SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)
- Conditions
- Hysterectomy
- Interventions
- Procedure: Superior hypogastric plexus block
- Registration Number
- NCT06455540
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief Summary
This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 198
- Able to provide informed consent
- Undergoing laparoscopic hysterectomy for benign indications
- Planned procedure that requires dissection of the presacral space
- Allergy to block medication (s)
- Known or suspected malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nerve block Superior hypogastric plexus block The superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride. Placebo block Superior hypogastric plexus block The superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline.
- Primary Outcome Measures
Name Time Method Quality of recovery Postoperative day 1 The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
- Secondary Outcome Measures
Name Time Method The McGill Pain Questionnaire Up to postoperative day 90 The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain.
Postoperative Pain Scores Up to postoperative day 2 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.
Postoperative Opioid Use Up to postoperative day 2 Postoperative opioid consumption during said time points
Quality of recovery Up to postoperative day 2 The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
Postoperative nausea and vomiting Up to postoperative day 2 number of participants with nausea or vomiting
The Brief Pain Inventory (BPI) Up to postoperative day 90 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.
Incidence of Adverse events Intraoperative (During block performance) Incidence of adverse events related to the plexus block (vascular puncture, hematoma, and local anesthetic systemic toxicity (LAST))
Length of stay in post-anesthesia care unit (PACU) area Postoperative day 1 Total time in PACU area