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

NCT00372268 | Completed

• 1 other identifier: 3621
• Study Type: interventional
• Target: 248
• Locations: 2 countries
• Sites: 3

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).

Conditions

Laparoscopy; Pain, Postoperative; Hypothermia

Keywords

Comparison of four conditionings of the insufflated gas during laparoscopy and their consequences on the core temperature and the post-operative pain.; Women with womb pathology needing laparoscopic surgery; No emergency; Aged over 18 years

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Study Arms (4)

B

ACTIVE COMPARATOR

Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery

Device: Aeroneb® Pro (Nektar® Company)

C

ACTIVE COMPARATOR

Administration of ropivacaïne 0,75% by nebulization in the insufflated gas during all the surgical procedure with direct intra-abdominal administration of Nacl 0,9%

Device: Aeroneb® Pro (Nektar® Company)

A

PLACEBO COMPARATOR

Administration of Nacl 0,9% by nebulization in the insufflated gas during all the surgical procedure with direct intra-abdominal administration of Nacl 0,9%

Device: Aeroneb® Pro (Nektar® Company)

D

PLACEBO COMPARATOR

Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery

Device: Aeroneb® Pro (Nektar® Company)

Interventions

Aeroneb® Pro (Nektar® Company) DEVICE

The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.

A; C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (3)

Sihcus-Cmco

Schiltigheim, 67300, France

Location

Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL

Monza, 20051, Italy

Location

Related Publications (1)

• Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c.

  PMID: 18633034 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Hypothermia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Body Temperature Changes

Study Officials

• Pierre DIEMUNSCH, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 6, 2006
• Study Start: January 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

IT (1); FR (2)