Evaluation of Local Anesthetic at Incision Site

Post Operative Pain Clinical Trial

Official title:

The Evaluation of Pre-incisional and Post-closure Local Anesthetic vs. Normal Saline on Postoperative Pain in Pediatric Appendectomies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02483689
• Other study ID #: 15-047
• Status: Recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2020

Study information

• Verified date: April 2018
• Source: Valley Anesthesiology Consultants
• Contact: Raj Singhal, MD
• Email: rsinghal[@]valley.md
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Appendicitis
• Pain, Postoperative
• Post Operative Pain

Intervention

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:
• Pre-Incisional Saline
Patient will be given a max of 30 cc injected through a 22g needle to area of incision.

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

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Valley Anesthesiology Consultants

Country where clinical trial is conducted

United States, 

References & Publications (14)

Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. — View Citation

Buckius MT, McGrath B, Monk J, Grim R, Bell T, Ahuja V. Changing epidemiology of acute appendicitis in the United States: study period 1993-2008. J Surg Res. 2012 Jun 15;175(2):185-90. doi: 10.1016/j.jss.2011.07.017. Epub 2011 Aug 9. — View Citation

Edwards TJ, Carty SJ, Carr AS, Lambert AW. Local anaesthetic wound infiltration following paediatric appendicectomy: a randomised controlled trial: Time to stop using local anaesthetic wound infiltration following paediatric appendicectomy? Int J Surg. 2011;9(4):314-7. doi: 10.1016/j.ijsu.2010.09.012. Epub 2011 Feb 13. — View Citation

Kang H, Kim BG. Intraperitoneal ropivacaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study. J Int Med Res. 2010 May-Jun;38(3):821-32. — View Citation

Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25. — View Citation

Masoomi H, Nguyen NT, Dolich MO, Mills S, Carmichael JC, Stamos MJ. Laparoscopic appendectomy trends and outcomes in the United States: data from the Nationwide Inpatient Sample (NIS), 2004-2011. Am Surg. 2014 Oct;80(10):1074-7. — View Citation

Oravsky M, Bak V, Schnorrer M. Laparoscopic versus open appendectomy in treatment of acute appendicitis. Bratisl Lek Listy. 2014;115(10):660-2. — View Citation

Palmes D, Röttgermann S, Classen C, Haier J, Horstmann R. Randomized clinical trial of the influence of intraperitoneal local anaesthesia on pain after laparoscopic surgery. Br J Surg. 2007 Jul;94(7):824-32. — View Citation

Reynolds SL, Jaffe DM. Diagnosing abdominal pain in a pediatric emergency department. Pediatr Emerg Care. 1992 Jun;8(3):126-8. — View Citation

Scholer SJ, Pituch K, Orr DP, Dittus RS. Clinical outcomes of children with acute abdominal pain. Pediatrics. 1996 Oct;98(4 Pt 1):680-5. — View Citation

Thanapal MR, Tata MD, Tan AJ, Subramaniam T, Tong JM, Palayan K, Rampal S, Gurunathan R. Pre-emptive intraperitoneal local anaesthesia: an effective method in immediate post-operative pain management and metabolic stress response in laparoscopic appendicectomy, a randomized, double-blinded, placebo-controlled study. ANZ J Surg. 2014 Jan-Feb;84(1-2):47-51. doi: 10.1111/j.1445-2197.2012.06210.x. Epub 2012 Oct 11. — View Citation

Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29. — View Citation

Woolf CJ. Evidence for a central component of post-injury pain hypersensitivity. Nature. 1983 Dec 15-21;306(5944):686-8. — View Citation

Wright JE. Controlled trial of wound infiltration with bupivacaine for postoperative pain relief after appendicectomy in children. Br J Surg. 1993 Jan;80(1):110-1. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 hours
Secondary	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.	24 Hours