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Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT03958942
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Abd El-Rahman, Assiut University

Brief Summary:
This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Inflammatory Response Other: Ultrasound quadratus lumborum block with bupivacaine 25% Other: lumbar epideural block with bupivacaine 25% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bilateral Ultrasound Guided Quadratus Lumborum Block Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response Following Major Lower Abdominal Cancer Surgery
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: quadratus lumborum block
received pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA.
Other: Ultrasound quadratus lumborum block with bupivacaine 25%
echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle

Active Comparator: lumbar epideural block
received pre-emptive lumbar epidural block with 15 mL of 0.25% bupivacaine before induction of GA.
Other: lumbar epideural block with bupivacaine 25%
lumbar epidural will be performed for patients in group II using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces will be chosen for the injection. The epidural space identified by the loss of resistance technique.




Primary Outcome Measures :
  1. postoperative pain [ Time Frame: first 24 hours postoperatively ]
    postoperative pain intensity.


Secondary Outcome Measures :
  1. postoperative inflammatory response [ Time Frame: first 24 hours postoperatively ]
    inflammatory response represented by the levels of: interleukins 1,6, and tumor necrosis factor alpha

  2. side effects [ Time Frame: first 24 hours postoperatively ]
    sedation, nausea, vomiting, and respiratory depression



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA II, III
  • Weight 50 - 85 kg.
  • Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).

Exclusion Criteria:

  • Patients with a history of relevant drug allergy.
  • Coagulation disorders.
  • Opioid dependence.
  • Sepsis.
  • Local infection at the vicinity of the block site.
  • Patients with psychiatric illnesses that would interfere with perception and assessment of pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958942


Contacts
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Contact: Ahmad M Abd El-Rahman, M.D. 00201149606060 ahmad23679@gmail.com

Locations
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Egypt
South Egypt Cancer Institute Recruiting
Assiut, Egypt, 171516
Contact: Moaaz El tohamy         
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmad Mohammad Abd El-Rahman, assisstant professor of Anesthesia, ICU, and Pain Management, Assiut University
ClinicalTrials.gov Identifier: NCT03958942     History of Changes
Other Study ID Numbers: 255
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents