Clinical trial NCT04938219: Shivering_Basel_Baden
Official title: Treatment of Intraoperative Shivering During Caesarean Section With Gloves Filled With Warm Water: a Multicentric, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shivering
Keywords: intraoperative shivering
caesarean section
neuraxial anaesthesia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women undergoing caesarean section under neuraxial anaesthesia will be randomised into either the treatment group or control group (2 arms).
Primary purpose: OTHER

Brief summary: Shivering is known to occur in around 40% of women as a side effect of neuraxial anaesthesia during caesarean section.Women undergoing caesarean section under neuraxial anaesthesia are randomised into either the treatment group or control group. Women in both groups are observed during caesarean section. This study is to test a non-pharmacological and non-invasive treatment with two groups, an intervention and a control group. In the intervention group, intraoperative shivering during caesarean section is treated by placing two surgical gloves filled with warm water into the women's hands. In the control group, women will be treated with the current standard of care, which does not include specific treatment of shivering.

Detailed description: Shivering is an involuntary, repetitive activity of skeletal muscles that often, but not exclusively, occurs as a thermoregulatory response to cold. It is associated with neuraxial anaesthesia and is therefore a commonly observed phenomenon during caesarean sections. The main cause for this is a sympathetic block of vasoconstriction in the legs, leading to cutaneous heat loss and lower core temperature. This is not always accompanied by a cold sensation, because the perceived skin temperature is increased. Out of all common side effects of neuraxial anaesthesia, shivering is perceived as the most uncomfortable and disruptive one. It can also interfere with monitoring of blood pressure, oxygen saturation and legibility of electrocardiograms. It increases the metabolic rate and oxygen consumption by up to 400%. Therefore, lactic acid and carbon dioxide production are significantly increased. Pregnant women have reduced cardiac and pulmonary reserves and may therefore have less capacity to adapt to the increased metabolic demands caused by shivering.

The incidence of shivering during caesarean section at the University Hospital Basel was determined by a previous study to be 41.0%. Studies have been conducted about pharmacological treatment options for intraoperative shivering during caesarean section. However, pharmacological treatment in pregnant and breastfeeding women is best reduced to a minimum.

This study is to test a non-pharmacological and non-invasive treatment with two groups, an intervention and a control group. In the intervention group, intraoperative shivering during caesarean section is treated by placing two surgical gloves filled with warm water into the women's hands. In the control group, women will be treated with the current standard of care, which does not include specific treatment of shivering. The warm water method has been used by doctors to reduce shivering, but the actual effects of it have never been scientifically proven. The gloves will be used as a treatment, not a prophylactic measure. Therefore, only the women who exhibit shivering during surgery will be treated.

Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent
* Age older than 18 years and younger than 40 years.
* Gestational age \>36 weeks
* Shivering during regional anaesthesia for caesarean section

Exclusion Criteria:

* Inability to give informed consent
* Latex allergy
* Receiving combined spinal epidural anaesthesia (CSEA)
* Secondary spinal anaesthesia for caesarean section in patients with unsatisfactory epidural labour analgesia

Primary outcomes:
measure: Change in intensity of shivering measured on a 5-point scale
timeFrame: at baseline, at 2 and 5 minutes after the first assessment, and in the post-anaesthesia recovery room (approx.1 hour)ent.
Secondary outcomes:
measure: Change in subjective comfort levels of the patients before and after the intervention on a 11-point scale
timeFrame: at baseline, at 2 and 5 minutes after the first assessment, and in the post-anaesthesia recovery room (approx.1 hour)
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden AG, Department of Anaesthesiology
state: Aargau
city: Basel
country: Switzerland
facility: University Hospital Basel; Department of Anaesthesiology
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Bigna Buddeberg, MD
role: PRINCIPAL_INVESTIGATOR
References: