Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01575028
Recruitment Status : Terminated (The study was allowed to expire due to changes in standard care for the patient population within the NCH institution.)
First Posted : April 10, 2012
Results First Posted : June 1, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575028


Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tarun Bhalla, MD Nationwide Childrens

Publications:
Layout table for additonal information
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
First Posted: April 10, 2012    Key Record Dates
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:
Layout table for 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