Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Placebo; Drug: Drug .5% Ropivacaine; Drug: 20 cc of 0.25% ropivacaine

• Registration Number: NCT01074229
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Study Start: 2010-03
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2013-04-04
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-09
• Last Update Submitted: 2014-04-09
• Results First Posted: 2014-05-08
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Age: 18-64 years
• Surgery: Laparoscopic Hysterectomy surgery
• ASA status: I and II
• Fluent in English

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	sterile normal saline as placebo
Drug .5% Ropivacaine	Drug .5% Ropivacaine	Instillation of 20 cc of 0.5% ropivacaine
20 cc of 0.25% ropivacaine	20 cc of 0.25% ropivacaine	Instillation of 20 cc of 0.25% ropivacaine

Primary Outcome Measures

Name	Time	Method
QoR40 on the Day After Surgery	1 day	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.

Secondary Outcome Measures

Name	Time	Method
24 Total Morphine Consumption	1 day	Total 24 total morphine consumption post operative.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States