Temperature and Pain in Laparoscopy

NCT02781194 | Completed DMC

• 1 other identifier: 13-030
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Intra-operative core temperature

  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

  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

  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)

  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)

  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

  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

Study Arms (3)

forced-air warming blanket

EXPERIMENTAL

Forced-air warming blanket via 3M™ Bair Hugger™.

Device: 3M™ Bair Hugger™

warmed, humidified insufflation

EXPERIMENTAL

Warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System.

Device: F&P HumiGard™ Surgical Humidification System

forced-air warming blanket & warmed, humidified insufflation

EXPERIMENTAL

Combination of forced-air warming blanket via 3M™ Bair Hugger™ and warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System.

Device: 3M™ Bair Hugger™; Device: F&P HumiGard™ Surgical Humidification System

Interventions

3M™ Bair Hugger™ DEVICE

forced-air warming blanket

forced-air warming blanket; forced-air warming blanket & warmed, humidified insufflation

F&P HumiGard™ Surgical Humidification System DEVICE

warmed, humidified insufflation

forced-air warming blanket & warmed, humidified insufflation; warmed, humidified insufflation

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (3)

• 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.

  RESULT

• 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.

  PMID: 35286431 DERIVED

• 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.

  PMID: 34596747 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Julia Wittenborn, Dr. med.

  Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 24, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 12, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)