Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery. Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics. Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%. This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.

Official Title
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The Effect of Pre-operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Laparoscopic Hysterectomy: a Prospective, Randomized, Blinded Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Drug .5% Ropivacaine
* Drug: 20 cc of 0.25% ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-64 years Surgery: Laparoscopic Hysterectomy surgery ASA status: I and II Fluent in English Exclusion Criteria: History of allergy to local anesthetics History of chronic opioid use Pregnant patients BMI greater than 30 Drop-out criteria: Patient or surgeon request Complications related to the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>sterile normal saline as placebo | Drug: Placebo<br>* placebo injection<br>* Other names: Sterile normal saline;|
| Active Comparator: Drug .5% Ropivacaine<br>Instillation of 20 cc of 0.5% ropivacaine | Drug: Drug .5% Ropivacaine<br>* .5% ropivacaine 20 mls on each side of abdomen<br>* Other names: .5% Ropivacaine;|
| Active Comparator: 20 cc of 0.25% ropivacaine<br>Instillation of 20 cc of 0.25% ropivacaine | Drug: 20 cc of 0.25% ropivacaine<br>* Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine<br>* Other names: .25% ropivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR40 on the Day After Surgery | QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Total Morphine Consumption | Total 24 total morphine consumption post operative. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Post Operative, Opioids, Laparoscopic, Surgery, Hysterectomy