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

NCT03577912 | Completed DMC

• 1 other identifier: 2014P000347
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Analgesia; Non-inferiority Trial

Keywords

ERAS; transversus_abdominis_plane_block; postoperative_pain

Outcome Measures

Primary Outcomes (3)

• narcotic requirement

  overall narcotic medications used by the patient (in morphine equivalents)PACU, 6,12,25,and 48 hours after surgery

  first 48 hours after surgery

• visual analogue pain scale - resting

  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)

  first 48 hours after surgery

• visual analogue pain scale - moving

  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)

  first 48 hours after surgery

Study Arms (2)

TAP block administered by Surgery

ACTIVE COMPARATOR

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 Anesthesia

ACTIVE COMPARATOR

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

Interventions

TAP block administered by Surgery PROCEDURE

TAP block administered by Surgery

TAP block administered by Surgery

TAP block administered by Anesthesia PROCEDURE

TAP block administered by Anesthesia

TAP block administered by Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• allergies to bupivacaine or epinephrine
• preoperative chronic narcotic usage
• chronic pain syndrome
• anatomy thought to preclude effective placement of the TAP.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (25)

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  PMID: 31485929 DERIVED

Study Officials

• Thomas E Cataldo, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Surgery

Model Details: prospective, randomized, patient and observer blinded non-inferiority trial

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 5, 2018
• Study Start: August 17, 2015
• Primary Completion: April 12, 2018
• Study Completion: July 31, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)