Clinical trial NCT02475031: Single-shot TAP Block vs Continuous TAP Block
Official title: Randomized, Prospective, Double Blind Study Comparing Single Shot Versus Continuous Transverses Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Live Donor Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: transversus abdominis plane block
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Halyard Health
First posted: 2015-06-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy

Detailed description: This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy.

Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use.

This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.

Eligibility criteria: Inclusion criteria:

* Healthy subject undergoing laparoscopic live donor nephrectomy
* (ASA) American Society of Anesthesiologists class 1 or 2
* Age 18 or older, male or female
* Desires TAP block for postoperative pain control

Exclusion criteria:

* Any contraindication for TAP block - single or continuous
* History of substance abuse
* Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
* Known allergy or other contraindications to the study medications (Ropivacaine, Normal Saline, Hydromorphone, Oxycodone and Acetaminophen)

Primary outcomes:
measure: Total Narcotic Usage at 48 Hours
timeFrame: 48 hours
Secondary outcomes:
measure: Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours
timeFrame: up to 60 hours
measure: Average Pain Scores
timeFrame: up to 60 hours
measure: Nausea Scores at 48 Hours
timeFrame: up to 48 hours
measure: Sedation Scores at 48 Hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Hospital
name: Yar Yeap, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
citation: McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
citation: McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
citation: Yeap YL, Wolfe JW, Kroepfl E, Fridell J, Powelson JA. Transversus abdominis plane (TAP) block for laparoscopic live donor nephrectomy: Continuous catheter infusion provides no additional analgesic benefit over single-injection ropivacaine. Clin Transplant. 2020 Jun;34(6):e13861. doi: 10.1111/ctr.13861. Epub 2020 Apr 9.