Low vs Medium Pressure Pneumoperitoneum

Appendicitis Acute Clinical Trial

— LoMePneu  

Official title:

Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949659
• Other study ID #: 1001
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University Children's Hospital, Zurich
• Contact: Hannah R Neeser, MD
• Phone: +41442667045
• Email: Hannah.Neeser[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute
• Pneumoperitoneum

Intervention

Procedure:
• Laparoscopic appendectomy
Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain score on postoperative day one (abdominal pain)	Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.	Postoperative day one.
Secondary	Postoperative pain scores during postoperative phase (abdominal pain)	Postoperative pain score for abdominal pain on further postoperative days (excluding day one, which is primary outcome) after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.	Through study completion, an average of 3 days
Secondary	Postoperative pain scores during postoperative phase (shoulder pain)	Postoperative pain score for shoulder pain during hospitalisation after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.	Through study completion, an average of 3 days
Secondary	Length of operation	Length of operation in minutes	Intraoperative
Secondary	Length of stay	Length of stay in hospital in hours	Through study completion, an average of 3 days
Secondary	Intra- and postoperative complications	Intra- and postoperative complications during hospitalisation	Through study completion, an average of 3 days
Secondary	Analgesic use	Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses	Through study completion, an average of 3 days