Impact of Perioperative Body Temperature on Postoperative Complications and Pain in Video-assisted Thoracoscopic Surgery Patients Utilizing Continuous Temperature Monitoring: A Prospective Cohort Study
Conditions: Lung Cancer (Diagnosis), Pain Management, Postoperative Complications, Body Temperature Measurement
Sponsor: Peking University People's Hospital

Study
Protocol:
Impact
of
perioperative
body
temperature on postoperative complications and pain
in
Video-assisted
thoracoscopic
surgery
patients
utilizing continuous temperature monitoring
Version 1.0
Document Date: Jun 20th 2025

1. Study Title
Impact of perioperative body temperature on postoperative complications and pain in
Video-assisted
thoracoscopic
surgery
patients
utilizing
a
continuous
temperature
monitoring System: A Prospective Cohort Study
2. Study Summary
2.1 Primary Objective
To investigate the impact of intraoperative hypothermia on postoperative complications
(e.g., infections, cardiopulmonary events, prolonged hospitalization) in Video-assisted
thoracoscopic surgery (VATS) patients.
2.2 Secondary Objective
To analyze the relationship between intraoperative hypothermia and the incidence of
moderate-to-severe postoperative pain.
3. Study Design
Type: Prospective cohort study
Exposure Group: Intraoperative hypothermia (body temperature <36.0°C for ≥30 min at
any time during surgery)
Non-Exposure Group: Body temperature consistently ≥36.0°C
Sample Size: 144 participants (72 per group; accounting for 10% dropout)
4. Participants
4.1 Inclusion Criteria:
- Age ≥18 years
- American society of anesthesiology (ASA) class I–III
- BMI 18.5–30 kg/m²
- Scheduled for VATS lung/mediastinal tumor resection (duration ≥1 hour)
- Receiving general anesthesia + regional block (TPVB + SAPB)
- Written informed consent
4.2 Exclusion Criteria:
- Preoperative fever (>37.5°C) or hypothermia (<36.0°C); ASA ≥IV
- Chronic opioid use (>3 months), chronic pain, or immunosuppression
- Emergency surgery or conversion to thoracotomy
- Planned surgery <1 hour or requiring cardiopulmonary bypass
- Failed regional block (sensory block not covering T2–T8 at 4h postoperation)
- Thyroid dysfunction or neurological disorders affecting pain assessment
5. Interventions/Monitoring
Temperature Monitoring: Wireless axillary sensor (non-surgical side), recorded every 5
minutes.
Hypothermia Management: Active warming (forced-air warmer + IV fluid warming) if
temperature <36.0°C for ≥30 min.

Regional Block: Ultrasound-guided TPVB + SAPB.
Postoperative Analgesia: PCA with oxycodone (no basal infusion; 5mg bolus, 10-min
lockout) + IV flurbiprofen (if no contraindication).
6. Outcome Measures
-
Primary
outcome:
Incidence
of
Clavien-Dindo
grade
≥
II
complications
(Daily clinical review until discharge)
- Secondary outcome: Moderate-severe pain (NRS ≥4) at 24h/48h/72h/post-discharge;
length of stay; ICU admission rate; 30-day readmission rate.
7. Follow-Up Schedule
Timepoint
Assessments
Endpoint Focus
Postop 6h
NRS pain
score;
Rescue
analgesia
Acute pain incidenc
Postop 24h/48h/72h
NRS
pain
score;
Complications;
Drain/ambulation
Pain
trajectory;
Early
complications
Discharge
Total LOS; Analgesia use
Hospitalization duration
Postop Day 7
Wound healing; Unplanned
visits
Wound complications
Postop Day 30
Complications; Chronic pain
(NRS≥3)
30-day morbidity; Persistent
pain
8. Statistical Analysis
- Primary Analysis: Multivariable logistic regression (hypothermia →complications),
Kaplan-Meier for time-to-event.
- Secondary Analysis:
- Logistic regression (hypothermia →pain), adjusted for regional block.
- Interaction testing ("hypothermia × block efficacy").
- Subgroup analysis by block success level.
- Software: R/Prism 8; Significance: p<0.05 (two-sided).
9. Ethics & Quality Control
- Ethics Approval: PKUPH IRB review prior to enrollment.
- Blinding: Outcome assessors masked to temperature group.
- Participant Protection: Voluntary withdrawal; anonymized data.
10. Timeline
- Preparation: Mar-May 2025 (IRB/registration/pilot)
- Enrollment: Jul 2025–Jun 2027
- Analysis: Jul-Aug 2027
- Publication: Dec 2027