NCT06016777

Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, randomized controlled study. Patients who are scheduled for elective uniportal thoracoscopic surgery in our hospital will be enrolled. Patients will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block, ultrasound-guided erector spinae block, or intravenous patient-controlled analgesia pump group. Different nerve block operation schemes will be used in different groups. In any of the three groups, general anesthesia will be performed according to the standard, and multi-mode analgesic treatment will be appied as the combination of NSAIDs analgesics, opioid analgesics, and postoperative rescue analgesic treatment. Participants will be followed up at 1, 4, 12, 18 hours, on 1, 2, 3, 4, 7 days, and in 1, 2, 3, 4, 6 months after surgery. At each follow-up visit, rest and cough pain level will be recorded, and sense of touch and pain in the chest will be examined. Additional analgesic treatment will be given if necessary. Comparisons of the postoperative analgesic use, cough and rest pain, ambulation time, length of hospital stay, and hospital costs will be made in the three groups.

Conditions

• Uniportal Video-assisted Thoracic Surgery

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump	Patients in this group will receive ultrasound-guided paraspinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage \<5μg/hour.
PROCEDURE	Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump	Patients in this group will receive ultrasound-guided erector spinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage \<5μg/hour.
PROCEDURE	Patient-controlled intravenous analgesia pump	Patients in this group will not receive regional block. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage \<5μg/hour.

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-09-30
• Completion: 2025-10-31
• First posted: 2023-08-30
• Last updated: 2024-01-29

Locations

1 site across 1 country: China