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Clinical Trials/NCT03869047
NCT03869047CompletedPhase 4

Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique :Prospective, Randomized Double- Blinded Study

Ain Shams University1 site in 1 country80 target enrollmentStarted: March 6, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
First time to analgesic requirement

Study Overview

Brief Summary

The purpose of this study is to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine only in anterior QLblock(transincisional) , where the local anesthetic will be applied before wound closure at the end of surgery through the wound . in combination with general anesthesia in elective open renal surgery with regard to Postoperative pain control,hemodynamic stability, and adverse effects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • physical status American Society of Anesthesiologist (ASA) I or II

Exclusion Criteria

  • Patients refusal
  • A body mass index (BMI) >30 kg/m2
  • ASA physical status >II
  • major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
  • Coagulation abnormalities
  • Infection at the injection site
  • Allergy or contraindications to the drugs used in the study
  • History of drug addiction or alcohol abuse
  • A psychiatric illness, or mental retardation interfering with the evaluation of pain scores or PCA programs .

Arms & Interventions

quadratus lumborum block(dexmedetomidine+bupivacaine)

Active Comparator

patients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine ,total volume 20 ml.

Intervention: Dexmedetomidine +bupivacaine (Drug)

quadratus lumborum block(bupivacaine)

Active Comparator

patients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20%.

Intervention: Bupivacaine (Drug)

Outcomes

Primary Outcomes

First time to analgesic requirement

Time Frame: 1st 24 hour postoperatively

After extubation, an intravenous patient - controlled system, will be connected to the patient (Accufuser plus 100 ml) will be prepared with 60 ml isotonic saline containing 60 mg morphine , it will be programmed to give 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first bolus will be recorded considering extubation time is the zero time

Secondary Outcomes

  • the secondary outcomes will be the total opioid consumption postoperatively(1st 24 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Ain Shams University

Study Sites (1)

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