RCT Superior Hypogastric Block During LH

Hysterectomy Clinical Trial

Official title:

Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283436
• Other study ID #: 2017P001804
• Status: Completed
• Phase: Phase 4
• Start date: January 18, 2018
• Est. completion date: February 21, 2019

Study information

• Verified date: October 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• Bupivacaine Hydrochloride 0.25% Injection Solution
10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Jon I. Einarsson	George Washington University, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Scores	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.	Admission to recovery unit and every hour after for 2 hours
Secondary	Postoperative Opioid Use	Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.	Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery
Secondary	Postoperative Pain Scores	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.	Discharge to 1 week after surgery, assessed up to 1 week after surgery