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

NCT ID: NCT02331563

Last Updated: 2015-09-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-11-30

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.

Detailed 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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

0.5% bupivacaine

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

Group Type: EXPERIMENTAL

0.25 % bupivacaine

Intervention Type: DRUG

ultrasound guided transvers abdominis plane block

dexmedetomidine added bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

ultrasound guided transvers abdominis plane block

Interventions

Dexmedetomidine

ultrasound guided transvers abdominis plane block

Intervention Type: DRUG

0.25 % bupivacaine

ultrasound guided transvers abdominis plane block

Intervention Type: DRUG

Other Intervention Names

precedex; 0.5% Marcaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kırıkkale University

OTHER

Sponsor Role: lead

Responsible Party

Ferda Yaman

assist prof dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferda Yaman, assist prof

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University School of Medicine

Locations

Kırıkkale University School of Medicine Department of Anaesthesiology and Reanimation

Kırıkkale, Yahşihan, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

20.10.2014/24/07

Identifier Type: -

Identifier Source: org_study_id