Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Laparoscopy; Pain, Postoperative; Hypothermia

• Registration Number: NCT00372268
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.

The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:

* CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl

* CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl

* CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%

* CO2 dry and cold with direct intra-abdominal administration of Nacl

The investigators use a new device (Aeroneb® Pro \[Aerogen® Company\]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-01
• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-06
• Primary Completion: 2011-10
• Study Completion: 2011-10-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 248

Inclusion Criteria

• Womb surgery by laparoscopy
• Female
• Aged over 18 years
• No emergency

Exclusion Criteria

• Laparotomy
• Protocol rejected by the patient
• Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evolution of core temperature	From the beginning of the anesthetic procedure to the discharge of the recovery room.
Post-operative pain	From the arrival in the recovery room to the 6th post-operative day.

Secondary Outcome Measures

Name	Time	Method
Inflammation parameters	From the beginning of the anesthetic procedure to the end of the surgical procedure (one blood sample is done before the surgery, the second is done just after the arrival in the recovery room)
Quality of life	From the discharge of the recovery room to the 6th post-operative day
Surgical comfort	During the duration of the surgical procedure.

Trial Locations

Locations (3)

Sihcus-Cmco; 🇫🇷 Schiltigheim, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL; 🇮🇹 Monza, Italy