Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy

Post-operative Pain Clinical Trial

Official title:

A Randomized Controlled Trial (RCT) Comparing Presacral Nerve Block Versus Sham Block on Post-operative Pain in Women Undergoing Total Laparoscopic Hysterectomy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953766
• Other study ID #: REB# 21-0104-A
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2, 2023
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Mara Sobel, MD
• Phone: 416 586 8273
• Email: mara.sobel[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.

Description:

The proposed study is a single-center parallel group RCT comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block). This drug/dose was selected based on the recent study by Rapp et al. who instilled 20mL of ropivacaine into the presacral nerve at the time of open hysterectomy. Participants will be selected using a convenience sample from Mount Sinai Hospital's outpatient gynecology clinics. All patients > or = age 18 years undergoing total laparoscopic hysterectomy will be considered for this study. Exclusion criteria include: previous presacral neurectomy, concurrent surgical procedure other than salpingectomy and/or oophorectomy, gynecological cancer beyond stage 1 disease, chronic opioid consumption, fibromyalgia, BMI >50, language barrier, inability to communicate and inability to provide consent. All potentially eligible patients will be invited to participate in this study by their surgeon. Interested patients will then meet with a member of the research team to explain the study and obtain consent.

The investigators will create a randomization list using a computer-generated allocation sequence in equal ratio with study numbers 1 to 60. Our clinic nurse, who works 5 days per week in our ambulatory office and who will have no other role in this study, will prepare the active and placebo syringes and label the syringes according to the randomization list. Each syringe will be prepared individually and provided to the surgeon on the day of surgery.

Study participants will be randomized on the day of surgery. The surgeon will instill the drug/placebo from the labeled syringe into the presacral space as the first step prior to starting the hysterectomy.

The surgeon, research team, participants and data analysts will be blinded to treatment group.

Each study patient will receive standardized perioperative care as follows:

All patients will receive preoperative multimodal analgesia with acetaminophen 1000 mg.

A protocolized general anesthetic will be used for all patients. Induction of anesthesia will be performed with fentanyl (1-3 mcg/kg), propofol (2-3 mg/kg), and rocuronium (0.6 mg/kg), followed by endotracheal intubation. Patients will be maintained with Sevoflurane anesthetic titrated to a minimum alveolar concentration (MAC) of 0.9-1.2 in a mixture of 50:50 air/oxygen. Analgesia will be provided with intravenous fentanyl and/or hydromorphone administered to maintain mean arterial pressure or heart rate within 20% of baseline measurements. At skin closure, unless contraindicated, all patients will be administered intravenously ondansetron 4 mg and IV dexamethasone 0.1 mg/kg for nausea prophylaxis. Unless contraindicated, all patients will also receive intravenous ketorolac 30 mg for analgesia. Local anesthetic will be provided at the site of the port incisions (2ml per port site of 0.25% bupivacaine with epinephrine). Following completion of surgery, neuromuscular blockade will be antagonized with neostigmine and glycopyrrolate, and patients will be extubated and brought to the post anesthesia care unit (PACU). As per protocol and routine care, the only adjunctive analgesic administered intra-operatively in addition to opioids will be intravenous ketorolac.

Post-operative pain scores will be assessed using a self-administered numeric rating scale (NRS) for pain at 1, 2 and 3 hours after arrival in the PACU. Those patients with pain scores > 4/10 will receive analgesia according to a standard postoperative analgesic regimen. This will consist of intravenous fentanyl 25-50 mcg boluses every 5-10 minutes, intravenous administration of hydromorphone 0.2-0.4 mg boluses as required, and oral administration of either hydromorphone IR 1-2 mg or oxycodone IR 5-10 mg.

Rescue antiemetics will be administered if required at the discretion of the anesthesiologist in the form of IV metoclopramide 5-10 mg, ondansetron 4 mg, or dimenhydrinate 25-50 mg.

Patients will be contacted post-operatively days 1, 2 and 7 in order to assess post-operative pain scores, calculate total opioid consumption and elicit any adverse events (secondary outcomes).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Undergoing total laparoscopic hysterectomy

Exclusion Criteria:

• Previous presacral neurectomy

• Concurrent surgical procedure other than salpingectomy and/or oophorectomy

• Gynecological cancer beyond stage 1 disease

• BMI > 50

• Chronic opioid consumption

• Fibromyalgia

• Language barrier

• Inability to communicate and provide consent

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Ropivacaine injection
Presacral nerve block using 20mL of local ropivacaine 5.0mg/ml
• Normal saline injection
Sham block using 20 mL of normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative narcotic usage	Total narcotics administered from end of surgery until post-operative days 1, 2 and 7 (calculated from the hospital medical records and pill counts from discharge medications to be elicited by phone the day after surgery)	Post-operative days 1, 2 and 7
Other	Adverse effects/complication rates	Any negative outcome that is self-reported and elicited from a telephone survey	Post-operative days 1, 2 and 7
Primary	Early post-operative pain at 3 hours following surgery	Early post-operative pain measured at 3-hours following surgery by a self-administered numeric pain rating scale (NRS) on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable	3 hours following surgery
Secondary	Post-operative pain at other time points	Delayed post-operative pain measured by NRS scores at 1 hour, 2 hour, and post-operative days 1, 2 and 7 on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable	1 hour, 2 hour, and post-operative days 1, 2 and 7