taken pre-operatively.

How will this affect the care of my patients?

Patients receiving a high-volume intraoperative injection of ropivacaine 0.2% perioperatively, followed by repeated postoperative injections, may not find any clinically relevant analgesic effect when treatment is combined with mutimodal oral analgesic regimen taken pre-operatively.

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