SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)

NCT06455540 | Not Yet Recruiting

• 1 other identifier: E2022273
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hysterectomy

Keywords

Hysterectomy; Minimally invasive surgery; Quality of recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Postoperative Pain Scores

  Up to postoperative day 2

• Postoperative Opioid Use

  Up to postoperative day 2

• The Brief Pain Inventory (BPI)

  Up to postoperative day 90

• The McGill Pain Questionnaire

  Up to postoperative day 90

• Incidence of Adverse events

  Intraoperative (During block performance)

Study Arms (2)

Nerve block

EXPERIMENTAL

The superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride.

Procedure: Superior hypogastric plexus block

Placebo block

PLACEBO COMPARATOR

The superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline.

Procedure: Superior hypogastric plexus block

Interventions

Superior hypogastric plexus block PROCEDURE

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.

Also known as: Nerve block

Nerve block; Placebo block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: July 16, 2024
• Primary Completion: July 15, 2025
• Study Completion: December 31, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share