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The Effect of Gabapentin on Post-Operative Pain in Minimally Invasive Sacrocolpopexy: A Randomized Controlled Pilot Study

Fellow: Josephine Doo, MD (Urogynecology and Reconstructive Pelvic Surgery)

Faculty Advisor: Lieschen Quiroz, MD

Background

Enhanced recovery after surgery (ERAS) has been synonymous with increasing non-opioid multimodal therapies and decreasing opioid therapies after surgery to improve perioperative care.  The ultimate goal is to decrease narcotic usage and hospital stays, while improving pain control and regaining baseline functional status.  ERAS protocols include, but are not limited to, patient education, patient optimization prior to admission, timing of oral intake of fluids and solids, nausea/vomiting prophylaxis, multimodal analgesia, and day of surgery ambulation.  With the emergence of multimodal therapy, multiple randomized control trials have suggested perioperative gabapentin as a benefit for abdominal and vaginal hysterectomies alone. Limited data is known about the specifics of routine adjuvant post-operative gabapentin in the realm of urogynecology.  The primary aim of this study is to examine the efficacy of gabapentin in decreasing postoperative pain scores in the immediate 2 weeks following minimally invasive sacrocolpopexy (MISC) surgery. Secondary aims include measuring post-operative opioid consumption, patient degree of bother of pelvic floor symptoms, and incidence of side effects.

Methods

This was a single-site randomized control study of English-speaking adult women undergoing MISC for pelvic organ prolapse. Exclusions include concurrent sphincter or fistula repair, urethral diverticulectomy or mesh excision, current gabapentin or pregabalin use, oxygen dependency, cognitive impairment by Mini Cog score < 3, and glomerular filtration rate of < 30mL/min. Groups were randomized to standard ERAS protocol post-operative care with placebo versus study group of scheduled postoperative gabapentin plus ERAS protocol for the first two weeks following surgery. The primary outcome is the change in pain during normal activity and at rest by the validated surgical pain scale (SPS) on 2-week post-operative visit from baseline scores. Secondary outcome measures included average morphine milligram equivalent (MME), validated surveys including pelvic floor distress inventory (PFDI-20) and pelvic floor impact questionnaire (PFIQ-7), and side effect incidence. Baseline and demographics data were analyzed using Student’s t-test for continuous variables and Fisher’s exact or χ2 tests for categorical variables. Our outcomes were evaluated with Student’s t-test, Wilcoxon rank sum, and χ2 tests when appropriate.

Results

Over 100 patients were screened and 32 participants (16 placebo group, 16 gabapentin group) were enrolled. Demographics including age, parity, Charlson Comorbidity Index, prior abdominal surgeries, prolapse stage, and baseline rate of bother by validated PFDI-20 and PFIQ-7 surveys did not differ by treatment group. The median change in SPS score from pre-operative baseline scores and 2-week post-operative scores in the placebo and gabapentin treatment groups at rest were 0 (-0.5, -1.0) vs 0 (-1.0, 1.0), p = 0.88, respectively; during normal activity was 0 (-1.5, 1.0) vs 0 (-1.0, 0.5), p = 0.60 respectively; and worst pain 0 (-3.0, 2.5) vs 0 (-1.5, 1.0), p = 0.94 respectively. Incidentally, there was a higher incidence for nausea, vomiting, and diarrhea side effects in the placebo group (20%) vs gabapentin group (0%), p=0.07. Median MME usage per day was 4.3 vs 1.7 in placebo vs gabapentin treatment group respectively, p = 0.14. Validated questionnaires showed overall statistically significant improvement in pelvic floor symptoms in both groups.

Conclusions

When adding scheduled post-operative gabapentin in MISC surgery, two-week pain scores did not change significantly when compared to placebo. Although not statistically significant, there appeared to be trend that adjuvant gabapentin had a protective effect against developing post-operative nausea, vomiting, and diarrhea. There also seemed to be trend of less overall morphine milligram equivalent (MME) usage in the gabapentin group vs placebo group too, though again not statistically significant.