Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery
- Conditions
- Uniportal Video-assisted Thoracic Surgery
- Interventions
- Procedure: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pumpProcedure: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pumpProcedure: Patient-controlled intravenous analgesia pump
- Registration Number
- NCT06016777
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
- ≥18 years
- ASA I-IIa
- Early stage lung cancer or intrathoracic tissue biopsy, suitable for elective uVATSb
- Informed consent obtained
- ASA≥III
- History of intrathoracic or chest wall surgery
- Chronic pain
- Pre-operative analgesic medication use
- NSAIDsc contraindications: aspirin asthma, allergic to NSAIDs, peptic ulcer, liver and kidney insufficiency, high risk of thrombotic events
- Active autoimmune disease
- Allergic to local anesthetics
- Severe coagulation dysfunction, contraindicated for nerve block
- Soft tissue infections of the chest wall
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESB+PCIA group Patient-controlled intravenous analgesia pump - PCIA group Patient-controlled intravenous analgesia pump - PVB+PCIA group Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump - ESB+PCIA group Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump - PVB+PCIA group Patient-controlled intravenous analgesia pump -
- Primary Outcome Measures
Name Time Method total opioid consumption up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy. total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.
- Secondary Outcome Measures
Name Time Method chest tube removal time from the time at the end of surgery to 24 weeks after surgery The time from surgery to removal of the chest drainage tube
non-opioid analgesic drug use from the time at the end of surgery to 24 weeks after surgery number of patients with long-term (≥3 days) use of non-opioid analgesic drug
length of stay (LOS) up to 1 month, LOS is the amount of days the patient spends in the hospital, determined by subtracting the date of admission from the date of discharge days of hospital stay
ambulation time up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure first time of successful activity off bed, the time between the end of surgery to the time of the first successful ambulation
postoperative pain score assessed by Numeric Rating Scales, NRS (1-10) from the time at the end of surgery to 24 weeks after surgery rest and cough pain
long-term postoperative analgesia from the time at the end of surgery to 24 weeks after surgery number of patient who needs long-term postoperative analgesia (≥3 days after discharge)
postoperative pain score assessed by Visual Analogue Scale VAS (1-10) from the time at the end of surgery to 24 weeks after surgery rest and cough pain
sensations of touch on the chest wall from the time at the end of surgery to 24 weeks after surgery difference in tactile sense on bilateral chest-wall. Tactile sensation and cold sensation will be measured at four points (\<3cm near the incision, and on the other side on the symmetrical chest wall, and at the point of bilateral mid-clavicular-costal arch) with an alcohol-stained cotton swab
adverse events from the time at the end of surgery to 24 weeks after surgery Adverse reactions such as dizziness, nausea, vomiting, drowsiness, dyspnea, fatigue, constipation and urinary retention were recorded in detail
total cost of hospitalization up to 1 month, total charges settled on the day of discharge the in-patients costs total cost of hospitalization=medication cost + hospitalization cost + nursing cost + delay compensation
Trial Locations
- Locations (1)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China