Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy (TAP HYS)
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|ClinicalTrials.gov Identifier: NCT01074229|
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Placebo Comparator: Placebo
sterile normal saline as placebo
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
- 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.
- 24 Total Morphine Consumption [ Time Frame: 1 day ]Total 24 total morphine consumption post operative.
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 ClinicalTrials.gov identifier (NCT number): NCT01074229
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Gildasio DeOliveira, MD||Northwestern University|