Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy Clinical Trial
Official title:
Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Hvidovre Hospital | Hvidovre | Hovedstaden |
| Lead Sponsor | Collaborator |
|---|---|
| Hvidovre University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Postoperative nausea and vomiting | Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators | Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively | No |
| Other | Length of stay | Length of hospital stay counted in days | First 72 hours after surgery | No |
| Other | Time until mobilization | First mobilization defined as walking on the floor | First 24 hours postoperatively | No |
| Primary | Total morphine consumption during first 24 hours postoperatively | At 24 hours postoperatively | No | |
| Secondary | 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 | Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively | No |