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Completed

NCT Number: NCT03869047

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

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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Key information

Conditions

Anesthesia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Dexmedetomidine +bupivacaine

Drug

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

Bupivacaine

Drug

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

Primary outcomes

  1. 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

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

    Time frame: 1st 24 hour

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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