- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02781194
Temperature and Pain in Laparoscopy (TePaLa)
A Prospective, Randomized, Controlled, Study Investigating Intraoperative Temperature and Postoperative Pain Course Following Gynaecological Laparoscopy
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
2 hours
|
Body temperature
Time Frame: 2 hours
|
Body temperature as measured by direct tympanic thermometer:
|
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
Sponsor
Investigators
- Principal Investigator: Julia Wittenborn, Dr. med., Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin
Publications and helpful links
General Publications
- 1. Frank S, Fleisher L, Breslow M, et al. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial [see comments]. JAMA 1997; 277(14):1127-34. -- 2. Frank S, Higgins M, Fleisher L, et al. Adrenergic, respiratory, and cardiovascular effects of core cooling in humans. Am J Physiol 1997; 272(2 Pt 2):R557-62. -- 3. Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. New England Journal of Medicine 1996; 334(19):1209-1215. -- 4. Hofer CK, Worn M, Tavakoli R, et al. Influence of body core temperature on blood loss and transfusion requirements during off-pump coronary artery bypass grafting: a comparison of 3 warming systems. J Thorac Cardiovasc Surg 2005; 129(4):838-43. -- 5. Johansson T, Lisander B, Ivarsson I. Mild hypothermia does not increase blood loss during total hip arthroplasty. Acta Anaesthesiol Scand 1999; 43(10):1005-10. -- 6. Melling AC, Ali B, Scott EM, Leaper DJ. Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial.[see comment][erratum appears in Lancet 2002 Mar 9;359(9309):896]. Lancet 2001; 358(9285):876-80. -- 7. Nesher N, Zisman E, Wolf T, et al. Strict thermoregulation attenuates myocardial injury during coronary artery bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg 2003; 96(2):328-35, table of contents. -- 8. Persson K, Lundberg J. Perioperative hypothermia and postoperative opioid requirements. Eur J Anaesthesiol 2001; 18(10):679-86. -- 9. Schmied H, Kurz A, Sessler DI, et al. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet 1996; 347(8997):289-92. -- 10. Sellden E. Peri-operative amino acid administration and the metabolic response to surgery. Proc Nutr Soc 2002; 61(3):337-43.
- Wittenborn J, Mathei D, van Waesberghe J, Zeppernick F, Zeppernick M, Tchaikovski S, Kowark A, Breuer M, Keszei A, Stickeler E, Zoremba N, Rossaint R, Bruells C, Meinhold-Heerlein I. The effect of warm and humidified gas insufflation in gynecological laparoscopy on maintenance of body temperature: a prospective randomized controlled multi-arm trial. Arch Gynecol Obstet. 2022 Sep;306(3):753-767. doi: 10.1007/s00404-022-06499-z. Epub 2022 Mar 14.
- Breuer M, Wittenborn J, Rossaint R, Van Waesberghe J, Kowark A, Mathei D, Keszei A, Tchaikovski S, Zeppernick M, Zeppernick F, Stickeler E, Zoremba N, Meinhold-Heerlein I, Bruells C. Warm and humidified insufflation gas during gynecologic laparoscopic surgery reduces postoperative pain in predisposed patients-a randomized, controlled multi-arm trial. Surg Endosc. 2022 Jun;36(6):4154-4170. doi: 10.1007/s00464-021-08742-1. Epub 2021 Oct 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on 3M™ Bair Hugger™
-
Universidade Estadual de LondrinaUniversity of Sao PauloUnknown
-
University of Missouri-ColumbiaTerminatedTemperature Change, BodyUnited States
-
Parc de Salut MarRecruitingHypothermia; Anesthesia | Temperature Change, BodySpain
-
Ajou University School of MedicineCompletedAnesthesia | Children, Only | Temperature Change, BodyKorea, Republic of
-
University of MinnesotaRecruitingTemperature Change, BodyUnited States
-
RECIO PÉREZ, JESÚSUniversity of AlcalaCompletedHypothermia; Anesthesia | Hypothermia Following Anesthesia | Hypothermia Following Anesthesia, Sequela | Hypothermia Due to AnestheticSpain
-
Nelson WoloskerCompleted
-
Peking Union Medical College Hospital3MUnknownBlood Coagulation Disorders | Hypothermia | Blood Loss,China
-
Seoul National University HospitalCompletedCore Body TemperatureKorea, Republic of
-
Fox Valley Orthopedic InstituteCompletedHypothermiaUnited States