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Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05773521
Acronym
PAMAL
Enrollment
140
Registered
2023-03-17
Start date
2023-08-31
Completion date
2023-12-31
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

Keywords

appendectomy, single-site laparoscopy, analgesia, pain, peri-operative management

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.

Interventions

PROCEDURESILAP (single incision laparoscopic appendectomy)

Appendectomy performed through transumbilical single access laparoscopy, consisting in the removal of the appendix.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 15 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To assess the level of pain after SILAP during the 24 first 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 ageObjectified by the quantity of level 2-3 (in morphin equivalent) analgesic used up to 24 hours after surgery.

Secondary

MeasureTime frameDescription
To assess the level of pain as measured by the different pain scales routinely used.Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of ageObjectified by the higher level of pain quoted during the first 24 hours after surgery.
To assess the level of pain during the initial post-operative recovery room stay.Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of ageObjectified by the higher level of pain quoted during the first 24 hours after surgery and by the amount of level 2-3 analgesic used.
To assess the level of pain after the 24 first hours and until hospital release.Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of ageObjectified 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.
To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of ageObjectified by the amount of level 2-3 analgesics used in post-operative recovery room and during hospital stay.
To assess the types and gravity of peri-operative and post-analgesia complications.Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of ageObjectified by the description of complications encountered and classified with the Clavien and Dindo gravity scale for surgical complications.

Countries

France

Contacts

Primary ContactJeanne Goulin, MD
jeanne.goulin@chu-angers.fr+33 2 41 35 42 90
Backup ContactFrançoise Schmitt, MD-PhD
FrSchmitt@chu-angers.fr+33 2 41 35 42 90

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026