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Completed

NCT Number: NCT01743378

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.

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Key information

Conditions

Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital

Hvidovre, Capital Region, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP Block Ropivacaine 0,75 %

Procedure

TAP Block Saline 0,9 %

Procedure

Primary outcomes

  1. Total morphine consumption during first 24 hours postoperatively

    Time frame: At 24 hours postoperatively

Secondary outcomes

  1. Postoperative pain by visual analog scale at

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

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

Other outcomes

  1. Postoperative nausea and vomiting

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

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

  2. Length of stay

    Time frame: First 72 hours after surgery

    Length of hospital stay counted in days

  3. Time until mobilization

    Time frame: First 24 hours postoperatively

    First mobilization defined as walking on the floor

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2012
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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