Transversus Abdominis Plane Block After Robot-assisted Laparocopic Hysterectomy

Hysterectomy Clinical Trial

— TAP-block  

Official title:

Effekt of Transversus Abdominis Plane (TAP) Block After Robot-assisted Laparocopic Hysterectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01504386
• Other study ID #: SM1-HT-2011
• Status: Terminated
• Phase: Phase 4
• First received: December 30, 2011
• Last updated: August 21, 2013
• Start date: December 2011
• 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 National Committee on Health 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 robot-assisted laparoscopic hysterecomy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80

• BMI 17-40

• Written consent

• Can cooperate

Exclusion Criteria:

• Drug and alcohol abuse

• Consumption of opioids

• Drug allergy

• Infection at insertion point of needle

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

• Hysterectomy

Intervention

Procedure:
• 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 Univerity Hospital, Department of Anaesthesia	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	Total opioid consumption	Opioid consumption via PCA-pump	0-24 hours	No
Secondary	Pain during rest and cough	VAS-pain score at rest and at cough	1,2,4,8,18 and 24 hours	No
Secondary	Postoperative nausea and vomiting	Nausea score 0-3 No. of vomits	1,2,4,8,18 and 24 hours	No