Adjuvant Effect of Dexmedetomidine in Ultrasound (USG) Guided Transvers Abdominis Plane Block

NCT02331563 | Withdrawn Phase 3

• 1 other identifier: 20.10.2014/24/07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D (n = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general anaesthesia. Total local anaesthetic volume was standardised with 20 ml each sides of the abdomen. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4, 5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.

Conditions

Postoperative Nausea and Vomiting

Keywords

dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• opioid requirement

  postoperative relief

  24 hr

Secondary Outcomes (1)

• postoperative nause and vomiting

  24 hrs

Study Arms (2)

0.5% bupivacaine

EXPERIMENTAL

group 1 receiving TAP block with 0.25% bupivacaine 20 ml for each side of abdomen Bupivacaine is a local anaesthetic agent. transvers abdominis plane block with %0.5 Bustesin which is diluated with normal saline

Drug: 0.25 % bupivacaine

dexmedetomidine added bupivacaine

ACTIVE COMPARATOR

group II receiving TAP block with 0.25% bupivacaine + 0.5 mcg/kg dexmedetomidine each side of abdomen

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

ultrasound guided transvers abdominis plane block

Also known as: precedex

dexmedetomidine added bupivacaine

0.25 % bupivacaine DRUG

ultrasound guided transvers abdominis plane block

Also known as: 0.5% Marcaine

0.5% bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients undergoing laparascopic cholecystectomy

You may not qualify if:

• Story of allergy to bupivacaine and dexmedetomidine
• The surgery preceeded to laparatomy
• Recent abdominal operation history

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University School of Medicine Department of Anaesthesiology and Reanimation

Kırıkkale, Yahşihan, 71451, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ferda Yaman, assist prof

  Kırıkkale University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist prof dr

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 6, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-01

Locations

TU (1)