Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis

NCT04717193 | Completed Phase 2 DMC

• 1 other identifier: RSB-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the pain control effects of a rectus sheath block after laparoscopic surgery to remove the appendix. A rectus sheath block is the injection of local anesthetic (numbing agent) into the space between the muscles of the belly wall. Children having surgery for appendicitis age 8-17 at the Stollery Children's Hospital will be eligible to participate. Patients with complicated appendicitis (perforation or abscess), chronic pain, bleeding disorders, or inability to document pain scores will be excluded from this study. Participants will be randomly assigned to either rectus sheath block or standard local anesthetic. The standard local anesthetic group will have local anesthetic (numbing agent) injected around their surgery cut sites. The rectus sheath block group will have this standard plus the rectus sheath block with local anesthetic. Participants, parents, anesthesiologists and nursing staff will not know which group the participant has been assigned to. The surgeon will know the group. The same pain and nausea medications will be ordered for all participants after the surgery. Pain scores will be measured using the Faces Pain Scale - Revised tool. Participants will be asked to rate their pain in the recovery room, in their hospital room at 3 and 6 hours after the surgery and again before going home. This tool has been shown to be useful for rating children's pain levels. The study will also measure the amount of pain and nausea medications that participants are given during their surgery and recovery. Participants will see their surgeon at 6 weeks after their surgery where they will be asked about any problems after being discharged home. Data will be analyzed with a linear mixed model.

Conditions

Appendicitis Acute

Outcome Measures

Primary Outcomes (1)

• Self-reported pain scores at 3 hours post-operatively

  Reported with Faces Pain Scale - Revised. Scale runs from 0-10 with 0 being no pain and 10 being the worst pain they have experienced.

  3 hours

Secondary Outcomes (4)

• Self-reported pain scores in recovery room, at 6 hours post-operatively, and prior to discharge home

  Immediately post-operatively to approximately 24 hours

• Intra-operative narcotic use in mg/kg morphine equivalents

  Intra-operative

• Post-operative narcotic use in mg/kg morphine equivalents

  Approximately 24 hours

• Post-operative anti-emetic use mg/kg or ondansetron and dimenhydrinate

  Approximately 24 hours

Study Arms (2)

Rectus Sheath Block

EXPERIMENTAL

Participants randomized to the experimental arm will receive a bilateral rectus sheath block which is additional to the standard of care (infiltration of 5mg (2mL) 0.25% bupivacaine with epinephrine around port site incisions). For rectus sheath block, use the formula Volume (ml) = 2mg/kg x weight (kg) divided by 2.5mg/ml - 6ml to a maximum of 14ml. Maximum total dose is 2mg/kg. Participants will be asked to rate their pain a total of 4 times for the study. Each occurrence is expected to take approximately 1-2 minutes to complete. There will be no additional follow-up required as part of the study. The 6 week follow-up visit is standard routine practice.

Drug: Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine

Local Anesthetic

ACTIVE COMPARATOR

Participants in the control arm will receive the standard care which is infiltration of 5mg (2mL) of 0.25% bupivacaine with epinephrine around port site incisions. Participants will be asked to rate their pain a total of 4 times for the study. Each occurrence is expected to take approximately 1-2 minutes to complete. There will be no additional follow-up required as part of the study. The 6 week follow-up visit is standard routine practice.

Procedure: Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine

Interventions

Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine DRUG

Bilateral rectus sheath block plus infiltration local anesthetic at incision sites.

Rectus Sheath Block

Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine PROCEDURE

Infiltration of local anesthetic at incision sites.

Local Anesthetic

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of acute uncomplicated appendicitis
• Age 8-17 years

You may not qualify if:

• Complicated appendicitis, perforation, abscess
• History of chronic pain condition or long-term analgesic use
• History of bleeding condition
• Condition preventing accurate documentation of post-operative pain scores using the FPS-R tool including severe developmental delay, psychiatric illness, or partially sighted or blindness
• Previous open abdominal surgery
• Presence of an abdominal prosthesis such as a gastrostomy tube or ventricular-peritoneal shunt device
• Allergy to bupivacaine or morphine

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

Related Publications (4)

• Dingeman RS, Barus LM, Chung HK, Clendenin DJ, Lee CS, Tracy S, Johnson VM, Dennett KV, Zurakowski D, Chen C. Ultrasonography-guided bilateral rectus sheath block vs local anesthetic infiltration after pediatric umbilical hernia repair: a prospective randomized clinical trial. JAMA Surg. 2013 Aug;148(8):707-13. doi: 10.1001/jamasurg.2013.1442.

  PMID: 23760519 BACKGROUND

• 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: 21958060 RESULT

• Hamill JK, Liley A, Hill AG. Rectus sheath block for laparoscopic appendicectomy: a randomized clinical trial. ANZ J Surg. 2015 Dec;85(12):951-6. doi: 10.1111/ans.12950. Epub 2015 Jan 12.

  PMID: 25581711 RESULT

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Troy Perry, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single-blind. Surgeon cannot be blinded to the intervention. Anesthesiologist, participants, parents, and nursing staff in the OR, recovery room, and ward will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 22, 2021
• Study Start: May 28, 2021
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)