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

This study is currently recruiting participants.
Verified April 2013 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01575028
First received: April 5, 2012
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Appendicitis
Drug: Ropivacaine
Drug: Bupivacaine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double Blinded, Randomized Comparison of Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Laparoscopic Appendectomy in the Pediatric Population

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Post-operative Pain Relief [ Time Frame: 12 hours post-operatively ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Local anesthetic infiltration injection
Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Drug: Bupivacaine
The local anesthetic at the incision sites will be injected by the surgeon.
Experimental: Transversus abdominis plane (TAP) block
Patients will receive a transversus abdominis plane (TAP) block.
Drug: Ropivacaine
The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally

Detailed Description:

The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. Despite the recognition of the importance of postoperative analgesia and the potential adverse effects of postoperative pain, significant pain occurs during the postoperative period in both the inpatient and outpatients settings. Specifically, appendectomy is one of the most common pediatric surgical procedures and is associated with significant postoperative pain. Additionally, although the use of opioid analgesics is generally safe, adverse effects do occur thereby mandating the use of alternative analgesic techniques when feasible. 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. These can include TAP block as well as wound infiltration with local anesthetic. The efficacy of TAP blocks in the setting of laparoscopic appendectomy has been demonstrated in both adult and pediatric populations, however its efficacy in comparison to local anesthetic infiltration is unclear.

The TAP block was first described by McDonnell et al. in 2004 for pain control of procedures involving the anterior abdominal wall. The skin, muscles, and parietal peritoneum in this region are innervated by the T7 through L1 nerve roots. The authors described deposition of local anesthetic in the plane between the internal oblique and the transversus abdominis muscle where the terminal branches of the T7 through L1 nerves lie. Since then, the TAP block has been shown to effectively provide analgesia for a variety of abdominal procedures. In 2007 an ultrasound guided approach was described by Hebbard et al. with a subsequent study concluding that an ultrasound guided TAP block provided superior analgesia than a blind technique.

The frequency of surgical appendectomy in both the inpatient surgical as well as the ambulatory setting justifies this comparison of effective analgesia. This study can certainly change the daily practice of the pediatric anesthesiologist in providing optimal care in patient and family satisfaction, as well as recovery.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575028

Contacts
Contact: N'Diris Barry, RN 614-355-3467 N'Diris.Barry@NationwideChildrens.org
Contact: Julie Rice, BSN 614-355-3142 Julie.Rice@NationwideChildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Tarun Bhalla, MD            
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Tarun Bhalla, MD Nationwide Childrens
  More Information

Publications:
Responsible Party: Tarun Bhalla, MD, Assistant Clinical Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01575028     History of Changes
Other Study ID Numbers: IRB12-00140
Study First Received: April 5, 2012
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
Transversus abdominis plane block
TAP block
Local anesthetic infiltration
Appendectomy
Laparoscopic appendectomy

Additional relevant MeSH terms:
Appendicitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anesthetics, Local
Bupivacaine
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013