RCT Superior Hypogastric Block During LH

Phase 4

Completed

• Conditions: Hysterectomy
• Interventions: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution

• Registration Number: NCT03283436
• Lead Sponsor: Jon I. Einarsson

Brief Summary

The goal of this study is to assess the efficacy of a superior hypogastric plexus block (SHPB) for pain relief following a laparoscopic hysterectomy.

Detailed Description

The objective of this study is to assess the efficacy of a SHPB for pain relief following laparoscopic hysterectomy. The superior hypogastric plexus lies in the presacral space and supplies autonomic innervation to the central pelvis. This plexus is suspected to play a role in postoperative pain following a hysterectomy. The investigators hypothesize that a SHPB using the anesthetic bupivacaine will reduce patients' pain scores and opioid consumption following a laparoscopic hysterectomy. Intraoperative and immediate postoperative opioid consumption will be collected from the Medication Administration Record by the nursing staff. The nursing staff will also be asked to complete a recovery worksheet that details the Visual Analog Scale pain score and opioid administration on admission to the recovery unit and every postoperative hour until six hours or the patient is discharged. Patients will also be asked to complete a daily diary for one week following the procedure, which details their pain level and daily opioid consumption. Patients will be followed for thirty days after surgery to assess for the occurrence of any postoperative complications. Detailed patient and procedure characteristics including age, race, body mass index, parity, surgical history, surgery indication, procedure type, and surgical approach will also be collected.

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-14
• Study Start: 2018-01-18
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Results First Submitted: 2020-08-12
• Results First Submitted QC: 2020-08-27
• Results First Posted: 2020-09-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-04
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Over age 18
• English Speaking
• Able to provide informed consent
• Undergoing laparoscopic hysterectomy for benign indications

Exclusion Criteria

• Planned laparotomy incision
• Planned procedure that requires dissection of the presacral space
• Allergy to block medication (s)
• Known or suspected malignancy
• Non-English speaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superior hypogastric plexus block	Bupivacaine Hydrochloride 0.25% Injection Solution	Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. 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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Scores	Admission to recovery unit and every hour after for 2 hours	The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.

Secondary Outcome Measures

Name	Time	Method
Postoperative Opioid Use	Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery	Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
Postoperative Pain Scores	Discharge to 1 week after surgery, assessed up to 1 week after surgery	Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.

Trial Locations

Locations (2)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States