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

NCT ID: NCT05538429

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-11-01

Brief Summary

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.

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.

Conditions

Thoracoscopic Surgery; Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

ESPB&SAPB

erector spinal plane block combined with serratus anterior plane block

Group Type: EXPERIMENTAL

erector spinal plane combined with serratus anterior plane block

Intervention Type: PROCEDURE

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.

TPVB

thoracic paravertebral block

Group Type: ACTIVE_COMPARATOR

erector spinal plane combined with serratus anterior plane block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

thoracic paravertebral block

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhangyi

OTHER

Sponsor Role: lead

Responsible Party

Zhangyi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Zhang, Dr.

Role: CONTACT

doc_zhang18@163.com

13986039131

Xuan Mo

Role: CONTACT

mx1173572700@163.com

18776768640

Facility Contacts

Yi Zhang

Role: primary

doc_zhang18@163.com

13986039131

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1000012129

Identifier Type: -

Identifier Source: org_study_id