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CompletedNCT03869047Updated May 19, 2020

Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique

A Phase 4 interventional study of Dexmedetomidine +bupivacaine and Bupivacaine in Anesthesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Anesthesia
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In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 .
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    quadratus lumborum block(dexmedetomidine+bupivacaine)

    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.

    Drug: Dexmedetomidine +bupivacaine

  • Active comparator
    quadratus lumborum block(bupivacaine)

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

    Drug: Bupivacaine

Interventions

  • DrugDexmedetomidine +bupivacaine

    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

  • DrugBupivacaine

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

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What researchers measure

Primary outcomes

  1. First time to analgesic requirement

    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

    Time frame: 1st 24 hour postoperatively

Secondary outcomes

  1. the secondary outcomes will be the total opioid consumption postoperatively

    PCA will prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min.

    Time frame: 1st 24 hour

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Study locations

1 site
  • Ain Shams University hospitals
    Cairo, Egypt
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03869047
Lead sponsor
Ain Shams University
Responsible party
Amin Mohammed Alansary Amin Ahmed Helwa (Assistant professor, Ain Shams University) — Principal investigator
First posted
Mar 11, 2019
Start date
Mar 6, 2019
Primary completion
Aug 1, 2019
Completion
Aug 15, 2019
Last update
May 19, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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