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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01074229
First received: February 22, 2010
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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 Intervention
Postoperative Pain
Drug: Placebo
Drug: Drug .5% Ropivacaine
Drug: 20 cc of 0.25% ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • QoR40 on the Day After Surgery [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • 24 Total Morphine Consumption [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Total 24 total morphine consumption post operative.


Enrollment: 75
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074229

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01074229     History of Changes
Other Study ID Numbers: STU00023440
Study First Received: February 22, 2010
Results First Received: April 4, 2013
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pain
Post Operative
Opioids
Laparoscopic
Surgery
Hysterectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014