Available online 25 November 2023

Author links open overlay panel, , , AbstractStudy Objective

To compare postoperative pain and pain-related outcomes following laparoscopic (LS-MISC) versus robotic minimally invasive sacrocolpopexy (R-MISC).

Design

A secondary analysis of an original placebo-controlled randomized-controlled trial (RCT) examining preoperative IV acetaminophen on postoperative pain following MISC.

Setting

Planned secondary analysis of multicenter RCT.

Patients or Participants

Women undergoing MISC.

Interventions

Co-primary outcomes at 24 hours were total opioid use in morphine mg equivalents (MME) and visual analog scale (VAS) pain scores comparing LS-MISC and R-MISC. The secondary outcome was pain scores using a pain diary through seven days post-procedure.

Measurements and Main Results

The original study was a double blind, multi-center, RCT comparing intravenous acetaminophen to placebo that took place between 2014 and 2017. Given that the original trial was unable to show an impact from the use of intravenous acetaminophen, our analysis focused on the impact of surgical modality. We included 90 subjects undergoing MISC: 65 LS-MISC and 25 R-MISC. Most were Caucasian (97.8%) and postmenopausal (88.9%) with mean age 61.2±7.2 years and BMI 27.6±4.4 kg/m2. IV acetaminophen did not impact pain in the original study and was not different between LS-MISC and R-MISC. Concomitant hysterectomy was performed in 67% (LS-MISC) vs. 60% (R-MISC, p=0.49). LS-MISC underwent more perineorrhaphies (15.4% vs 0%, p=0.04) and posterior repairs (18.5% vs 0%, p=0.02). Operative time was longer with LS-MISC (208.5±57.3 vs 143.6±21.0 minutes, p=<0.01). Length of stay was longer with LS-MISC (0.9±0.4 vs 0.7±0.4 days, p=0.02). Women undergoing LS-MISC consumed more opioid MMEs through 24 hours when including intraoperative opioid's (48.5±25.5 vs 35.1±14.6 MME, p=<0.01). Using linear regression correcting for operative time and concomitant vaginal repairs, this difference disappeared. Likewise, when intraoperative opioids were excluded, there was no difference. There were no differences in 24-hour post-operative VAS scores, opioid use in first week, or quality of life (PROMIS PI-SF, all p<0.05).

Conclusion

When comparing VAS pain scores, MME opioid usage, and quality of life between LS-MISC and R-MISC, there was either no difference or differences disappeared after adjusting for confounders. Overall, opioid use, pain scores, and opioid side effects were low.

Section snippetsBackground

Minimally invasive surgery has become the standard treatment for most benign and malignant gynecologic diseases. However, multiple modalities of minimally invasive surgery are now common including traditional laparoscopy, robotic-assisted laparoscopy, vaginal surgery, and vaginal natural orifice laparoscopy. As minimally invasive surgery is now the standard of care for most indications, the focus of research has shifted to which modality is preferred. Currently, the choice has relied on patient

Methods

In the original RCT, subjects undergoing surgery for pelvic organ prolapse (POP) were randomized to receive either intravenous acetaminophen or placebo and the impact on pain scores were assessed. The detailed study design and methods have been previously published 9. All sites received IRB approval, the trial was registered at Clinicaltrials.gov, and patients were recruited from outpatient offices at either the University of Pittsburgh Medical Center or Allegheny Health Network. Women with POP

Results

A total of 90 subjects undergoing minimally invasive sacral colpopexy were included in the analysis, of which 65 underwent LS-MISC, and 25 underwent R-MISC. Overall, the majority of subjects were Caucasian (97.8%) and postmenopausal (88.9%) with a mean age of 61.2±7.2 years and mean body mass index of 27.6±4.4 kg/m2. Concomitant hysterectomy was performed in 59 (65.6%) subjects with no difference between R-MISC and LS-MISC (p=0.49). All hysterectomies were supracervical hysterectomies except

Discussion

The evidence on perioperative pain between robotic assisted laparoscopy and traditional laparoscopy are mixed3-7. The mixed results stem from the difficulty in undertaking a study that looks at pain and pain outcomes as many variables can impact these, including study size and methodology. One non-randomized study from El Hachem et al.6 included 91 patients with Numeric Rating Scale pain that was not different between robotic and laparoscopic surgery. In a similar retrospective, non-randomized

Conclusion

This planned secondary analysis of a randomized controlled trial examining the impact of preoperative IV acetaminophen on postoperative pain did not show a difference in pain scores or opioid use between R-MISC and LS-MISC in the immediate post-operative period and up to one week from surgery. The evidence from this study supports the viewpoint that when choosing a minimally invasive approach, factors other than pain outcomes should be used, as there appears to not be a significant difference

References1

Jenison EL, Gil KM, Lendvay TS, Guy MS. Robotic surgical skills: Acquisition, maintenance, and degradation. Journal of the Society of Laparoendoscopic Surgeons. 2012;16(2):218-228. doi:10.4293/108680812X13427982376185

2

Seamon LG, Cohn DE, Henretta MS, et al. Minimally invasive comprehensive surgical staging for endometrial cancer: Robotics or laparoscopy? Gynecol Oncol. 2009;113(1):36-41. doi:10.1016/j.ygyno.2008.12.005

3

Leitao MM, Malhotra V, Briscoe G, et al. Postoperative pain medication

Declaration of Competing Interest

Jonathan Shepherd disclosed a grant Foundation for Female Health Awareness that was awarded to the departmentc to purchase software to run cost-effectiveness analysis which is related to this work. The remaining authors have nothing to declare and have no conflicts of interest

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© 2023 Published by Elsevier Inc. on behalf of AAGL.