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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538429
• Other study ID #: 1000012129
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2022
• Source: Tongji Hospital
• Contact: Yi Zhang, Dr.
• Phone: 13986039131
• Email: doc_zhang18[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Block
• Thoracoscopic Surgery

Intervention

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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhangyi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dose of opioids used	dosage of analgesic pump	24 hours after surgery
Secondary	The dose of opioids used	dosage of analgesic pump	1hour, 2hours, 4hours, 8hours and 48hours postoperatively after surgery
Secondary	The number of survival analgesia	times of rescue analgesia	1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
Secondary	VAS scores at resting and coughing state	visual analog pain scale	1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
Secondary	pulmonary function indexes	FVC (L)	Preoperative, postoperative 1hour, postoperative 4hours and postoperative 24hours
Secondary	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
Secondary	Postoperative complications and recovery time nodes	drainage tube removal time, length of stay, etc.	follow up patients for an average of half a month