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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Withdrawn

Phase

Phase 3

Locations

Turkey

Study Type

Interventional

Intervention

Dexmedetomidine

0.25 % bupivacaine

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring dexmedetomidine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kırıkkale University School of Medicine Department of Anaesthesiology and Reanimation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

0.5% bupivacaine

dexmedetomidine added bupivacaine

Arm Description

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

Outcomes

Primary Outcome Measures

opioid requirement

postoperative relief

Secondary Outcome Measures

postoperative nause and vomiting

patient relief

Full Information

NCT ID

NCT02331563

First Posted

January 1, 2015

Last Updated

September 3, 2015

Sponsor

Kırıkkale University

1. Study Identification

Unique Protocol Identification Number

NCT02331563

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Withdrawn

Why Stopped

patients should have assurance to attend this study, money is the main problem

Study Start Date

October 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kırıkkale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

dexmedetomidine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.5% bupivacaine

Arm Type

Experimental

Arm Description

Arm Title

dexmedetomidine added bupivacaine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

precedex

Intervention Description

ultrasound guided transvers abdominis plane block

Intervention Type

Drug

Intervention Name(s)

0.25 % bupivacaine

Other Intervention Name(s)

0.5% Marcaine

Intervention Description

ultrasound guided transvers abdominis plane block

Primary Outcome Measure Information:

Title

opioid requirement

Description

postoperative relief

Time Frame

24 hr

Secondary Outcome Measure Information:

Title

postoperative nause and vomiting

Description

patient relief

Time Frame

24 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ferda Yaman, assist prof

Organizational Affiliation

Kırıkkale University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kırıkkale University School of Medicine Department of Anaesthesiology and Reanimation

City

Kırıkkale

State/Province

Yahşihan

ZIP/Postal Code

71451

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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