SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE) (SUBTLE)

Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy

This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Hysterectomy
• Intervention / Treatment: Procedure: Superior hypogastric plexus block

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to provide informed consent
• Undergoing laparoscopic hysterectomy for benign indications

Exclusion Criteria:

• Planned procedure that requires dissection of the presacral space
• Allergy to block medication (s)
• Known or suspected malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo block; The superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline.	Procedure: Superior hypogastric plexus block; Prior to the laparoscopic hysterectomy and any additional procedures, the superior hypogastric plexus block will be performed on all the patients. The block will contain 20 mL of 0.75% ropivacaine hydrochloride or 0.9% normal saline. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.; Other Names: Nerve block
Experimental: Nerve block; The superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride.	Procedure: Superior hypogastric plexus block; Prior to the laparoscopic hysterectomy and any additional procedures, the superior hypogastric plexus block will be performed on all the patients. The block will contain 20 mL of 0.75% ropivacaine hydrochloride or 0.9% normal saline. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.; Other Names: Nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery	The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.	Postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Scores	Pain reported according to a visual rating scale from 0 to 100 points (0= no pain and 100= worst imaginable pain), which details their pain level using Visual Analog Scale (VAS) pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 100, and a higher score indicates greater pain intensity.	Up to postoperative day 2
Postoperative Opioid Use	Postoperative opioid consumption during said time points	Up to postoperative day 2
The Brief Pain Inventory (BPI)	The Brief Pain Inventory (BPI) is a self-administered questionnaire to assess the severity of pain and the impact of pain on the patient's daily functions.	Up to postoperative day 90
The McGill Pain Questionnaire	The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain.	Up to postoperative day 90
Incidence of Adverse events	Incidence of adverse events related to the plexus block (vascular puncture, hematoma, and local anesthetic systemic toxicity (LAST))	Intraoperative (During block performance)
Length of stay in post-anesthesia care unit (PACU) area	Total time in PACU area	Postoperative day 1
Quality of recovery	The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.	Up to postoperative day 2
Postoperative nausea and vomiting	number of participants with nausea or vomiting	Up to postoperative day 2

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): July 16, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Minimally invasive surgery; Quality of recovery; Hysterectomy
• Other Study ID Numbers: E2022273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No