Clinical trial NCT04949659: Low vs Medium Pressure Pneumoperitoneum
Official title: Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appendicitis Acute
Keywords: Pneumoperitoneum
Pressure
Pain
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 250
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.


Eligibility criteria: Inclusion Criteria:

* Prepped and consented for diagnostic laparoscopy for likely acute appendicitis
* 5 years or older
* 15 kg or more
* Parents/legal custodian give consent, patient shows no signs of unwillingness to participate
* Patient is hemodynamically stable

Exclusion Criteria:

* Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis
* Suspected perityphlitic abscess on preoperative ultrasound
* Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties
* Parents have inadequate knowledge of German language to understand Informed consent
* Child has inadequate knowledge of German language to allow elicitation of Pain Scores

Primary outcomes:
measure: Postoperative pain score on postoperative day one (abdominal pain)
timeFrame: Postoperative day one.
Secondary outcomes:
measure: Postoperative pain scores during postoperative phase (abdominal pain)
timeFrame: Through study completion, an average of 3 days
measure: Postoperative pain scores during postoperative phase (shoulder pain)
timeFrame: Through study completion, an average of 3 days
measure: Length of operation
timeFrame: Intraoperative
measure: Length of stay
timeFrame: Through study completion, an average of 3 days
measure: Intra- and postoperative complications
timeFrame: Through study completion, an average of 3 days
measure: Analgesic use
timeFrame: Through study completion, an average of 3 days
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
state: Zurich
Study officials:
affiliation: University Children's Hospital of Zurich
name: Hannah R Neeser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
citation: Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
citation: McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.