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

Primary Purpose

Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

TAP Block Ropivacaine 0,75 %

TAP Block Saline 0,9 %

About this trial

This is an interventional treatment trial for Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAP Block Ropivacaine 0,75 %

TAP Block Saline 0,9 %

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total morphine consumption during first 24 hours postoperatively

Secondary Outcome Measures

Postoperative pain by visual analog scale at

Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators at rest, when coughing and when walking

Full Information

NCT ID

NCT01743378

First Posted

November 13, 2012

Last Updated

August 28, 2013

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01743378

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAP Block Ropivacaine 0,75 %

Arm Type

Experimental

Arm Description

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

Arm Title

TAP Block Saline 0,9 %

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

TAP Block Ropivacaine 0,75 %

Intervention Type

Procedure

Intervention Name(s)

TAP Block Saline 0,9 %

Primary Outcome Measure Information:

Title

Total morphine consumption during first 24 hours postoperatively

Time Frame

At 24 hours postoperatively

Secondary Outcome Measure Information:

Title

Postoperative pain by visual analog scale at

Description

Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators at rest, when coughing and when walking

Time Frame

Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively

Other Pre-specified Outcome Measures:

Title

Postoperative nausea and vomiting

Description

Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators

Time Frame

Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively

Title

Length of stay

Description

Length of hospital stay counted in days

Time Frame

First 72 hours after surgery

Title

Time until mobilization

Description

First mobilization defined as walking on the floor

Time Frame

First 24 hours postoperatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Hvidovre Hospital

City

Hvidovre

State/Province

Hovedstaden

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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