Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

Summary

Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.

Conditions

• Pain, Postoperative

Interventions

DRUG

Gabapentin

600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op

DRUG

Acetaminophen

Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op

DRUG

Celecoxib

Celecoxib 200mg PO q 12h x 7d post op

DRUG

Ketorolac

30mg IV once at end of hysterectomy procedure

PROCEDURE

Paracervical block with ropivacaine

0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL

PROCEDURE

Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites

0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total

DRUG

Hydromorphone

1mg IV PRN q3h, post op, while inpatient

DRUG

Oxycodone

To be discharged home with: 12 tabs of 5mg PRN q4h

Sponsors & Collaborators

• State University of New York at Buffalo

  lead OTHER

Principal Investigators

• Sarah Andres, D.O. · University at Buffalo

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

25 Years

Max Age

90 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-24

Primary Completion

2022-05-31

Completion

2022-05-31

FDA Drug

Yes

Countries

• United States

Study Locations