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

Hvidovre University Hospital

Status: Completed

Conditions: Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy

Treatments: Procedure: TAP Block Ropivacaine 0,75 %; Procedure: TAP Block Saline 0,9 %

Study type: Interventional

Funder types: Other

Identifiers

NCT01743378

H-1-2010-068

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

TAP Block Ropivacaine 0,75 %

Experimental group

Description:

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

Treatment:

Procedure: TAP Block Ropivacaine 0,75 %

TAP Block Saline 0,9 %

Placebo Comparator group

Description:

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

Treatment:

Procedure: TAP Block Saline 0,9 %