An interventional study of Pre Incisional Local Anesthetic and Pre-Incisional Saline in Post Operative Pain and Appendicitis, sponsored by Valley Anesthesiology Consultants. Status unknown at 1 site in United States. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by Valley Anesthesiology Consultants · Not applicable, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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 · Other: Post-Closure Saline
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 · 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
Also known as: Bupivicaine
Patient will be given a max of 30 cc injected through a 22g needle to area of incision.
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
Also known as: Bupivicaine
Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.
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.
Time frame: 12 hours
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.
Time frame: 24 Hours
Plan to share: No
The record gives a start of Aug 2015, a primary completion of Jul 2020 and a completion of Jul 2020. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
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