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Completed

NCT Number: NCT03283436

RCT Superior Hypogastric Block During LH

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham & Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine Hydrochloride 0.25% Injection Solution

Drug

10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)

Other names: Bupivacaine

Primary outcomes

  1. Postoperative Pain Scores

    Time frame: 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 outcomes

  1. Postoperative Opioid Use

    Time frame: 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.

  2. Postoperative Pain Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jon I. Einarsson

Other

Collaborators

  • George Washington University
  • University of North Carolina

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2017
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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