An interventional study of TAP block administered by Surgery and TAP block administered by Anesthesia in Post Operative Analgesia and Non-inferiority Trial, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-17.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 Surgery
TAP block administered by Anesthesia
narcotic requirement
overall narcotic medications used by the patient (in morphine equivalents)PACU, 6,12,25,and 48 hours after surgery
Time frame: 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)
Time frame: 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)
Time frame: first 48 hours after surgery
Plan to share: No
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