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

Anesthesia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869047
• Other study ID #: FMASU R 14/2019
• Status: Completed
• Phase: Phase 4
• Start date: March 6, 2019
• Est. completion date: August 15, 2019

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 15, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1st 24 hour postoperatively
Secondary	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.	1st 24 hour