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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00372268
Enrollment
248
Registered
2006-09-06
Start date
2006-01-31
Completion date
2011-10-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Laparoscopy, Pain, Postoperative

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

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).

Interventions

DEVICEAeroneb® 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.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evolution of core temperatureFrom the beginning of the anesthetic procedure to the discharge of the recovery room.
Post-operative painFrom the arrival in the recovery room to the 6th post-operative day.

Secondary

MeasureTime frame
Inflammation parametersFrom 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 lifeFrom the discharge of the recovery room to the 6th post-operative day
Surgical comfortDuring the duration of the surgical procedure.

Countries

France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026