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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00372268
First received: September 5, 2006
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention
Laparoscopy
Pain, Postoperative
Hypothermia
Device: Aeroneb® Pro (Nektar® Company)
Device: Aeroneb® Pro (Nektar® Company)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Evolution of core temperature [ Time Frame: From the beginning of the anesthetic procedure to the discharge of the recovery room. ] [ Designated as safety issue: Yes ]
  • Post-operative pain [ Time Frame: From the arrival in the recovery room to the 6th post-operative day. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Inflammation parameters [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: From the discharge of the recovery room to the 6th post-operative day ] [ Designated as safety issue: No ]
  • Surgical comfort [ Time Frame: During the duration of the surgical procedure. ] [ Designated as safety issue: Yes ]

Enrollment: 248
Study Start Date: January 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
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.
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 dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372268

Locations
France
Sihcus-Cmco
Schiltigheim, France, 67300
Hôpital de Hautepierre
Strasbourg, France, 67098
Italy
Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL
Monza, Italy, 20051
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pierre DIEMUNSCH, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00372268     History of Changes
Other Study ID Numbers: 3621
Study First Received: September 5, 2006
Last Updated: April 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
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:
Hypothermia
Pain, Postoperative
Body Temperature Changes
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain

ClinicalTrials.gov processed this record on August 18, 2014