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

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03577912

Collaborator

(none)

Enrollment

Location

Arms

35.4

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

Purpose: To demonstrate that TAP blockade administered by the surgeon during surgery is as effective as when placed as a separate procedure by an anesthesiologist under ultrasound guidance by head to head randomized comparison controlling for medication, concentration volume and location.

Introduction:

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 ventral rami of the segmental thoracolumbar nerves course through the TAP before innervating the anterolateral abdominal wall. The TAP block has been shown to provide postoperative analgesia following abdominal surgery. Prospective randomized trials have demonstrated analgesic efficacy of TAP block and cadaveric studies have shown reliable dye spread from T9-L1 (iliac crest to the costal margin) , although the spread is dependent upon the technique of injection, single versus multiple injections. The TAP block is an intermuscular plane block i.e., needle placed in the plane between the internal oblique and transversus abdominis muscles. The sensory fibers located in this plane is too small to be visualized by ultrasound or localized by nerve stimulation. The TAP block may be performed in patients under general anesthesia since nerve localization is not necessary. This block has a number of advantages which include technical simplicity, high analgesic effectiveness, opioid sparing, long duration of effect, up to 36 hours, minimal side effects in comparison to that associated with neuraxial analgesia (e.g., hypotension, motor blockade). TAP block has successfully been incorporated in enhanced recovery after surgery (ERAS) protocols to reduce postoperative pain, reduce post op narcotic requirement, provide earlier return of bowel function and reduce length of stay. However multiple techniques for placement of the block have been described, in differing locations and with differing agents to analgesia after a variety of procedures. Historically the block has been placed based on anatomic land marks in the triangle of Petit guided by the sensation of the administrator. The safety and anatomic reliability of this approach has been questioned. Currently the block is frequently placed by an anesthesiologist under ultrasound guidance. Recently there have been published reports of surgeons placing TAP blocks intraoperatively guided by palpation and direct visualization, both open and with laparoscopic visualization . It is currently the practice in the division of colon and rectal surgery to use a standardized method for placing a TAP block after open and laparoscopic abdominal colon and rectal cases as part of our ERAS protocol requiring minimal time and cost limited to the cost of the medication. The authors hypothesize that TAP block administered by the surgeon is as effective as when administered by an anesthesiologist under ultrasonic guidance controlling for medication, volume, concentration and location of placement.

Methods: This study is a randomized trial with a placebo control arm to confirm effectiveness of the block its self, as TAP block is fully adopted as standard practice throughout abdominal surgery. Consecutive patients 18 years old or greater with intellectual capacity to consent, who are scheduled to undergo elective open or laparoscopic abdominal surgery by the division of colorectal surgery, will be offered inclusion in the study. Choice of open versus laparoscopic procedure is at surgeons discretion based on the patient's condition, diagnosis and best practice. Those patients whose procedure begins laparoscopically who require conversion to laparotomy will be noted and included in the open group. Exclusions will include patients who have allergies to the medications, patients with a preoperative addiction to narcotics or chronic pain syndromes requiring chronic medication, or whose anatomy or procedure precludes placement of the block.

Consenting patients will be randomized to receive administration of a TAP block either intraoperatively by the surgeon by direct palpation and/or visualization or by an anesthesiologist under ultrasound guidance. Secondary randomization will assign 1/4rd of both arms to receive placebo. In treatment arm cases Marcaine 0.25% with epinephrine 1:200,000 in a volume in ccs equal to the patients weight in Kg will be delivered. Those assigned to placebo will receive an equivalent volume of saline. In all cases the block will be placed at the conclusion of the case; for the surgeon, prior to closure of the abdomen, for the anesthesiologist after skin closure but prior to emergence from general anesthesia.

The volume will be divided equally, bilaterally and injection via needle and syringe into the transversus abdominis muscle plane lateral to the border of the rectus muscle at the level of the umbilicus. In cases of longer xyphoid to pubis laparotomy incisions the volume of injection can be further divided to be injected superiorly and inferiorly in the abdominal wall to assure adequate distribution. In all cases the injection will be performed under general anesthesia after the completion of the case either immediately before closure of the abdominal incision(s) or immediately after closure, prior to emergence from anesthesia.

The patients and the data collection staff will be blinded at to the medication vs placebo and the method of administration.

Post operatively all patients in all groups will be included in a standard post-operative ERAS pathway including use of intravenous ketorolac and acetaminophen, metoclopramide, early ambulation. All patients will have access to standard post-operative analgesia including intravenous narcotics (morphine, hydromorphone) patient controlled analgesia (PCA) and PO analgesia acetaminophen, ibuprofen, oxycodone.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, randomized, patient and observer blinded non-inferiority trialprospective, 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 :

Aug 17, 2015

Actual Primary Completion Date :

Apr 12, 2018

Actual Study Completion Date :

Jul 31, 2018

Arms and Interventions

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

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

Primary Outcome Measures

narcotic requirement [first 48 hours after surgery]
overall narcotic medications used by the patient (in morphine equivalents)PACU, 6,12,25,and 48 hours after surgery
visual analogue pain scale - resting [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)
visual analogue pain scale - moving [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator: Thomas E Cataldo, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Thomas Cataldo, Instructor in Surgery, Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT03577912

Other Study ID Numbers:

2014P000347

First Posted:

Jul 5, 2018

Last Update Posted:

Sep 17, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Cataldo, Instructor in Surgery, Beth Israel Deaconess Medical Center

ERAS

transversus_abdominis_plane_block

postoperative_pain

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Sep 17, 2018