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

• ClinicalTrials.gov Identifier: NCT01575028
• Recruitment Status: Terminated
• First Posted: April 10, 2012
• Results First Posted: June 1, 2015
• Last Update Posted: August 24, 2015
• Sponsor: Nationwide Children's Hospital
• Information provided by (Responsible Party): Tarun Bhalla, MD, Nationwide Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Appendicitis	Drug: Ropivacaine; Drug: Bupivacaine	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: October 2012
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Post-operative Pain Relief [ Time Frame: 12 hours post-operatively ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Locations

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

Investigators

• Principal Investigator: Tarun Bhalla, MD; Nationwide Childrens

More Information

Publications:

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. Erratum in: Anesth Analg. 2007 May;104(5):1108.

Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.

• Responsible Party: Tarun Bhalla, MD, Assistant Clinical Professor, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT01575028
• Other Study ID Numbers: IRB12-00140
• First Posted: April 10, 2012
• Results First Posted: June 1, 2015
• Last Update Posted: August 24, 2015
• Last Verified: July 2015

Keywords provided by Tarun Bhalla, MD, Nationwide Children's Hospital:

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

Additional relevant MeSH terms:

Appendicitis; Intraabdominal Infections; Infection; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Bupivacaine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents