NCT06130670

Brief Summary

Clinical efficacy and safety of dexmedetomidine as an adjuvant in quadratus lumborum versus epidural block in postoperative patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 5, 2023

Last Update Submit

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

OTHER

Ultrasound-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.

Other: nerve block

Group2:Lumbar epidural block

OTHER

Lumbar 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.

Other: nerve block

Interventions

Comparing the efficacy of Dexmedetomidine in bilateral quadratus lumborum block versus lumbar epidural block on postoperative analgesia following major lower abdominal cancer surgery.

Group1:Ultrasound-guided quadratus lumborum block techniqueGroup2:Lumbar epidural block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 26021824BACKGROUND
  • Patel 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: 25733265BACKGROUND
  • Bhalla 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

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Comparing the efficacy of Dexmedetomidine in bilateral quadratus lumborum block versus lumbar epidural block on postoperative analgesia following major lower abdominal cancer surgery
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

Locations