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

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

Study Overview

• Status: Recruiting
• Conditions: Uniportal Video-assisted Thoracic Surgery
• Intervention / Treatment: Procedure: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump; Procedure: Patient-controlled intravenous analgesia pump; Procedure: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump

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 Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Fang WANG, Doctor; Phone Number: +8615011393879; Email: lilythewolf@sina.com
• Study Contact Backup: Name: Zhen Rong ZHANG, Doctor; Phone Number: +8613811000378; Email: doctor_zzr@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Li Fang Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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.; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total opioid consumption	total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.	up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain score assessed by Visual Analogue Scale VAS (1-10)	rest and cough pain	from the time at the end of surgery to 24 weeks after surgery
postoperative pain score assessed by Numeric Rating Scales, NRS (1-10)	rest and cough pain	from the time at the end of surgery to 24 weeks after surgery
sensations of touch on the chest wall	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	from the time at the end of surgery to 24 weeks after surgery
non-opioid analgesic drug use	number of patients with long-term (≥3 days) use of non-opioid analgesic drug	from the time at the end of surgery to 24 weeks after surgery
length of stay (LOS)	days of hospital stay	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
ambulation time	first time of successful activity off bed, the time between the end of surgery to the time of the first successful ambulation	up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure
total cost of hospitalization	the in-patients costs total cost of hospitalization=medication cost + hospitalization cost + nursing cost + delay compensation	up to 1 month, total charges settled on the day of discharge
long-term postoperative analgesia	number of patient who needs long-term postoperative analgesia (≥3 days after discharge)	from the time at the end of surgery to 24 weeks after surgery
adverse events	Adverse reactions such as dizziness, nausea, vomiting, drowsiness, dyspnea, fatigue, constipation and urinary retention were recorded in detail	from the time at the end of surgery to 24 weeks after surgery
chest tube removal time	The time from surgery to removal of the chest drainage tube	from the time at the end of surgery to 24 weeks after surgery

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Study Director: Zhen Rong ZHANG, Doctor, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; Enhanced Recovery After Surgery; paravertebral block; fast-track; uniportal video-assisted thoracoscopic surgery; thoracoscopic; ultrasonic guidance; erector spinal block
• Other Study ID Numbers: ChinaJapanFHAnesth2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Security cameras are set up next to both the computer and the cabinet for data storage. The surveillance video will be available only to medical staff and the principal investigator. Access to data will be restricted to authorized personnel, including ethics committee directors, principal investigator and authorized personnel. Access to paper documents as well as electronic data must be registered, with the name of operator and detailed reasons recorded.

The results and conclusions of our research will be reported to all the participants, research team, and the public in peer-reviewed journal. The investigators will try to put forward the existing guidelines to further optimization of perioperative anesthesia and analgesia protocol for small-incision thoracic surgery and optimized drainage tube strategy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No