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Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy (TAP HYS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01074229
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Information provided by (Responsible Party):
Gildasio De Oliveira, 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Placebo Drug: Drug .5% Ropivacaine Drug: 20 cc of 0.25% ropivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Placebo Comparator: Placebo
sterile normal saline as placebo
Drug: Placebo
placebo injection
Other Name: Sterile normal saline

Active Comparator: Drug .5% Ropivacaine
Instillation of 20 cc of 0.5% ropivacaine
Drug: Drug .5% Ropivacaine
.5% ropivacaine 20 mls on each side of abdomen
Other Name: .5% Ropivacaine

Active Comparator: 20 cc of 0.25% ropivacaine
Instillation of 20 cc of 0.25% ropivacaine
Drug: 20 cc of 0.25% ropivacaine
Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine
Other Name: .25% ropivacaine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 24 Total Morphine Consumption [ Time Frame: 1 day ]
    Total 24 total morphine consumption post operative.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01074229

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Gildasio DeOliveira, MD Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University Identifier: NCT01074229    
Other Study ID Numbers: STU00023440
First Posted: February 24, 2010    Key Record Dates
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014
Last Verified: April 2014
Keywords provided by Gildasio De Oliveira, Northwestern University:
Post Operative
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents