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Laparoscopic AppendectomyNCT06945263

Comparing Pain Relief Between Two Methods of Freezing Injections in Children Having Their Appendix Removed

A study testing Rectus Sheath Block, Local Anesthetic at the Umbilical Port Site and Intravenous Dexamethasone in people with Laparoscopic Appendectomy, run by University of British Columbia at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Laparoscopic appendectomies are the most common emergency surgeries performed in children. Despite being considered minimally invasive surgeries, they can result in substantial postoperative pain and 2 of 3 patients require postoperative opioids. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Laparoscopic Appendectomy
What is being tested?
Rectus Sheath Block, Local Anesthetic at the Umbilical Port Site and Intravenous Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
1 May 2025to 27 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 4-18 years old
  • Diagnosed with acute appendicitis.
  • Undergoing a laparoscopic appendectomy

Who cannot join

  • Perforated/complicated appendicitis diagnosis
  • Previous abdominal surgery
  • Allergy to bupivacaine or dexamethasone
  • Severe developmental delay preventing patients from using pain scales or adequately communicating pain
  • Patients with Type 1 or 2 diabetes mellitus
  • Patients with steroid dependence

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

Official title: Rectus Sheath Block and Coadministration of Intravenous Dexamethasone for Analgesia After Pediatric Laparoscopic Appendectomy - A Pilot Study

Laparoscopic appendectomies are the most common emergency surgeries performed in children. Despite being considered minimally invasive surgeries, they can result in substantial postoperative pain and 2 of 3 patients require postoperative opioids. Increased postoperative pain can delay recovery, increase hospital admission time, lead to chronic pain, and cause patient distress. This study aims to reduce postoperative pain in this population by comparing the recovery outcomes associated with the administration of (1) an RSB with coadministration of IV dexamethasone as an LA adjunct (RSB+dex group) prior to the incision with (2) LA infiltration alone by the surgeon (LA group).

Being tested
Rectus Sheath Block, Local Anesthetic at the Umbilical Port Site, Intravenous Dexamethasone, Local Anesthetic at the Incision Site
Keywords
Rectus Sheath Block, Dexamethasone, Laparoscopic Appendectomy, Analgesia, Anesthesia, Local Anesthetic
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rectus Sheath BlockProcedure or surgery

    Bilateral rectus sheath blocks using an in-plane ultrasound-guided technique with 0.25% bupivacaine with epinephrine 1:200 000 at 0.8 mL/kg (half of total volume per side) up to a maximum of 20 mL prior to the incision.

  • Local Anesthetic at the Umbilical Port SiteDrug

    0.25% bupivacaine with epinephrine 1:200 000. Total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site.

  • Intravenous DexamethasoneDrug

    Intravenous Dexamethasone delivered concurrent to the RSB. Total dose of 150 mcg/kg up to a maximum of 8 mg.

  • Local Anesthetic at the Incision SiteDrug

    The remaining volume of local anesthetic (0.2 mL/kg) can be infiltrated at each of the incision sites at the discretion of the surgeon up to a maximum of 10 mL.

Study groups in NCT06945263
Study groupRoleWhat they receive
Rectus Sheath Block with Intravenous DexamethasoneExperimentalThe rectus sheath block (RSB) is already current standard of care for laparoscopic appendectomy patients and is used by providers at the British Columbia Children's Hospital. The RSB group will receive up to a maximum of 1 mL/kg total of local anesthetic, which will ensure the total volume calculation for each arm will receive a bupivacaine dose at or below 2.5 mg/kg body weight. The anesthesia team will perform the bilateral RSBs using an in-plane ultrasound-guided technique with 0.25% bupivacaine with epinephrine 1:200 000 at 0.8 mL/kg (half of total volume per side) up to a maximum of 20 mL prior to the incision. The surgical team will then use the remaining 0.2 mL/kg to infiltrate the remaining port sites in RSB groups. Intravenous Dexamethasone will be administered concurrently.
Receives: Procedure: Rectus Sheath Block; Drug: Intravenous Dexamethasone; Drug: Local Anesthetic at the Incision Site
Local AnestheticActive comparatorLocal anesthetic at the incision site is also current standard of care for appendectomy patients and is used by providers at the British Columbia Children's Hospital. This group will receive up to a maximum of 1 mL/kg total of LA which will ensure the total volume calculation for each arm would receive a bupivacaine dose at or below 2.5 mg/kg body weight. The local anesthetic infiltration arm will receive the same local anesthetic as the rectus sheath block arm (0.25% bupivacaine with epinephrine 1:200 000), injected by the surgeon. Surgeons can inject up to a total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site. The remaining volume of local anesthetic (0.2 mL/kg) can be infiltrated at each of the incision sites at the discretion of the surgeon.
Receives: Drug: Local Anesthetic at the Umbilical Port Site; Drug: Local Anesthetic at the Incision Site

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total opioid administration

    Continuous variable measured by collecting and totaling all opioid (excluding remifentanil) administrations from intraoperative, anesthetic care unit (ACU), and ward records and converting to morphine milligram per kilogram equivalents.

    Measured: From the start of surgery until up to 16 hours post-operatively.

Secondary outcomes (10)
  1. Mean postoperative pain score at 12 hours

    Discrete variable measured via age-appropriate visual analog scale (Faces Pain Scale-Revised) for participants who are younger than 12 years old. The Faces Pain Scale is on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

    Measured: 12 hours postoperatively

  2. Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively

    Discrete variable measured via age-appropriate visual analog scale (FACES Pain Scale-Revised) for participants who are younger than 12 years old. The Faces Pain Scale is on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

    Measured: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.

  3. Time spent performing rectus sheath block

    Time performing the rectus sheath block in minutes as recorded by the anesthesiologist.

    Measured: Intraoperatively.

  4. Duration of anesthesia care unit (ACU) stay

    Time between ACU admission and discharge.

    Measured: Perioperatively.

  5. Duration of post-procedural hospitalization

    Duration from entering the operating room to hospital discharge in minutes.

    Measured: Baseline (upon entering the operating room) to discharge from hospital, an average of 16 hours.

  6. Parental perspective on patient postoperative pain

    Parental assessment of patient postoperative pain using a numeric rating scale. The scale is from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

    Measured: 24 to 72 hours postoperatively

  7. Non-prescription postoperative drugs

    Which non-prescription drugs are administered post-operatively from the parent to the patient.

    Measured: 24 to 72 hours postoperatively

  8. Parental satisfaction with recovery

    Discrete 5-point scale (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) measuring parental satisfaction with patient recovery. Very unsatisfied is the worse outcome, very satisfied is the best outcome.

    Measured: 24 to 72 hours postoperatively.

  9. Mean Postoperative Pain Score at 12 Hours

    Discrete variable measured via age-appropriate scale (Numeric Rating Scale) for participants who are 12 years old or older. The numeric rating scale is from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

    Measured: 12 hours postoperatively

  10. Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively

    Discrete variable measured via age-appropriate scale (Numeric Rating Scale) for participants who are 12 years old or older. The numeric rating scale is from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

    Measured: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start1 May 2025
  3. Primary completion27 Apr 2026 (estimated)
  4. Study completion27 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06945263
Sponsor's protocol ID
H23-03547
Other IDs
F23-05308
Status last verified
May 2025
First submitted
3 Apr 2025
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pearson AME, Roberts S, Turbitt LR. New blocks on the kids: core basic nerve blocks in paediatric anaesthesia. Anaesthesia. 2023 Jan;78(1):3-8. doi: 10.1111/anae.15876. Epub 2022 Oct 11. No abstract available.

    PubMed 36220155
  • Shafy SZ, Miller R, Uffman JC, Tobias JD, Fetzer M, Nordin AB, Kenney B, Walia H, Veneziano G. An Enhanced Recovery Protocol that Facilitates Same-day Discharge for Simple Laparoscopic Appendectomies. Pediatr Qual Saf. 2019 Dec 5;4(6):e243. doi: 10.1097/pq9.0000000000000243. eCollection 2019 Nov-Dec.

    PubMed 32010869
  • Gee K, Ngo S, Burkhalter L, Beres AL. Safety and feasibility of same-day discharge for uncomplicated appendicitis: A prospective cohort study. J Pediatr Surg. 2018 May;53(5):988-990. doi: 10.1016/j.jpedsurg.2018.02.031. Epub 2018 Feb 9.

    PubMed 29510871
  • Cairo SB, Raval MV, Browne M, Meyers H, Rothstein DH. Association of Same-Day Discharge With Hospital Readmission After Appendectomy in Pediatric Patients. JAMA Surg. 2017 Dec 1;152(12):1106-1112. doi: 10.1001/jamasurg.2017.2221.

    PubMed 28678998
  • Alkhoury F, Burnweit C, Malvezzi L, Knight C, Diana J, Pasaron R, Mora J, Nazarey P, Aserlind A, Stylianos S. A prospective study of safety and satisfaction with same-day discharge after laparoscopic appendectomy for acute appendicitis. J Pediatr Surg. 2012 Feb;47(2):313-6. doi: 10.1016/j.jpedsurg.2011.11.024.

    PubMed 22325382
  • Cheng O, Cheng L, Burjonrappa S. Facilitating factors in same-day discharge after pediatric laparoscopic appendectomy. J Surg Res. 2018 Sep;229:145-149. doi: 10.1016/j.jss.2018.03.072. Epub 2018 Apr 25.

    PubMed 29936981
  • Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

    PubMed 29121400
  • Edinoff AN, Houk GM, Patil S, Bangalore Siddaiah H, Kaye AJ, Iyengar PS, Cornett EM, Imani F, Mahmoudi K, Kaye AM, Urman RD, Kaye AD. Adjuvant Drugs for Peripheral Nerve Blocks: The Role of Alpha-2 Agonists, Dexamethasone, Midazolam, and Non-steroidal Anti-inflammatory Drugs. Anesth Pain Med. 2021 Jul 4;11(3):e117197. doi: 10.5812/aapm.117197. eCollection 2021 Jun.

    PubMed 34540647
  • Desai N, Albrecht E. Local anaesthetic adjuncts for peripheral nerve blockade. Curr Opin Anaesthesiol. 2023 Oct 1;36(5):533-540. doi: 10.1097/ACO.0000000000001272. Epub 2023 Jun 14.

    PubMed 37314172
  • Maloney C, Kallis M, El-Shafy IA, Lipskar AM, Hagen J, Kars M. Ultrasound-guided bilateral rectus sheath block vs. conventional local analgesia in single port laparoscopic appendectomy for children with nonperforated appendicitis. J Pediatr Surg. 2018 Mar;53(3):431-436. doi: 10.1016/j.jpedsurg.2017.05.027. Epub 2017 Jun 2.

    PubMed 28610706
  • 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.

    PubMed 25581711
  • Hamill JK, Rahiri JL, Liley A, Hill AG. Rectus sheath and transversus abdominis plane blocks in children: a systematic review and meta-analysis of randomized trials. Paediatr Anaesth. 2016 Apr;26(4):363-71. doi: 10.1111/pan.12855. Epub 2016 Feb 4.

    PubMed 26846889
  • Russell P, von Ungern-Sternberg BS, Schug SA. Perioperative analgesia in pediatric surgery. Curr Opin Anaesthesiol. 2013 Aug;26(4):420-7. doi: 10.1097/ACO.0b013e3283625cc8.

    PubMed 23756911
  • Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available.

    PubMed 21895855
  • Yu TC, Hamill JK, Liley A, Hill AG. Warm, humidified carbon dioxide gas insufflation for laparoscopic appendicectomy in children: a double-blinded randomized controlled trial. Ann Surg. 2013 Jan;257(1):44-53. doi: 10.1097/SLA.0b013e31825f0721.

    PubMed 22824858

Questions about this trial

What is this clinical trial studying?

A study testing Rectus Sheath Block, Local Anesthetic at the Umbilical Port Site and Intravenous Dexamethasone in people with Laparoscopic Appendectomy, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total opioid administration (time frame: From the start of surgery until up to 16 hours post-operatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06945263, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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