Clinical trial NCT05773521: Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy
Official title: Comparative Retrospective Study on the Different Analgesic Modalities Used for Single-incision Laparoscopic Appendectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Appendicitis
Keywords: appendectomy
single-site laparoscopy
analgesia
pain
peri-operative management
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-03-17
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients operated on by single-site access for laparoscopic appendectomy.

Brief summary: Laparoscopic appendectomy is a very common intervention in pediatric surgery. To improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (SILAP). Nevertheless, there is no consensus yet and no published data on the better perioperative analgesia, and different modalities including general intravenous analgesia, locoregional pre-operative analgesia and local analgesia can be used.

Detailed description: The aim of this retrospective study is to describe the different types of perioperative analgesia routinely used and to compare them to determine the more efficient one for early postoperative pain relief.

Eligibility criteria: Inclusion Criteria:

* All patients operated on for appendectomy by SILAP, aged 15 years and under in our pediatric surgical center.

Exclusion Criteria:

* Patients aged 16 years or more.
* Patients with concomitant pathologies potentially inducing hyper- or hypoesthesia (e.g. cancers, spinal cord injury, etc...)
* Patients with contraindications for the use of IV analgesics.
* patients operated on for appendectomy through 3-ports laparoscopy or open surgery.
* Opposition of the patients and their representative to the study.

Primary outcomes:
measure: To assess the level of pain after SILAP during the 24 first hours after surgery.
timeFrame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
Secondary outcomes:
measure: To assess the level of pain as measured by the different pain scales routinely used.
timeFrame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
measure: To assess the level of pain during the initial post-operative recovery room stay.
timeFrame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
measure: To assess the level of pain after the 24 first hours and until hospital release.
timeFrame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
measure: To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.
timeFrame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
measure: To assess the types and gravity of peri-operative and post-analgesia complications.
timeFrame: Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: University hospital of Angers
name: Françoise Schmitt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goodman LF, Lin AC, Sacks MA, McRae JJLH, Radulescu A, Khan FA. Single site versus conventional laparoscopic appendectomy: some pain for no gain? J Surg Res. 2021 Aug;264:321-326. doi: 10.1016/j.jss.2021.03.010. Epub 2021 Apr 10.
citation: Binet A, Braik K, Lengelle F, Laffon M, Lardy H, Amar S. Laparoscopic one port appendectomy: Evaluation in pediatric surgery. J Pediatr Surg. 2018 Nov;53(11):2322-2325. doi: 10.1016/j.jpedsurg.2017.12.018. Epub 2017 Dec 27.