NCT02483689

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

4.9 years

First QC Date

June 22, 2015

Last Update Submit

April 30, 2018

Conditions

Post Operative PainAppendicitis

Keywords

Post Operative PainAppendicitisAppendectomyLocal AnestheticSalinePain ManagementSurgeryRecovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The total amount of opioid use

    24 Hours

Study Arms (2)

Saline

PLACEBO COMPARATOR

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 SalineOther: Post-Closure Saline

Local

EXPERIMENTAL

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 AnestheticDrug: Post-Closure Local Anesthetic

Interventions

Pre Incisional Local AnestheticDRUG

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
Local
Pre-Incisional SalineOTHER

Patient will be given a max of 30 cc injected through a 22g needle to area of incision.

Saline
Post-Closure Local AnestheticDRUG

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
Local
Post-Closure SalineOTHER

Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.

Saline

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Related 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. doi: 10.1093/oxfordjournals.aje.a115734.

    PMID: 2239906BACKGROUND

  • 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.

    PMID: 22099604BACKGROUND

  • 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.

    PMID: 21324384BACKGROUND

  • 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. doi: 10.1177/147323001003800309.

    PMID: 20819419BACKGROUND

  • 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.

    PMID: 24112856BACKGROUND

  • 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.

    PMID: 25264663BACKGROUND

  • Oravsky M, Bak V, Schnorrer M. Laparoscopic versus open appendectomy in treatment of acute appendicitis. Bratisl Lek Listy. 2014;115(10):660-2. doi: 10.4149/bll_2014_127.

    PMID: 25573735BACKGROUND

  • Palmes D, Rottgermann 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. doi: 10.1002/bjs.5810.

    PMID: 17571296BACKGROUND

  • Reynolds SL, Jaffe DM. Diagnosing abdominal pain in a pediatric emergency department. Pediatr Emerg Care. 1992 Jun;8(3):126-8. doi: 10.1097/00006565-199206000-00003.

    PMID: 1614900BACKGROUND

  • 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.

    PMID: 8885946BACKGROUND

  • 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.

    PMID: 23057502BACKGROUND

  • 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.

    PMID: 21958060BACKGROUND

  • Woolf CJ. Evidence for a central component of post-injury pain hypersensitivity. Nature. 1983 Dec 15-21;306(5944):686-8. doi: 10.1038/306686a0.

    PMID: 6656869BACKGROUND

  • 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. doi: 10.1002/bjs.1800800136.

    PMID: 8428267BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAppendicitisAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Raj Singhal, MD

CONTACT

rsinghal@valley.md

Vanessa Pohl, BS

CONTACT

6029334482vpohl@phoenixchildrens.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 29, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

May 2, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)