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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Billy B Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01743378
First received: November 13, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention
Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy
Procedure: TAP Block Ropivacaine 0,75 %
Procedure: TAP Block Saline 0,9 %

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Total morphine consumption during first 24 hours postoperatively [ Time Frame: At 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain by visual analog scale at [ Time Frame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of hospital stay counted in days

  • Time until mobilization [ Time Frame: First 24 hours postoperatively ] [ Designated as safety issue: No ]
    First mobilization defined as walking on the floor


Enrollment: 48
Study Start Date: February 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 %

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743378

Locations
Denmark
Hvidovre Hospital
Hvidovre, Hovedstaden, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Billy B Kristensen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01743378     History of Changes
Other Study ID Numbers: H-1-2010-068
Study First Received: November 13, 2012
Last Updated: August 28, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014