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

Primary Purpose

Laparoscopy, Pain, Postoperative, Hypothermia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Aeroneb® Pro (Nektar® Company)
Aeroneb® Pro (Nektar® Company)
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparoscopy focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sihcus-Cmco
  • Hôpital de Hautepierre
  • Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

B

C

A

D

Arm Description

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

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%

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%

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

Outcomes

Primary Outcome Measures

Evolution of core temperature
Post-operative pain

Secondary Outcome Measures

Inflammation parameters
Quality of life
Surgical comfort

Full Information

First Posted
September 5, 2006
Last Updated
April 12, 2012
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT00372268
Brief Title
Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
Official Title
Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Description
Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery
Arm Title
C
Arm Type
Active Comparator
Arm Description
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%
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
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%
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery
Intervention Type
Device
Intervention Name(s)
Aeroneb® Pro (Nektar® Company)
Intervention Description
The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.
Intervention Type
Device
Intervention Name(s)
Aeroneb® Pro (Nektar® Company)
Intervention Description
The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
Primary Outcome Measure Information:
Title
Evolution of core temperature
Time Frame
From the beginning of the anesthetic procedure to the discharge of the recovery room.
Title
Post-operative pain
Time Frame
From the arrival in the recovery room to the 6th post-operative day.
Secondary Outcome Measure Information:
Title
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)
Title
Quality of life
Time Frame
From the discharge of the recovery room to the 6th post-operative day
Title
Surgical comfort
Time Frame
During the duration of the surgical procedure.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre DIEMUNSCH, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sihcus-Cmco
City
Schiltigheim
ZIP/Postal Code
67300
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL
City
Monza
ZIP/Postal Code
20051
Country
Italy

12. IPD Sharing Statement

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

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