Meeting Paper
SGS Papers
Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial

Presented at the Society of Gynecologic Surgeons 45th annual scientific meeting, Tucson, AZ, March 31 through April 3, 2019.
https://doi.org/10.1016/j.ajog.2019.06.002Get rights and content

Background

Postoperative pain control after urogynecological surgery has traditionally been opioid centered with frequent narcotic administration. Few studies have addressed optimal pain control strategies for vaginal pelvic reconstructive surgery that limit opioid use.

Objective

The objective of the study was to determine whether, ice packs, Tylenol, and Toradol, a novel opioid-sparing multimodal postoperative pain regimen has improved pain control compared with the standard postoperative pain regimen in patients undergoing inpatient vaginal pelvic reconstructive surgery.

Study Design

This was a multicenter randomized controlled trial of women undergoing vaginal pelvic reconstructive surgery. Patients were randomized to the ice packs, Tylenol, and Toradol postoperative pain regimen or the standard regimen. The ice packs, Tylenol, and Toradol regimen consists of around-the-clock ice packs, around-the-clock oral acetaminophen, around-the-clock intravenous ketorolac, and intravenous hydromorphone for breakthrough pain. The standard regimen consists of as-needed ibuprofen, as-needed acetaminophen/oxycodone, and intravenous hydromorphone for breakthrough pain. The primary outcome was postoperative day 1 pain evaluated the morning after surgery using a visual analog scale. Secondary outcomes included the validated Quality of Recovery Questionnaire, satisfaction scores, inpatient narcotic consumption, outpatient pain medication consumption, and visual analog scale scores at other time intervals. In all, 27 patients in each arm were required to detect a mean difference of 25 mm on a 100 mm visual analog scale (90% power).

Results

Thirty patients were randomized to ice packs, Tylenol, and Toradol and 33 to the standard therapy. Patient and surgical demographics were similar. The median morning visual analog scale pain score was lower in the ice packs, Tylenol, and Toradol group (20 mm vs 40 mm, P = .03). Numerical median pain scores were lower at the 96 hour phone call in the ice packs, Tylenol, and Toradol group (2 vs 3, P = .04). Patients randomized to the ICE-T regimen received fewer narcotics (expressed in oral morphine equivalents) from the postanesthesia care unit exit to discharge (2.9 vs 20.4, P < .001) and received fewer narcotics during the entire hospitalization (55.7 vs 91.2, P < .001). At 96 hour follow up, patients in the ice packs, Tylenol, and Toradol group used 4.9 ketorolac tablets compared with 4.6 oxycodone/acetaminophen tablets in the standard group (P = .81); however, ice packs, Tylenol, and Toradol patients required more acetaminophen than ibuprofen by patients in the standard arm (10.7 vs 6.2 tablets, P = .012). There were no differences in Quality of Recovery Questionnaire or satisfaction scores either in the morning after surgery or at 96 hour follow up.

Conclusion

The ice packs, Tylenol, and Toradol multimodal pain regimen offers improved pain control the morning after surgery and 96 hours postoperatively compared with the standard regimen with no differences in patient satisfaction and quality of recovery. Ice packs, Tylenol, and Toradol can significantly limit postoperative inpatient narcotic use and eliminate outpatient narcotic use in patients undergoing vaginal pelvic reconstructive surgery.

Section snippets

Materials and Methods

This was an investigator-initiated, multicenter, randomized controlled clinical trial at 2 tertiary medical centers. This study was registered with ClinicalTrials.gov (ID: NCT03052816) and institutional review board approval was obtained at both sites. Consolidated Standards of Reporting Trials guidelines were adhered to for study reporting.17 All recruited patients were from the Division of FPMRS at the respective institution.

Patients were enrolled in the study if they consented to study

Results

Between April 2017 and April 2018, 138 women who were scheduled for vaginal pelvic reconstructive surgery were assessed for eligibility. Seventy-two patients were excluded; 55 patients did not meet inclusion criteria and 17 patients chose not to participate after the study was explained to them.

Sixty-six patients were randomized to the ICE-T or Standard protocols. Of the 33 patients who were randomized to the ICE-T regimen, 3 were excluded after randomization. One of the excluded patients was

Comment

The current opioid crisis and patterns of postoperative prescription narcotic use in the United States warrant a closer look at postsurgical pain control. Although growing, there is limited prospective data in FPMRS focusing on not only postsurgical pain control requirements but also pain control regimens that would limit narcotic use. The goal of this study was to determine whether the ICE-T postoperative pain control regimen had improved postsurgical pain control, satisfaction, quality of

Acknowledgment

This study was registered at ClinicalTrials.gov with the identifier number NCT03052816.

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  • Cited by (0)

    The authors report no conflict of interest.

    Cite this article as: Petrikovets A, Sheyn D, Sun HH, et al. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol 2019;221:511.e1-10.

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