Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
Primary Purpose
Appendicitis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring Transversus abdominis plane block, TAP block, Local anesthetic infiltration, Appendectomy, Laparoscopic appendectomy
Eligibility 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.)
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Local anesthetic infiltration injection
Transversus abdominis plane (TAP) block
Arm Description
Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Patients will receive a transversus abdominis plane (TAP) block.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01575028
First Posted
April 5, 2012
Last Updated
July 29, 2015
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01575028
Brief Title
Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was allowed to expire due to changes in standard care for the patient population within the NCH institution.
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Transversus abdominis plane block, TAP block, Local anesthetic infiltration, Appendectomy, Laparoscopic appendectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local anesthetic infiltration injection
Arm Type
Active Comparator
Arm Description
Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Arm Title
Transversus abdominis plane (TAP) block
Arm Type
Experimental
Arm Description
Patients will receive a transversus abdominis plane (TAP) block.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
The local anesthetic at the incision sites will be injected by the surgeon.
Primary Outcome Measure Information:
Title
Post-operative Pain Relief
Description
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.
Time Frame
12 hours post-operatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarun Bhalla, MD
Organizational Affiliation
Nationwide Childrens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17179269
Citation
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. Erratum In: Anesth Analg. 2007 May;104(5):1108.
Results Reference
background
PubMed Identifier
18020088
Citation
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.
Results Reference
background
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Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
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