Evaluation of Local Anesthetic at Incision Site
NCT02483689 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2018-05-02
Summary
Patient will have usual appendectomy surgery with an injection of local or saline at incision site either before or after the incision at random.
The clinical hypothesis of this trial is that pediatric patients who undergo a local anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain and therefore reduce the amount of analgesics required to keep the patient satisfied.
Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess the timing of local anesthetic injection affects postoperative pain.
Conditions
- Post Operative Pain
- Appendicitis
Interventions
- DRUG
-
Pre Incisional Local Anesthetic
Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure
- OTHER
-
Pre-Incisional Saline
Patient will be given a max of 30 cc injected through a 22g needle to area of incision.
- DRUG
-
Post-Closure Local Anesthetic
Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure
- OTHER
-
Post-Closure Saline
Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.
Sponsors & Collaborators
-
Valley Anesthesiology Consultants
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2020-07-31
- Completion
- 2020-07-31
Countries
- United States
Study Locations
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