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

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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

Tracking Information
First Submitted Date  ICMJE April 5, 2012
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE May 14, 2015
Results First Posted Date  ICMJE June 1, 2015
Last Update Posted Date August 24, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
Official Title  ICMJE A Prospective, Double Blinded, Randomized Comparison of Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Laparoscopic Appendectomy in the Pediatric Population
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Appendicitis
Intervention  ICMJE
  • Drug: Ropivacaine
    The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
  • Drug: Bupivacaine
    The local anesthetic at the incision sites will be injected by the surgeon.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Bupivacaine
  • Experimental: Transversus abdominis plane (TAP) block
    Patients will receive a transversus abdominis plane (TAP) block.
    Intervention: Drug: Ropivacaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 7, 2014)
3
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
200
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575028
Other Study ID Numbers  ICMJE IRB12-00140
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tarun Bhalla, MD, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tarun Bhalla, MD Nationwide Childrens
PRS Account Nationwide Children's Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP