Recruiting

Local Anesthetic

Sponsor:

Valley Anesthesiology Consultants

Code:

NCT02483689

Conditions

Post Operative Pain

Appendicitis

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

Interventions

Pre Incisional Local Anesthetic

Pre-Incisional Saline

Post-Closure Local Anesthetic

Post-Closure Saline

Study Details

Brief 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

Study ID

NCT02483689

Start date

Aug, 2015

Status verified date

Apr, 2018

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients undergoing Appendectomy for acute non-perforated appendicitis Must be between 9-17 years old

Exclusion Criteria:

  • n/a

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Saline

Patient will be given saline with a maximum of 30 cc 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

experimental: Local

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

Interventions

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

Pre-Incisional Saline

Patient will be given a max of 30 cc injected through a 22g needle to area of incision.

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

Post-Closure Saline

Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.

Primary outcome measure

  • Amount of Post Operative Pain Patients Experience [ Time Frame: 12 hours ]

Central Contacts and Locations

Central contacts

Raj Singhal, MD

rsinghal@valley.md

Vanessa Pohl, BS

6029334482vpohl@phoenixchildrens.com

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Raj Singhal, M.D.

602-933-4482rsinghal@valley.md

Vanessa Pohl, B.S.

6029334482vpohl@phoenixchildrens.com

More Information

Sponsor

Valley Anesthesiology Consultants

Last update posted

May 2, 2018

Last verified

Apr, 2018

Keywords

  • Post Operative Pain
  • Appendicitis
  • Appendectomy
  • Local Anesthetic
  • Saline
  • Pain Management
  • Surgery
  • Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Valley Anesthesiology Consultants on 2018-05-02.