NCT04429022

Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: Female
• Age: 25 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

Material and Methods: This is a prospective cohort study with historical controls. Cases of those receiving a non-opioid multimodal pain regimen will be compared to historical controls of those receiving a traditional opioid pain regimen. All patients undergoing robotic total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy, with a uterine weight ≤325 grams will be included in this study. Multimodal pain regimen will include the following: Protocol: Pre-Op: - Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op area) * Acetaminophen 1000mg PO x1 prior to surgery (in pre-op area) Intra-Op: * Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL * Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL * Will operate at \<15mmHg intra-abdominal pressure with goal of \<12mmHg * At end of procedure during closure of fascia, give 30mg ketorolac IV x 1 Post-Op: * Gabapentin 300mg PO BID for 7 days * Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN * Celecoxib 200mg PO q 12h x 7d * Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 tabs x 5mg upon discharge (90MME) * if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge * Also include standard post-op medications such as zofran, reglan, mylicon… Our primary outcome is opioid pain medication needed after surgery. Our secondary outcomes include pain scores as rated subjectively by the patient, length of stay in hours and whether the patient returns to the clinic or emergency department due to post operative pain within a 2 week period.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-06-11
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study