SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)

N/ANot Yet RecruitingNCT06455540

Sixth Affiliated Hospital, Sun Yat-sen University198 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

198

Conditions

Hysterectomy

Interventions

Superior hypogastric plexus blockPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Quality of recovery

The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.

Time frame: Postoperative day 1

Secondary Outcomes

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.

Time frame: Up to postoperative day 2

Postoperative Opioid Use

Postoperative opioid consumption during said time points

Time frame: 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.

Time frame: Up to postoperative day 90

The McGill Pain Questionnaire

The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain.

Time frame: 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))

Time frame: Intraoperative (During block performance)

Length of stay in post-anesthesia care unit (PACU) area

Total time in PACU area

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.