LaparoscopyNCT00372268
Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
A study testing Aeroneb® Pro (Nektar® Company) in people with Laparoscopy and Pain, Postoperative, run by University Hospital, Strasbourg, France at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopy, Pain, Postoperative, Hypothermia
- What is being tested?
- Aeroneb® Pro (Nektar® Company)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2006to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Womb surgery by laparoscopy
- Female
- Aged over 18 years
- No emergency
Who cannot join
- Laparotomy
- Protocol rejected by the patient
- Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Sihcus-Cmco
Schiltigheim, 67300
Hôpital de Hautepierre
Strasbourg, 67098
Italy1 site
Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL
Monza, 20051
About this study
Official title: 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:
Read more
- 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
- Being tested
- Aeroneb® Pro (Nektar® Company)
- 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
- Medical subject headings
- Pain, Postoperative, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Aeroneb® Pro (Nektar® Company)Device
The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery Receives: 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% Receives: 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% Receives: Device: Aeroneb® Pro (Nektar® Company) |
| D | Placebo comparator | Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery Receives: Device: Aeroneb® Pro (Nektar® Company) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of core temperature
Measured: From the beginning of the anesthetic procedure to the discharge of the recovery room.
Post-operative pain
Measured: From the arrival in the recovery room to the 6th post-operative day.
Secondary outcomes (3)
Inflammation parameters
Measured: 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
Measured: From the discharge of the recovery room to the 6th post-operative day
Surgical comfort
Measured: During the duration of the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre DIEMUNSCH, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372268
- Sponsor's protocol ID
- 3621
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2006
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18633034
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT00372268
- Acronym / sponsor ID
- 3621
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Device: Aeroneb® Pro (Nektar® Company)Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery |
| C | Active comparator | Device: Aeroneb® Pro (Nektar® Company)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% |
| A | Placebo comparator | Device: Aeroneb® Pro (Nektar® Company)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% |
| D | Placebo comparator | Device: Aeroneb® Pro (Nektar® Company)Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Womb surgery by laparoscopy
- Female
- Aged over 18 years
- No emergency
Key exclusion criteria (3 listed)
- Laparotomy
- Protocol rejected by the patient
- Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | A, C |
| Aeroneb® Pro (Nektar® Company)The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure. | Device | B, D |
Primary outcome
Evolution of core temperature
Time frame: From the beginning of the anesthetic procedure to the discharge of the recovery room.
Post-operative pain
Time frame: From the arrival in the recovery room to the 6th post-operative day.
3 secondary outcomes
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)
Quality of life
Time frame: From the discharge of the recovery room to the 6th post-operative day
Surgical comfort
Time frame: During the duration of the surgical procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 18633034Greib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre DIEMUNSCH, MD principal investigator
Hôpitaux Universitaires de Strasbourg
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aeroneb® Pro (Nektar® Company) in people with Laparoscopy and Pain, Postoperative, run by University Hospital, Strasbourg, France at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of core temperature (time frame: From the beginning of the anesthetic procedure to the discharge of the recovery room.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00372268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.