Two Doses of Dexmedetomidine as Adjuvent to Bupivacaine in Tap Block

NCT06624319 | Not Yet Recruiting

• 1 other identifier: 04-2024-200895
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study to determine the optimal dose of dexmedetomidine as an adjuvant to bupivacaine in U.S guided TAP block for preemptive analgesia In patients undergoing lower abdominal cancer surgeries.

Conditions

Post Operative Pain

Keywords

Tap block; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption during the first 24 hours postoperatively

  Morphine consumption during the First 24 hours postoperative

  First 24 hours postoperative

Secondary Outcomes (2)

• Severity of pain using Visual analogue scale

  First 24 hours postoperative

• Patient level of sedation using four point modified ramsy scale

  First 24 hours postoperative

Study Arms (2)

tap block with 0.5 μg/kg dexmedetomidine

ACTIVE COMPARATOR

will receive pre-emptive ultrasound-guided tap block with 0.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA.

Drug: Dexmedetomidine as adjuvent to bupvacaine in tap block

tap block with 1.5 μg/kg dexmedetomidine

ACTIVE COMPARATOR

will receive pre-emptive ultrasound-guided tap block with 1.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA.

Drug: Dexmedetomidine as adjuvent to bupvacaine in tap block

Interventions

Dexmedetomidine as adjuvent to bupvacaine in tap block DRUG

The analgesic effect of Two different doses of dexmedetomidine as adjuvent to bupivacaine in tap block

Also known as: Precedex

tap block with 0.5 μg/kg dexmedetomidine; tap block with 1.5 μg/kg dexmedetomidine

Eligibility Criteria

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

You may qualify if:

• age from 18 to 65 years old
• lower abdominal cancer surgery

You may not qualify if:

• patient refusal
• the local anesthetic allergy
• coagulopathy
• local infection at the procedure site
• psychic patients
• patient on chronic opioid use

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

South egypt cancer institute,Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kerolos S Tawfeek

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerolos S Tawfeek, Resident

CONTACT

+2001551990411; Kerolossalama7@gmail.com

Mohanad A Mohamed

CONTACT

+2001027068866; Mohanad.abosagheer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Patients will receive pre-emptive ultrasound-guided tap block with two different doses of dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA.

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

EG (1)