Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy

April 7, 2024 updated by: Abdalla Mohamed Goda Mohamed, Zagazig University

Ultrasound Guided Quadratus Lumborum Block Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy

Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery.

Study Overview

Status

Active, not recruiting

Detailed Description

hypothesis: There is no difference between the analgesic effect of either Ultrasound guided QL block or laparoscopic Superior hypogastric plexus block on post laparoscopic hysterectomy pain.

Alternative hypothesis:

There is difference between the analgesic effect of either Ultrasound QL block or laparoscopic superior hypogastric plexus block on post laparoscopic hysterectomy pain.

Aim of the work Better achievement of effective analgesia with less opioid consumption and related side effects for post laparoscopic hysterectomy pain.

Objectives To assess effect of both ultrasound quadratus lumborum block and laparoscopic superior hypogastric plexus block on analgesic outcome (Visual Analogue Scale VAS, duration of analgesia) after laparoscopic hysterectomy. To compare between ultrasound quadratus lumborum block and laparoscopic superior hypogastric plexus block regarding to total opioid for postoperative analgesia after laparoscopic hysterectomy and patient satisfaction. To record side effects related to regional block ( e.g., local anesthetic toxicity, vascular and neural injury) and opioids ( neasuea, vomiting, respiratory depression

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sharkia
      • Zagazig, Sharkia, Egypt
        • Faculty of Medicine, Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent from the patient.
  2. BMI of less than or equal 30.0 kg m-2.
  3. Age 45-60 years old.
  4. American Society of Anesthesiologists (ASA) physical status classes I and II.Exclusion Criteria:

1. Allergy to local anesthetics. 2. Infection at site of injection. 3. Patients with coagulopathy. 4. Patients with chronic pain syndromes. 5. Physical and mental disease which could interfere with pain scores evaluation.

6. Patients with distorted local anatomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group QL:
patients will receive Ultrasound Guided bilateral QL lumborum block (Anterior Approch) by anesthesiologist (20 ml of 0.25% bupivacaine hydrochloride at each side).
Ultrasound Guided Quadratus Lumborum Block versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia after Laparoscopic Hysterectomy
Experimental: Group SH:
will receive laparoscopic Superior Hypogastric block by gynecologist (30 ml of 0.25% bupivacaine hydrochloride ).
Ultrasound Guided Quadratus Lumborum Block versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia after Laparoscopic Hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption decrease
Time Frame: 24hours
Avoid excessive usage of opioid by regional blocks
24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Eslam S Almaghawry Mohamed, MD, Faculty of Medicine, Zagazig University
  • Study Chair: Abdalla H Gad, MD, Faculty of Medicine, Zagazig University
  • Study Chair: Mohamed A Wasfy, MD, Faculty of Medicine, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 271/7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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