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

NCT03869047 | Completed Phase 4

• 1 other identifier: FMASU R 14/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

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

  1st 24 hour postoperatively

Secondary Outcomes (1)

• the secondary outcomes will be the total opioid consumption postoperatively

  1st 24 hour

Study Arms (2)

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.

Drug: Dexmedetomidine +bupivacaine

quadratus lumborum block(bupivacaine)

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

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

quadratus lumborum block(dexmedetomidine+bupivacaine)

Bupivacaine DRUG

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

quadratus lumborum block(bupivacaine)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: March 6, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 15, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)