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Completed

NCT Number: NCT04949659

Low vs Medium Pressure Pneumoperitoneum

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.

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Key information

Conditions

Appendicitis Acute Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Peritoneal Diseases Pneumoperitoneum Signs and Symptoms

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic appendectomy

Procedure

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

Primary outcomes

  1. Postoperative pain score on postoperative day one (abdominal pain)

    Time frame: Postoperative day one.

    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.

Secondary outcomes

  1. Postoperative pain scores during postoperative phase (abdominal pain)

    Time frame: Through study completion, an average of 3 days

    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.

  2. Postoperative pain scores during postoperative phase (shoulder pain)

    Time frame: Through study completion, an average of 3 days

    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.

  3. Length of operation

    Time frame: Intraoperative

    Length of operation in minutes

  4. Length of stay

    Time frame: Through study completion, an average of 3 days

    Length of stay in hospital in hours

  5. Intra- and postoperative complications

    Time frame: Through study completion, an average of 3 days

    Intra- and postoperative complications during hospitalisation

  6. Analgesic use

    Time frame: Through study completion, an average of 3 days

    Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Acronym: LoMePneu

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2021
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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