Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies

NCT01575028 | Terminated Phase 2 Results DMC

• 1 other identifier: IRB12-00140
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, double-blinded, randomized comparison of 2 patient cohorts. One group of patients will receive a transversus abdominis plane (TAP) block. The second group will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery for a laparoscopic appendectomy. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia to compare the most appropriate delivery of effective analgesia. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of multimodal techniques in infants and children.

Conditions

Appendicitis

Keywords

Transversus abdominis plane block; TAP block; Local anesthetic infiltration; Appendectomy; Laparoscopic appendectomy

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain Relief

  Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.

  12 hours post-operatively

Study Arms (2)

Local anesthetic infiltration injection

ACTIVE COMPARATOR

Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.

Drug: Bupivacaine

Transversus abdominis plane (TAP) block

EXPERIMENTAL

Patients will receive a transversus abdominis plane (TAP) block.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally

Transversus abdominis plane (TAP) block

Bupivacaine DRUG

The local anesthetic at the incision sites will be injected by the surgeon.

Local anesthetic infiltration injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II
• Patients \> 4 years of age
• Weight less than or equal to 60 kg
• Presenting for laparoscopic appendectomy

You may not qualify if:

• ASA physical status \> II
• Patients \< 4 years of age
• Weight greater than 60 kg
• Patients presenting for ruptured appendectomy surgical procedures
• Co-morbid diseases (cardiac, pulmonary (not including asthma), neurological disease)
• Patients having concomitant procedures (circumcision, orchiopexy, etc.)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• 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.

  PMID: 17179269 BACKGROUND

• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

  PMID: 18020088 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Tarun Bhalla
• Organization: Nationwide Children's Hospital

Tarun.Bhalla@NationwideChildrens.org

(614) 722-4200

Study Officials

• Tarun Bhalla, MD

  Nationwide Childrens

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 10, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 24, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-07

Locations

US (1)