Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01743378|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : August 30, 2013
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 %||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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 %
- Total morphine consumption during first 24 hours postoperatively [ Time Frame: At 24 hours postoperatively ]
- Postoperative pain by visual analog scale at [ Time Frame: 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
- Postoperative nausea and vomiting [ Time Frame: 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 [ Time Frame: First 72 hours after surgery ]Length of hospital stay counted in days
- Time until mobilization [ Time Frame: First 24 hours postoperatively ]First mobilization defined as walking on the floor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743378
|Hvidovre, Hovedstaden, Denmark, 2650|