Low vs Medium Pressure Pneumoperitoneum

Study Overview
=================
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.

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

Conditions
-----------------
Appendicitis Acute

Intervention / Treatment
-----------------
* Procedure: Laparoscopic appendectomy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low pressure pneumoperitoneum<br>Use of low pressure pneumoperitoneum during laparoscopic appendectomy | Procedure: Laparoscopic appendectomy<br>* Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum<br>|
| Experimental: Medium pressure pneumoperitoneum<br>Use of medium pressure pneumoperitoneum during laparoscopic appendectomy | Procedure: Laparoscopic appendectomy<br>* Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Length of operation | Length of operation in minutes | Intraoperative | 
| Length of stay | Length of stay in hospital in hours | Through study completion, an average of 3 days | 
| Intra- and postoperative complications | Intra- and postoperative complications during hospitalisation | Through study completion, an average of 3 days | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumoperitoneum, Pressure, Pain