Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery (TAP)
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|ClinicalTrials.gov Identifier: NCT01479270|
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : October 11, 2018
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Anesthesia||Drug: TAP Block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||January 2012|
Active Comparator: TAP Block
20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
Drug: TAP Block
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
Other Name: Ropivacaine with Epinephrine
No Intervention: No Block
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
- Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 [ Time Frame: Postop Day #1 or Day #2 ]40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).
- Narcotic Use [ Time Frame: Postop Day #0 and Day #1 ]narcotic use in mg of Morphine will be recorded
- Visual Analog Scale (VAS) for Pain [ Time Frame: 2 and 24 hours post operative ]visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)
- Intraoperative Time [ Time Frame: the total intraoperative time in minutes ]The total time in the operating room will be recorded to see if there is a difference between groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479270
|Principal Investigator:||Sarah M Kane, MD||MetroHealth Medical Center|