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

Postoperative Nausea and Vomiting Clinical Trial

— USG  

Official title:

Adjuvant Effect of Dexmedetomidine for the Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Laparascopic Cholecystectomy: a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02331563
• Other study ID #: 20.10.2014/24/07
• Status: Withdrawn
• Phase: Phase 3
• First received: January 1, 2015
• Last updated: September 3, 2015
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2015
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Transversus abdominis plane (TAP) block has been shown to provide postoperative pain relief following various abdominal and inguinal surgeries. The aim of this randomised controlled trial was to assess the effect of transversus abdominis plane (TAP) blocks on opioid requirements and median hospitai stay, postoperative nause and vomitting in patients undergoing laparoscopic cholecystectomy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patients undergoing laparascopic cholecystectomy

Exclusion Criteria:

• Story of allergy to bupivacaine and dexmedetomidine

• The surgery preceeded to laparatomy

• Recent abdominal operation history

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting

Intervention

Drug:
• Dexmedetomidine
ultrasound guided transvers abdominis plane block
• 0.25 % bupivacaine
ultrasound guided transvers abdominis plane block

Locations

Country	Name	City	State
Turkey	Kirikkale University School of Medicine Department of Anaesthesiology and Reanimation	Kirikkale	Yahsihan

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid requirement	postoperative relief	24 hr	Yes
Secondary	postoperative nause and vomiting	patient relief	24 hrs	Yes