SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)

NCT ID: NCT06455540

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nerve block

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

Group Type EXPERIMENTAL

Superior hypogastric plexus block

Intervention Type 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.

Placebo block

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

Group Type PLACEBO_COMPARATOR

Superior hypogastric plexus block

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Nerve block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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E2022273

Identifier Type: -

Identifier Source: org_study_id

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