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

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

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).

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Hypothermia; Laparoscopy
• Intervention / Treatment: Device: Aeroneb® Pro (Nektar® Company); Device: Aeroneb® Pro (Nektar® Company)

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Schiltigheim, France, 67300
    • Sihcus-Cmco
  • Strasbourg, France, 67098
    • Hôpital de HAUTEPIERRE
• Italy
  • Monza, Italy, 20051
    • Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: B; Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery	Device: Aeroneb® Pro (Nektar® Company); The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.; Device: Aeroneb® Pro (Nektar® Company); The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
ACTIVE_COMPARATOR: C; 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); The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.; Device: Aeroneb® Pro (Nektar® Company); The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
PLACEBO_COMPARATOR: A; 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); The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.; Device: Aeroneb® Pro (Nektar® Company); The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
PLACEBO_COMPARATOR: D; Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery	Device: Aeroneb® Pro (Nektar® Company); The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.; Device: Aeroneb® Pro (Nektar® Company); The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Pierre DIEMUNSCH, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: September 5, 2006
• First Submitted That Met QC Criteria: September 5, 2006
• First Posted (ESTIMATE): September 6, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): April 13, 2012
• Last Update Submitted That Met QC Criteria: April 12, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Body Temperature Changes; Pain, Postoperative; Hypothermia
• Other Study ID Numbers: 3621