Clinical trial NCT06016777: Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery
Official title: Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uniportal Video-assisted Thoracic Surgery
Keywords: fast-track
Enhanced Recovery After Surgery
uniportal video-assisted thoracoscopic surgery
randomized controlled trial
thoracoscopic; ultrasonic guidance
paravertebral block
erector spinal block
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a parallel-group, single-blind, randomized controlled trial. Patients are expected to be enrolled in the trial within 8 months. Participants will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block (PVB+PCIA group), ultrasound-guided erector spinae block(ESB+PCIA group) , or intravenous patient-controlled analgesia pump group (PCIA group). Different nerve block operation schemes will be used in different groups.Except for different nerve block schemes, all the participants will have the same methods and choices of medicine for other kinds of rescue analgesia regimens.The participants and the follow-up evaluation doctors are not aware of the group assignment, and the surgeon and anesthesiologist will not know the grouping code until the beginning of the surgery. In this way, the analgesic effect of each subject can be fairly evaluated.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years
2. ASA I-IIa
3. Early stage lung cancer or intrathoracic tissue biopsy, suitable for elective uVATSb
4. Informed consent obtained

Exclusion Criteria:

1. ASA≥III
2. History of intrathoracic or chest wall surgery
3. Chronic pain
4. Pre-operative analgesic medication use
5. NSAIDsc contraindications: aspirin asthma, allergic to NSAIDs, peptic ulcer, liver and kidney insufficiency, high risk of thrombotic events
6. Active autoimmune disease
7. Allergic to local anesthetics
8. Severe coagulation dysfunction, contraindicated for nerve block
9. Soft tissue infections of the chest wall

Primary outcomes:
measure: total opioid consumption
timeFrame: up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.
Secondary outcomes:
measure: postoperative pain score assessed by Visual Analogue Scale VAS (1-10)
timeFrame: from the time at the end of surgery to 24 weeks after surgery
measure: postoperative pain score assessed by Numeric Rating Scales, NRS (1-10)
timeFrame: from the time at the end of surgery to 24 weeks after surgery
measure: sensations of touch on the chest wall
timeFrame: from the time at the end of surgery to 24 weeks after surgery
measure: non-opioid analgesic drug use
timeFrame: from the time at the end of surgery to 24 weeks after surgery
measure: length of stay (LOS)
timeFrame: 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
measure: ambulation time
timeFrame: up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure
measure: total cost of hospitalization
timeFrame: up to 1 month, total charges settled on the day of discharge
measure: long-term postoperative analgesia
timeFrame: from the time at the end of surgery to 24 weeks after surgery
measure: adverse events
timeFrame: from the time at the end of surgery to 24 weeks after surgery
measure: chest tube removal time
timeFrame: from the time at the end of surgery to 24 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Zhen Rong ZHANG, Doctor
role: STUDY_DIRECTOR
References: