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Clinical Trials/NCT01074229
NCT01074229
Completed
N/A

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

Northwestern University1 site in 1 country75 target enrollmentMarch 2010

Overview

Phase
N/A
Intervention
Placebo
Conditions
Postoperative Pain
Sponsor
Northwestern University
Enrollment
75
Locations
1
Primary Endpoint
QoR40 on the Day After Surgery
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
October 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gildasio De Oliveira

Gildasio De Oliveira, M.D. Principal Investigator

Northwestern University

Eligibility Criteria

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

Arms & Interventions

Placebo

sterile normal saline as placebo

Intervention: Placebo

Drug .5% Ropivacaine

Instillation of 20 cc of 0.5% ropivacaine

Intervention: Drug .5% Ropivacaine

20 cc of 0.25% ropivacaine

Instillation of 20 cc of 0.25% ropivacaine

Intervention: 20 cc of 0.25% ropivacaine

Outcomes

Primary Outcomes

QoR40 on the Day After Surgery

Time Frame: 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 Outcomes

  • 24 Total Morphine Consumption(1 day)

Study Sites (1)

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