A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Techniques

NCT02538679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2018-03-27

Study results available
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Summary

Postoperative pain can pose significant challenges in the postoperative recovery of patients undergoing major colorectal surgery. Traditionally, opioids have played an important role in treating postoperative pain. It is well established that opioids are highly effective in relieving pain; however opioids are associated with numerous side effects that include nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus, drowsiness, sedation, and allergic reaction. These opioid side effects, which range in severity, can significantly interfere with discharge home following colorectal surgery. Significant interest exists in the use of local anesthetic based regional anesthesia techniques as a means to extend the analgesic window for patients undergoing colorectal surgery. Specifically, the use of the transversus abdominis plane (TAP) block as an adjunct in postoperative pain control has been widely reported in the anesthesia and colorectal surgery literature. Historically, the block was performed in a blind fashion with relative success and presently the block is typically performed either with ultrasound guidance or laparoscopic visualization. While TAP block has shown to be effective in post-operative pain control, the techniques used to place the block have not formally been compared.

The investigators are purposing a prospective, patient-blinded, randomized study of patients undergoing major colorectal surgery to compare TAP block under ultrasound guidance versus laparoscopic visualization versus no TAP block. The investigators hypothesize that laparoscopic-guided TAP block is non-inferior to ultrasound-guided TAP block with respect to perioperative pain control and either technique is superior to no TAP. In addition the investigators will measure procedural time, any adverse events related to the block, overall postoperative analgesic requirement, analgesic duration, postoperative pain scores, length of postoperative hospital stay, incidence of postoperative ileus, and overall patient satisfaction between the three groups.

Conditions

Interventions

OTHER

Placebo

The usual intraoperative and postoperative pain control; NO TAP block performed

DRUG

US TAP Bupivacaine/Epinephrine

Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.

DRUG

Lap TAP Bupivacaine/Epinephrine

Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Karen Zaghiyan, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-07
Primary Completion
2017-04-30
Completion
2017-04-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538679 on ClinicalTrials.gov