Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
This study has been completed.
Sponsor:
University Hospital, Strasbourg, France
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
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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
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 May 23, 2013