Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery

Laparoscopic Colon Surgery Clinical Trial

Official title:

Effect of Transversus Abdominis Plane (TAP) Block as Postoperative Pain Management After Laparoscopic Colon Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418144
• Other study ID #: SM1-HT-2010
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2011
• Last updated: August 21, 2013
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 - 80

• BMI 18 - 40

• ASA 1 - 3

• Written consent

• Can cooperate

Exclusion Criteria:

• Mb Chron and Collitis Ulcerosa

• Drug and alcohol abuse

• Pregnancy

• Consumption of opioids

• Drug allergy

Study Design

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

Related Conditions & MeSH terms

• Laparoscopic Colon Surgery

Intervention

Procedure:
• Transversus abdominis plane (TAP) block
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%
• Placebo TAP block
Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane

Locations

Country	Name	City	State
Denmark	Herlev University Hospital, Department of anaesthesia	Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during cough	VAS-pain score	6 hours	No
Secondary	Pain during rest	VAS-pain score at rest	1,2,4,6,12 and 24 hours	No
Secondary	Total opioid consumption	Opioid consumption via PCA-pump.	0-24 hours	No
Secondary	Postoperative nausea and vomiting	Nausea score 0-3 No. of vomits	1,2,4,6,12,18 and 24 hours	No