Evaluation of Local Anesthetic at Incision Site
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 9 - 17 |
| Updated: | 5/4/2018 |
| Start Date: | August 2015 |
| End Date: | July 2020 |
| Contact: | Raj Singhal, MD |
| Email: | rsinghal@valley.md |
The Evaluation of Pre-incisional and Post-closure Local Anesthetic vs. Normal Saline on Postoperative Pain in Pediatric Appendectomies
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.
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.
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.
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.
Inclusion Criteria:
- Patients undergoing Appendectomy for acute non-perforated appendicitis Must be between
9-17 years old
Exclusion Criteria:
We found this trial at
1
site
1919 E Thomas Rd
Phoenix, Arizona 85006
Phoenix, Arizona 85006
(602) 933-1000
Phone: 602-933-4482
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