NCT05538429

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

January 27, 2022

Last Update Submit

September 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The dose of opioids used

    dosage of analgesic pump

    24 hours after surgery

Secondary Outcomes (6)

  • The dose of opioids used

    1hour, 2hours, 4hours, 8hours and 48hours postoperatively after surgery

  • The number of survival analgesia

    1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery

  • VAS scores at resting and coughing state

    1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery

  • pulmonary function indexes

    Preoperative, postoperative 1hour, postoperative 4hours and postoperative 24hours

  • QOR-15 scores

    before and 24 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

ESPB&SAPB

EXPERIMENTAL

erector spinal plane block combined with serratus anterior plane block

Procedure: erector spinal plane combined with serratus anterior plane block

TPVB

ACTIVE COMPARATOR

thoracic paravertebral block

Procedure: erector spinal plane combined with serratus anterior plane block

Interventions

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.

Also known as: thoracic paravertebral block
ESPB&SAPBTPVB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American ASA Grade I-III;
  • Age: 18 \~ 70 years old;
  • BMI 19 \~ 28kg/m2;
  • \. Patients with elective thoracoscopic partial pneumonectomy under general anesthesia;
  • Informed Consent has been signed.

You may not qualify if:

  • Use opioid analgesics on a daily basis or have a history of opioid abuse;
  • History of ipsilateral thoracotomy;
  • Allergic to any of the drugs used in the study, or have a history of drug allergy;
  • Mental or nervous system diseases, motor or sensory deficits;
  • there is coagulation dysfunction;
  • \. Cognitive dysfunction, unable to cooperate with research;
  • \. Severe renal, hepatic or cardiac dysfunction;
  • \. Chest wall and spine trauma, infection, deformity and other cases where nerve block cannot be performed;
  • \. Investigators consider other reasons unsuitable for clinical trial participants;
  • \. Patients refuse to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2022

First Posted

September 13, 2022

Study Start

June 1, 2021

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations