Comparison of Analgesic Effect and Postoperative Recovery of SAPB Combined With ESPB and TPB After Thoracoscopic Surgery

Comparison of Analgesic Effect and Postoperative Recovery of Serratus Anterior Plane Block Combined With Erector Spinae Plane Block and Thoracic Paravertebral Block After Thoracoscopic Surgery

After thoracoscopic surgery, patients still face moderate to severe pain. How to effectively control pain and promote postoperative recovery of patients is a challenging problem. Thoracic paraspinal block is effective in controlling pain after thoracoscopic surgery, but it also carries the risk of difficulty in operation and puncture of the pleura. In recent years, erector spinal plane block and serratus anterior plane block have been used for postoperative analgesia after thoracoscopic surgery. The purpose of this study was to explore whether erector spinal plane combined with serratus anterior plane block can replace thoracic paravertebral block and provide a more complete analgesia after thoracoscopic surgery. Therefore, this study is of great clinical significance.

Study Overview

• Status: Recruiting
• Conditions: Thoracoscopic Surgery; Nerve Block
• Intervention / Treatment: Procedure: erector spinal plane combined with serratus anterior plane block

Detailed Description

In a double-blind randomized controlled study, investigators allocated 92 patients undergoing VATS to either SAPB Combined With ESPB or TPB, with both groups receiving otherwise standardized treatment, including multimodal analgesia. The primary outcome was 24-hr opioid consumption. Secondary outcomes included the number of survival analgesia at 1, 2, 4, 8, and 24 hours postoperatively ,VAS scores was assessed during resting and coughing statuses at 1, 2, 4, 8, and 24 hours postoperatively, pulmonary function indexes before and 1, 4, 24 hours after surgery , QOR-15 scores before and 24 hours after surgery, postoperative complications and recovery time nodes drainage tube removal time, discharge time.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Zhang, Dr.; Phone Number: 13986039131; Email: doc_zhang18@163.com
• Study Contact Backup: Name: Xuan Mo; Phone Number: 18776768640; Email: mx1173572700@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
      • Contact: Yi Zhang; Phone Number: 13986039131; Email: doc_zhang18@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. American ASA Grade I-III;
2. Age: 18 ~ 70 years old;

3 BMI 19 ~ 28kg/m2;

4. Patients with elective thoracoscopic partial pneumonectomy under general anesthesia;

5 Informed Consent has been signed.

Exclusion Criteria:

1. Use opioid analgesics on a daily basis or have a history of opioid abuse;
2. History of ipsilateral thoracotomy;
3. Allergic to any of the drugs used in the study, or have a history of drug allergy;
4. Mental or nervous system diseases, motor or sensory deficits;

5 there is coagulation dysfunction;

6. Cognitive dysfunction, unable to cooperate with research;

7. Severe renal, hepatic or cardiac dysfunction;

8. Chest wall and spine trauma, infection, deformity and other cases where nerve block cannot be performed;

9. Participated in other clinical trials within the 3 months prior to study inclusion;

10. Investigators consider other reasons unsuitable for clinical trial participants;

11. Patients refuse to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESPB&SAPB; erector spinal plane block combined with serratus anterior plane block	Procedure: erector spinal plane combined with serratus anterior plane block; The experimental group received ultrasound-guided erector spinal block combined with serratus anterior plane block, and erector spinal block was performed at the T5 and T7 levels with 10ml 0.4% ropivacaine for each level, and 20ml 0.4% ropivacaine for serratus anterior plane block. The control group received ultrasound-guided thoracic paravertebral block at T5 and T7 levels, respectively, with 20ml 0.4% ropivacaine at each level.; Other Names: thoracic paravertebral block
Active Comparator: TPVB; thoracic paravertebral block	Procedure: erector spinal plane combined with serratus anterior plane block; The experimental group received ultrasound-guided erector spinal block combined with serratus anterior plane block, and erector spinal block was performed at the T5 and T7 levels with 10ml 0.4% ropivacaine for each level, and 20ml 0.4% ropivacaine for serratus anterior plane block. The control group received ultrasound-guided thoracic paravertebral block at T5 and T7 levels, respectively, with 20ml 0.4% ropivacaine at each level.; Other Names: thoracic paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dose of opioids used	dosage of analgesic pump	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dose of opioids used	dosage of analgesic pump	1hour, 2hours, 4hours, 8hours and 48hours postoperatively after surgery
The number of survival analgesia	times of rescue analgesia	1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
VAS scores at resting and coughing state	visual analog pain scale	1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
pulmonary function indexes	FVC (L)	Preoperative, postoperative 1hour, postoperative 4hours and postoperative 24hours
QOR-15 scores	The highest score is 150,the lowest score is 0. The higher the score, the better off the patient was.	before and 24 hours after surgery
Postoperative complications and recovery time nodes	drainage tube removal time, length of stay, etc.	follow up patients for an average of half a month

Collaborators and Investigators

• Sponsor: Zhangyi

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 10, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1000012129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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