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

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06016777

Collaborator

(none)

102

Enrollment

Arms

24.7

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Uniportal Video-assisted Thoracic Surgery	Procedure: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump Procedure: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump Procedure: Patient-controlled intravenous analgesia pump	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Patients will be grouped by block randomization method (1:1:1) by a researcher who is unaware of the meaning of the group code. Patients will be stratified by ID numbers with a block of 6. Within each block, random sequences between 0 and 1 are generated. The group code (A, B or C) will be defined as the remainder of the serial number divided by three. The group code will be put in a light-proof envelope. Patients with the envelope will be transferred to the OR, unaware of the group assignment throughout the study. After induction, the anesthesiologist opens the light-proof envelope and get the group code. Group codes will be recorded in the CRF table with the cards destroyed. Only the principal investigator and the anesthesiologists know the intervention represented by the group code. The anesthesiologists will not involve in postoperative follow-ups or data collection. Neither doctors in charge of postoperative follow-ups nor the statisticians will know the specific interventions.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 10, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PVB+PCIA group	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: 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.
Experimental: ESB+PCIA group	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.
Active Comparator: PCIA group	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.

Arm

Intervention/Treatment

Experimental: PVB+PCIA group

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: 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.

Experimental: ESB+PCIA group

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

Active Comparator: PCIA group

Procedure: Patient-controlled intravenous analgesia pump

Outcome Measures

Primary Outcome Measures

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

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
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
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
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
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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