Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Trial design Despite video-assisted thoracic technology and procedure specific postoperative pain management (PROSPECT) have been promoted through recent years, thoracic surgery is still considered to be one of the most painful of surgical procedures. This study aims to optimize these conditions according to different perioperative analgesic modes recommended at present. This will be a single-blind randomized study to investigate the optimal analgesic effect of thoracic paravertebral block (TPB), erector spinae block (ESB), or sufentanil patient controlled intravenous analgesia (PCIA) for uniportal video-assisted thoracoscopic surgery (uVATS) and using minimally invasive drainage. Methods One-hundred and two patients undergoing uVATS will be enrolled. Patients will be randomly assigned to PVB group (20mL 0.3% ropivacaine with dexamethasone), ESB group (20mL 0.3% ropivacaine with dexamethasone) or CON group. PCIA with sufentanil will be provided to all patients after surgery. Primary outcome will be total opioid consumption from the end of the surgery to the time of discharge. Secondary outcomes consist of postoperative pain score, postoperative chronic pain, both at rest and during coughing, sensations of touch and pain on the chest wall, non-opioid analgesic drug use, length of stay (LOS), ambulation time, total cost of hospitalization and long-term postoperative analgesia. Adverse reaction to analgesics and adverse event related to regional block will also be recorded. Ethics and dissenmination This study is approved by the Ethics Committee of China-Japan Friendship Hospital (ID 2022-KY-127-1). The results will be published in peer-reviewed journals. Key words: fast-track; Enhanced Recovery After Surgery; uniportal video-assisted thoracoscopic surgery; randomized controlled trial; thoracoscopic; ultrasonic guidance; paravertebral block; erector spinal block

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years

• ASA I-IIa

• Early stage lung cancer or intrathoracic tissue biopsy, suitable for elective uVATSb

• Informed consent obtained

Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Li Fang WANG, Doctor
lilythewolf@sina.com
+8615011393879
Backup
Zhen Rong ZHANG, Doctor
doctor_zzr@126.com
+8613811000378
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 102
Treatments
Experimental: PVB+PCIA group
Experimental: ESB+PCIA group
Active_comparator: PCIA group
Related Therapeutic Areas
Sponsors
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov