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Evaluation of Local Anesthetic at Incision Site

Primary Purpose

Post Operative Pain, Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre Incisional Local Anesthetic
Pre-Incisional Saline
Post-Closure Local Anesthetic
Post-Closure Saline
Sponsored by
Valley Anesthesiology Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Post Operative Pain, Appendicitis, Appendectomy, Local Anesthetic, Saline, Pain Management, Surgery, Recovery

Eligibility Criteria

9 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • n/a

Sites / Locations

  • Phoenix Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline

Local

Arm Description

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

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

Outcomes

Primary Outcome Measures

Amount of Post Operative Pain Patients Experience
The subjects will be assessed for post-operative pain immediately upon wakening, then at 1, 2, 4, 8, and 12 hours after procedure.

Secondary Outcome Measures

The total amount of opioid use
This will be completed by looking at the total amount of morphine equivalants given to the patient during the first 24 hours of their hospital stay.

Full Information

First Posted
June 22, 2015
Last Updated
April 30, 2018
Sponsor
Valley Anesthesiology Consultants
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1. Study Identification

Unique Protocol Identification Number
NCT02483689
Brief Title
Evaluation of Local Anesthetic at Incision Site
Official Title
The Evaluation of Pre-incisional and Post-closure Local Anesthetic vs. Normal Saline on Postoperative Pain in Pediatric Appendectomies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valley Anesthesiology Consultants

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a prospective randomized-controlled pilot study of 100 pediatric subjects, recruited through Phoenix Children's Hospital and Pediatric Surgeons of Phoenix, who will undergo a laparoscopic appendectomy (LA) for acute non-perforated appendicitis. The reviewer and subject will be blind to the treatment to help prevent bias. The subjects will be randomized by envelope using a random number generator, and the infiltrated solution will be given to the surgeon by the pharmacy. The subjects will be approached preoperatively and will be divided into three groups: pre-incisional injection of local anesthetic, post-incisional injection of local anesthetic, and (pre or post) injection of saline as the control. All patients will have a standard 3 port laparoscopic appendectomy, port placement, port and instrument type, and operative technique will be determined by the surgeon's usual practice. On induction, the following protocol will be utilized: a 2 mg/kg bolus of propofol, 1.5 mg/kg of lidocaine, 0.1 mg/kg of morphine, and 0.6 mg/kg of rocuronium. A standardized anesthetic, using a mixture of sevoflurane in oxygen and air, will be utilized. Once the appendectomy is complete, a single dose of 0.5 mg/kg of ketorolac will be given prior to extubation. A total of 0.5 mL/kg of 0.25% Bupivicaine or saline, up to a maximum of 30 cc, will be injected using a 22g needle. Pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; post-closure local will be injected intradermally after closure. The subjects will be assessed for postoperative pain immediately upon wakening, and then 1, 2, 4, 8, 12, and 24 hours after the LA procedure by the bedside nurse by using the VAS and by measuring the total amount of opioid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Appendicitis
Keywords
Post Operative Pain, Appendicitis, Appendectomy, Local Anesthetic, Saline, Pain Management, Surgery, Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Local
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Pre Incisional Local Anesthetic
Other Intervention Name(s)
Bupivicaine
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Pre-Incisional Saline
Intervention Description
Patient will be given a max of 30 cc injected through a 22g needle to area of incision.
Intervention Type
Drug
Intervention Name(s)
Post-Closure Local Anesthetic
Other Intervention Name(s)
Bupivicaine
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Post-Closure Saline
Intervention Description
Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.
Primary Outcome Measure Information:
Title
Amount of Post Operative Pain Patients Experience
Description
The subjects will be assessed for post-operative pain immediately upon wakening, then at 1, 2, 4, 8, and 12 hours after procedure.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
The total amount of opioid use
Description
This will be completed by looking at the total amount of morphine equivalants given to the patient during the first 24 hours of their hospital stay.
Time Frame
24 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing Appendectomy for acute non-perforated appendicitis Must be between 9-17 years old Exclusion Criteria: n/a
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raj Singhal, MD
Email
rsinghal@valley.md
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Pohl, BS
Phone
6029334482
Email
vpohl@phoenixchildrens.com
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Singhal, M.D.
Phone
602-933-4482
Email
rsinghal@valley.md
First Name & Middle Initial & Last Name & Degree
Vanessa Pohl, B.S.
Phone
6029334482
Email
vpohl@phoenixchildrens.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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2239906
Citation
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Citation
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Results Reference
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Evaluation of Local Anesthetic at Incision Site

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