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Evaluation of Local Anesthetic at Incision Site

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ClinicalTrials.gov Identifier: NCT02483689
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Neil Raj Singhal, Valley Anesthesiology Consultants

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.


Condition or disease Intervention/treatment Phase
Post Operative Pain Appendicitis Drug: Pre Incisional Local Anesthetic Other: Pre-Incisional Saline Drug: Post-Closure Local Anesthetic Other: Post-Closure Saline Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Evaluation of Pre-incisional and Post-closure Local Anesthetic vs. Normal Saline on Postoperative Pain in Pediatric Appendectomies
Study Start Date : August 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
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
Other: Pre-Incisional Saline
Patient will be given a max of 30 cc injected through a 22g needle to area of incision.

Other: Post-Closure Saline
Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.

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
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 Name: Bupivicaine

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 Name: Bupivicaine




Primary Outcome Measures :
  1. Amount of Post Operative Pain Patients Experience [ Time Frame: 12 hours ]
    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 :
  1. The total amount of opioid use [ Time Frame: 24 Hours ]
    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.



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483689


Contacts
Contact: Raj Singhal, MD rsinghal@valley.md
Contact: Vanessa Pohl, BS 6029334482 vpohl@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Raj Singhal, M.D.    602-933-4482    rsinghal@valley.md   
Contact: Vanessa Pohl, B.S.    6029334482    vpohl@phoenixchildrens.com   
Sponsors and Collaborators
Valley Anesthesiology Consultants

Publications:

Responsible Party: Neil Raj Singhal, Doctor, Valley Anesthesiology Consultants
ClinicalTrials.gov Identifier: NCT02483689     History of Changes
Other Study ID Numbers: 15-047
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Neil Raj Singhal, Valley Anesthesiology Consultants:
Post Operative Pain
Appendicitis
Appendectomy
Local Anesthetic
Saline
Pain Management
Surgery
Recovery

Additional relevant MeSH terms:
Pain, Postoperative
Appendicitis
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents