Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: Surgeon vs Anesthesia - Ultrasound Guidance

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.
 
ClinicalTrials.gov Identifier: NCT03577912
Recruitment Status : Completed
First Posted : July 5, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Cataldo, Beth Israel Deaconess Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The TAP block has been shown to provide postoperative analgesia following abdominal surgery.There are many methods to administer local anesthetic into the transversus abdominus plane to provide post-operative analgesia. The more prevalent method is for an anesthesia provider to inject local anesthetic into the plane using ultrasound guidance, before surgery or after the conclusion of surgery. Alternatively, a surgeon can administer the local anesthetic during the operation without additional time or expense using direct laparoscopic visualization. We propose to compare the two methods for non-inferiority, in the context of an established enhanced recovery after surgery (ERAS) program. Non-inferiority being established by no demonstrable difference in post-operative narcotic requirements and equivalent average pain scores.

Condition or disease Intervention/treatment Phase
Post Operative Analgesia Non-inferiority Trial Procedure: TAP block administered by Surgery Procedure: TAP block administered by Anesthesia Not Applicable

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, patient and observer blinded non-inferiority trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: patients, and all data collectors were blinded regarding which group the patients were in. Surgeons who performed the case were aware of the method used but were not involved with the data collection
Primary Purpose: Treatment
Official Title: Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: A Comparison Between Intraoperative Surgeon Administration by Direct Visualization vs Image Guided Administration by Anesthesiologist, a Prospective Randomized Controlled Trial
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : April 12, 2018
Actual Study Completion Date : July 31, 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: TAP block administered by Surgery
transversus abdominis (TAP) plane block is performed by the surgeon at the conclusion of the surgery, still under general anesthesia, prior to removing the trocars a single dose 60 cc of 0.5%bupivicaine is delivered into the TAP under direct surgeon observed laparoscopic visualization. (Split dose 30cc/side)
 Procedure: TAP block administered by Surgery
TAP block administered by Surgery
Active Comparator: TAP block administered by Anesthesia
transversus abdominis (TAP) plane block is performed by the anesthesiologist at the conclusion of the surgery after incisions are closed and dressing are on, prior to emergence from general anesthesia, a single dose 60 cc of 0.5%bupivicaine is delivered into the TAP under by the anesthesiologist using ultrasound visualization. (Split dose 30cc/side)
 Procedure: TAP block administered by Anesthesia
TAP block administered by Anesthesia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. narcotic requirement [ Time Frame: first 48 hours after surgery ]
    overall narcotic medications used by the patient (in morphine equivalents)PACU, 6,12,25,and 48 hours after surgery

  2. visual analogue pain scale - resting [ Time Frame: first 48 hours after surgery ]
    visual analogue pain scale 0-10 observed at rest in the post-anesthesia care unit, 6,12,25,and 48 hours after surgery (0 = no pain, 10 = worst imaginable pain)

  3. visual analogue pain scale - moving [ Time Frame: first 48 hours after surgery ]
    visual analogue pain scale 0-10 observed with motion in post-anesthesia care unit, 6,12,25,and 48 hours after surgery (0 = no pain, 10 = worst imaginable pain)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all consecutive patients undergoing laparoscopic colorectal resection in the division of colorectal surgery from March 2016 and April 2018 were eligible.
  • Over 18 years old
  • Intellect sufficient to sign consent, interpret analog pain scale

Exclusion Criteria:

  • allergies to bupivacaine or epinephrine
  • preoperative chronic narcotic usage
  • chronic pain syndrome
  • anatomy thought to preclude effective placement of the TAP.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT03577912


Locations
Layout table for location information
United States, Massachusetts
Beth Israel Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Thomas E Cataldo, MD Beth Israel Deaconess Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Thomas Cataldo, Instructor in Surgery, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03577912    
Other Study ID Numbers: 2014P000347
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Cataldo, Beth Israel Deaconess Medical Center:
ERAS
transversus_abdominis_plane_block
postoperative_pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs