Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy

Appendicitis Clinical Trial

— PAMAL  

Official title:

Comparative Retrospective Study on the Different Analgesic Modalities Used for Single-incision Laparoscopic Appendectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05773521
• Other study ID #: 2022-124
• Status: Not yet recruiting
• Start date: August 31, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Angers
• Contact: Jeanne Goulin, MD
• Phone: +33 2 41 35 42 90
• Email: jeanne.goulin[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• SILAP (single incision laparoscopic appendectomy)
Appendectomy performed through transumbilical single access laparoscopy, consisting in the removal of the appendix.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the level of pain after SILAP during the 24 first hours after surgery.	Objectified by the quantity of level 2-3 (in morphin equivalent) analgesic used up to 24 hours after surgery.	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	To assess the level of pain as measured by the different pain scales routinely used.	Objectified by the higher level of pain quoted during the first 24 hours after surgery.	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	To assess the level of pain during the initial post-operative recovery room stay.	Objectified by the higher level of pain quoted during the first 24 hours after surgery and by the amount of level 2-3 analgesic used.	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	To assess the level of pain after the 24 first hours and until hospital release.	Objectified by the higher level of pain quoted from 24 hours post-operative to hospital discharge, and by the amount of level 2-3 analgesic used.	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	To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.	Objectified by the amount of level 2-3 analgesics used in post-operative recovery room and during hospital stay.	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	To assess the types and gravity of peri-operative and post-analgesia complications.	Objectified by the description of complications encountered and classified with the Clavien and Dindo gravity scale for surgical complications.	Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age