Temperature and Pain in Laparoscopy (TePaLa)

February 11, 2019 updated by: RWTH Aachen University

A Prospective, Randomized, Controlled, Study Investigating Intraoperative Temperature and Postoperative Pain Course Following Gynaecological Laparoscopy

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.

Study Overview

Detailed Description

During the first 30 to 40 minutes of anaesthesia, a patient's temperature can drop to below 35.0°C. Reasons for this include loss of the behavioural response to cold and the impairment of thermoregulatory heat-preserving mechanisms under general or regional anaesthesia, anaesthesia-induced peripheral vasodilation, the use of cold dry insufflation gases. For these reasons, institutions employ a range of techniques to prevent hypothermia, including forced air warming (peri-operatively), use of warmed intravenous fluids, temperature monitoring and control of room temperature. Despite these interventions audits demonstrate that 20-56% of patients are hypothermic during the perioperative period. A factor often dismissed as a cause of peri-operative hypothermia during laparoscopic procedures is dry and cold insufflation gas. During laparoscopic procedures the abdomen is continuously insufflated with cold, dry CO2 resulting in desiccation and heat loss which consequently induces hypothermia in the patient. Clinical evidence suggests that the risk of hypothermia can be reduced using warm and humidified gas, as has been shown in animal models, in clinical trials and confirmed in a metaanalysis in humans. Only gas at body temperature and fully saturated with moisture will prevent loss of energy from the peritoneum surface - because it is physically not possible to evaporate fluids into a fully saturated gas. Therefore, the fluid layer will be maintained, minimizing energy loss from the body, decreasing the hypothermia induced by the evaporative losses in laparoscopic surgery and stabilizing the fibrinolytic activity of the peritoneum. 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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • NRW
      • Aachen, NRW, Germany, 52074
        • Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients aged 18 years or above and aged under 70 years
  • Written informed consent prior to study participation
  • Patients admitted to hospital for laparoscopic surgery with a planned duration of more than 1 hour; if there is an open component to the surgery then this should be discussed, in terms of the length of the laparoscopic component
  • BMI <35

Exclusion Criteria:

  • Pregnancy or women without sufficient contraception
  • Women, who are breastfeeding
  • Alcohol or drug abuse
  • Expected non-compliance
  • Patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
  • Participation on another interventional study within the last 3 months
  • Subjects who are committed to an institution and/or penitentiary by judicial or official order
  • Employees of the investigator cooperation companies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: forced-air warming blanket
Forced-air warming blanket via 3M™ Bair Hugger™.
forced-air warming blanket
Experimental: warmed, humidified insufflation
Warmed, humidified insufflation via the F&P HumiGard™ Surgical Humidification System.
warmed, humidified insufflation
Experimental: forced-air warming blanket & warmed, humidified insufflation
Combination of forced-air warming blanket via 3M™ Bair Hugger™ and warmed, humidified insufflation via the F&P HumiGard™ Surgical Humidification System.
forced-air warming blanket
warmed, humidified insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative core temperature
Time Frame: 2 hours

Intra-operative core temperature measured via oesophageal probe/urinary catheter after anaesthetic induction (baseline) but before insufflation and at 10 minute intervals until completion of surgery; hypothermia (<36 C) during the peri-operative period to be indicated by:

  • Mild (core temperature 35.0 °C to 35.9 °C)
  • Moderate (34.0 °C to 34.9 °C)
  • Severe ≤33.9 °C)
2 hours
Body temperature
Time Frame: 2 hours

Body temperature as measured by direct tympanic thermometer:

  • Pre-operatively - 1 hour before induction and at 10 minute intervals until induction
  • Before anesthetic induction
  • Post-operatively at entry to recovery room and at 10 minute intervals or until normo-thermia (≥36.5 °c) is achieved. Time at which normothermia is achieved to be recorded.
2 hours
VAS (visual analouge scale): composite measure of pain in different regions of the body
Time Frame: up to 7 days

VAS: Pain from abdominal area - Pain in the shoulder

- Pain on movement - Pain on coughing, before transfer to ward; at arrival in recovery room; 8 a.m. + 8 p.m. until discharge; 0 - 10 Numeric Pain Rating Scale by VAS, National Institute of Pain Control - NIPCTM

up to 7 days
morphine equivalent daily dose (MEDD) usage in patient controlled analgesia (PCA)
Time Frame: up to 7 days
MEDD usage: intraoperative, post anaesthesia care unit (PACU), Day 0, Day 1, Day 2, Day 3, Total during admission, Day on which PCA is removed if PCA is used. Start of PCA to be standardised, if possible all patient requests for PCA to be recorded by software, even if patient lockout has occurred due to too many attempts to activate PCA in a certain time.
up to 7 days
Perioperative Fluid (PV)
Time Frame: 2 hours
PV to be recorded at 10 min intervals perioperatively. Volume of electrolyte solution infused to be recorded, as well as time from induction until infusion takes place.
2 hours
Fibrinolytic activity
Time Frame: 2 days
Fibrinolytic activity in the peritoneal fluid will be determined at the beginning of surgery and Day 1. Sample will be taken from an abdominal drain.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julia Wittenborn, Dr. med., Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 13-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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