Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy
• Interventions: Procedure: TAP Block Ropivacaine 0,75 %; Procedure: TAP Block Saline 0,9 %

• Registration Number: NCT01743378
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy.

Two groups of each 24 patients. All patients are given general anesthesia. The patients are randomized to have a ultrasound guided bilateral transversus abdominis plane block with either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided with a PCA for self administration of morphine.

Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively as well as the total consumption of morphine after 24 hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Assigned to elective abdominal hysterectomy
• Must be able to understand and speak danish
• Must be able to give verbal and written consent

Exclusion Criteria

• Abuse of alcohol or medicin
• Daily treatment with opoids or glucocorticoids
• Allergy towards any kind of localanesthetic drug
• Intolerance toward morphine
• Psychiatric desease
• Age below 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block Ropivacaine 0,75 %	TAP Block Ropivacaine 0,75 %	Bilateral Transversus Abdominis Plane Block with 2 x 20 ml Ropivacaine 0,75 %
TAP Block Saline 0,9 %	TAP Block Saline 0,9 %	Bilateral Transversus abdominis plane block with 2 x 20 ml Saline 0,9 %

Primary Outcome Measures

Name	Time	Method
Total morphine consumption during first 24 hours postoperatively	At 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Postoperative pain by visual analog scale at	Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively	Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators at rest, when coughing and when walking

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, Hovedstaden, Denmark