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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01743378
Enrollment
48
Registered
2012-12-06
Start date
2011-02-28
Completion date
2013-06-30
Last updated
2013-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy

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.

Interventions

PROCEDURETAP Block Ropivacaine 0,75 %
PROCEDURETAP Block Saline 0,9 %

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total morphine consumption during first 24 hours postoperativelyAt 24 hours postoperatively

Secondary

MeasureTime frameDescription
Postoperative pain by visual analog scale atMonitored at 1, 2, 4, 6, 8 and 24 hours postoperativelyMonitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators at rest, when coughing and when walking

Other

MeasureTime frameDescription
Postoperative nausea and vomitingMonitored at 1, 2, 4, 6, 8 and 24 hours postoperativelyMonitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators
Length of stayFirst 72 hours after surgeryLength of hospital stay counted in days
Time until mobilizationFirst 24 hours postoperativelyFirst mobilization defined as walking on the floor

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026