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Temperature and Pain in Laparoscopy

NCT02781194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-02-12

No results posted yet for this study

Summary

The aim of this investigation is to assess the impact of forced air warming, warm humidified insufflation gas and the combination of the two on intraoperative temperature maintenance and the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid following laparoscopic procedures (duration \> 60 min) in a prospective, randomized, controlled, mono-centric study. Therefore 150 subjects will be randomized in 3 groups of 50 subjects each. First group will be treated with forced-air warming blanket (bair hugger). Second group will be treated with warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. Third group will be treated with both, warming blankets and warmed, humidified insufflation. The peri-operative temperature of patients might be higher in patients of the third group with the combination of both treatments. The investigators hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage will differ between groups. Wound infection incidence and time spent in PACU are also expected to differ. Fibrinolytic activity in the peritoneal fluid is expected to be higher in patients undergoing laparoscopic procedures with humidified gas insufflation, since the trauma to the peritoneum will be less.

Conditions

  • Intraoperative Temperature
  • Postoperative Pain
  • Laparoscopy

Interventions

DEVICE

3M™ Bair Hugger™

forced-air warming blanket

DEVICE

F&P HumiGard™ Surgical Humidification System

warmed, humidified insufflation

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Julia Wittenborn, Dr. med. · Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781194 on ClinicalTrials.gov