- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359743
Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy
Ultrasound Guided Quadratus Lumborum Block Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sharkia
-
Zagazig, Sharkia, Egypt
- Faculty of Medicine, Zagazig University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written informed consent from the patient.
- BMI of less than or equal 30.0 kg m-2.
- Age 45-60 years old.
- 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
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
Sponsor
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
General Publications
- Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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