Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery

Study Overview
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Brief Summary
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The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.

Official Title
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Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery

Conditions
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Pain, Postoperative, Anesthesia

Intervention / Treatment
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* Drug: TAP Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient undergoing laparoscopic hysterectomy Age ranges 18-80 Reading literacy English speaking Able to give informed consent Exclusion Criteria: History of relevant drug allergy Chronic opioid users who may have tolerance to pain medications Inability to understand written consent forms or give consent Age less than 18 or over 80 Any conversion to open surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP Block<br>20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance. | Drug: TAP Block<br>* Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia<br>* Other names: Ropivacaine with Epinephrine;|
| No Intervention: No Block<br>Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #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). | Postop Day #1 or Day #2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Use | narcotic use in mg of Morphine will be recorded | Postop Day #0 and Day #1 | 
| Visual Analog Scale (VAS) for Pain | 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.) | 2 and 24 hours post operative | 
| Intraoperative Time | The total time in the operating room will be recorded to see if there is a difference between groups. | the total intraoperative time in minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recovery, postoperative, pain, laparoscopy, hysterectomy, ropivacaine, TAP block, local anesthesia