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| ID | Type | Description | Link |
|---|---|---|---|
| F23-05308 | Other Grant/Funding Number | BC Children's Hospital Research Institute |
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| Name | Class |
|---|---|
| BC Children's Hospital Research Institute | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectus Sheath Block with Intravenous Dexamethasone | Experimental | The 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. |
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| Local Anesthetic | Active Comparator | Local 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectus Sheath Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of surgery until up to 16 hours post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prakash Krishnan, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36220155 | Background | 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. | |
| 32010869 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2024 |
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| Local Anesthetic at the Umbilical Port Site | Drug | 0.25% bupivacaine with epinephrine 1:200 000. Total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site. |
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| Intravenous Dexamethasone | Drug | Intravenous Dexamethasone delivered concurrent to the RSB. Total dose of 150 mcg/kg up to a maximum of 8 mg. |
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| Local Anesthetic at the Incision Site | Drug | 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. |
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| 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. |
| 0 hours, 4 hours, 8 hours, and 16 hours postoperatively. |
| Time spent performing rectus sheath block | Time performing the rectus sheath block in minutes as recorded by the anesthesiologist. | Intraoperatively. |
| Duration of anesthesia care unit (ACU) stay | Time between ACU admission and discharge. | Perioperatively. |
| Duration of post-procedural hospitalization | Duration from entering the operating room to hospital discharge in minutes. | Baseline (upon entering the operating room) to discharge from hospital, an average of 16 hours. |
| 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. | 24 to 72 hours postoperatively |
| Non-prescription postoperative drugs | Which non-prescription drugs are administered post-operatively from the parent to the patient. | 24 to 72 hours postoperatively |
| 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. | 24 to 72 hours postoperatively. |
| 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. | 12 hours postoperatively |
| 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. | 0 hours, 4 hours, 8 hours, and 16 hours postoperatively. |
| 29510871 | Background | 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. |
| 28678998 | Background | 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. |
| 22325382 | Background | 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. |
| 29936981 | Background | 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. |
| 29121400 | Background | 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. |
| 34540647 | Background | 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. |
| 37314172 | Background | 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. |
| 28610706 | Background | 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. |
| 25581711 | Background | 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. |
| 26846889 | Background | 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. |
| 23756911 | Background | 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. |
| 21895855 | Background | 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. |
| 22824858 | Background | 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. |
| 31326087 | Background | Shim H, Gan TJ. Side effect profiles of different opioids in the perioperative setting: are they different and can we reduce them? Br J Anaesth. 2019 Sep;123(3):266-268. doi: 10.1016/j.bja.2019.06.009. Epub 2019 Jul 17. No abstract available. |
| 21958060 | 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. |
| Feb 14, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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