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NCT06455540 Clinical Trial

SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)

Hysterectomy Clinical Trial

— SUBTLE  

Official title:
Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06455540
Other study ID # E2022273
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 16, 2024
Est. completion date December 31, 2025

Study information
Verified date June 2024
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 198
Est. completion date December 31, 2025
Est. primary completion date July 15, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Postoperative Opioid Use Postoperative opioid consumption during said time points Up to postoperative day 2
Secondary 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
Secondary The McGill Pain Questionnaire The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. Up to postoperative day 90
Secondary 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)
Secondary Length of stay in post-anesthesia care unit (PACU) area Total time in PACU area Postoperative day 1
Secondary 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
Secondary Postoperative nausea and vomiting number of participants with nausea or vomiting Up to postoperative day 2
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