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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01743378

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy	Procedure: TAP Block Ropivacaine 0,75 % Procedure: TAP Block Saline 0,9 %	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAP Block Ropivacaine 0,75 % Bilateral Transversus Abdominis Plane Block with 2 x 20 ml Ropivacaine 0,75 %	Procedure: TAP Block Ropivacaine 0,75 %
Placebo Comparator: TAP Block Saline 0,9 % Bilateral Transversus abdominis plane block with 2 x 20 ml Saline 0,9 %	Procedure: TAP Block Saline 0,9 %

Arm

Intervention/Treatment

Experimental: TAP Block Ropivacaine 0,75 %

Bilateral Transversus Abdominis Plane Block with 2 x 20 ml Ropivacaine 0,75 %

Procedure: TAP Block Ropivacaine 0,75 %

Placebo Comparator: TAP Block Saline 0,9 %

Bilateral Transversus abdominis plane block with 2 x 20 ml Saline 0,9 %

Procedure: TAP Block Saline 0,9 %

Outcome Measures

Primary Outcome Measures

Total morphine consumption during first 24 hours postoperatively [At 24 hours postoperatively]

Secondary Outcome Measures

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

Other Outcome Measures

Postoperative nausea and vomiting [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
Length of stay [First 72 hours after surgery]
Length of hospital stay counted in days
Time until mobilization [First 24 hours postoperatively]
First mobilization defined as walking on the floor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre Hospital	Hvidovre	Hovedstaden	Denmark	2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Billy B Kristensen, MD, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT01743378

Other Study ID Numbers:

H-1-2010-068

First Posted:

Dec 6, 2012

Last Update Posted:

Aug 30, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Pain, Postoperative

Ropivacaine

Study Results

No Results Posted as of Aug 30, 2013