Clinical Efficacy and Safety of Dexmedetomidine as an Adjuvant in Quadratus Lumborum Versus Epidural Block in Postoperative Lower Abdominal Cancer Surgeries
1 other identifier
interventional
54
1 country
1
Brief Summary
Clinical efficacy and safety of dexmedetomidine as an adjuvant in quadratus lumborum versus epidural block in postoperative patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2023
CompletedFirst Posted
Study publicly available on registry
November 14, 2023
CompletedStudy Start
First participant enrolled
April 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 1, 2025
November 1, 2025
9 months
November 5, 2023
November 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative analgesia
Time of first analgesic request during the first 24 hrs after surgery.
the first 24 hrs after surgery
Study Arms (2)
Group1:Ultrasound-guided quadratus lumborum block technique
OTHERUltrasound-guided quadratus lumborum block technique: the patients were placed in the lateral position. Following disinfecting of the site of injection, a convex probe (2-5 HZ, Edge, Sonosite, Seattle, the USA) was positioned in a parasagittal oblique plane at the L3-L4 level, which is approximately 4 cm from the posterior midline. The iliac crest, erector spinae (ES) muscle, QL muscle, and psoas (PM) muscle were identified, and a an 18-gauge Touhy's epidural needle (BBRAUN epidural set) was directed to the anterior part of the QL. Then, the needle tip was located between the QL and PM using the in-plane technique. Normal saline 5 mL was used to identify the plane. After confirmation of the injection site, 20 ml of 0.25% Bupivacaine bolus was injected and 1 μg/kg of dexmedetomidine dissolved in 2 ml normal saline were injected also between the QL and PM muscles divided equally on each side of the abdominal wall before induction general anesthesia.
Group2:Lumbar epidural block
OTHERLumbar epidural block: Under strict aseptic precautions, lumbar epidural was performed for patients in Group II using a 16-gauge Touhy epidural needle by a median approach. The L3 - L4 interspaces was chosen for the injection. The epidural space identified by the loss of resistance technique. The catheter was advanced 4 cm cephalad. When the aspiration test results for blood and cerebrospinal fluid were negative, a test dose of (3 mL) 2% lidocaine was given after the placement of the epidural catheter. In the epidural catheter a bolus dose of 15 ml bupivacaine 0.25% and 1 μg/kg of dexmedetomidine dissolved in 2 ml normal saline was injected before induction of general anesthesia.
Interventions
Comparing the efficacy of Dexmedetomidine in bilateral quadratus lumborum block versus lumbar epidural block on postoperative analgesia following major lower abdominal cancer surgery.
Eligibility Criteria
You may qualify if:
- patient's 18-70years old
- ASA I-II and NYHA I-II.
- type of surgery: major lower abdominal cancer surgery
You may not qualify if:
- Patients who refused to participate in the study.
- coagulation disorders.
- opioid dependence.
- sepsis or local infection at or near the vicinity of the block site.
- patients with psychiatric illnesses that would interfere with perception and assessment of pain.
- allergy to any of the studied drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, Egypt
Related Publications (3)
Xu W, Daneshmand S, Bazargani ST, Cai J, Miranda G, Schuckman AK, Djaladat H. Postoperative Pain Management after Radical Cystectomy: Comparing Traditional versus Enhanced Recovery Protocol Pathway. J Urol. 2015 Nov;194(5):1209-13. doi: 10.1016/j.juro.2015.05.083. Epub 2015 Aug 13.
PMID: 26021824BACKGROUNDPatel HD, Ball MW, Cohen JE, Kates M, Pierorazio PM, Allaf ME. Morbidity of urologic surgical procedures: an analysis of rates, risk factors, and outcomes. Urology. 2015 Mar;85(3):552-9. doi: 10.1016/j.urology.2014.11.034.
PMID: 25733265BACKGROUNDBhalla RG, Wang L, Chang SS, Tyson MD. Association between Preoperative Albumin Levels and Length of Stay after Radical Cystectomy. J Urol. 2017 Nov;198(5):1039-1045. doi: 10.1016/j.juro.2017.05.066. Epub 2017 May 19.
PMID: 28533006BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor/Demonstrator
Study Record Dates
First Submitted
November 5, 2023
First Posted
November 14, 2023
Study Start
April 20, 2024
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
December 1, 2025
Record last verified: 2025-11