Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06142630
Collaborator
(none)
30
1
3
26.4
1.1

Study Details

Study Description

Brief Summary

After the completion of exploring the vertical erector spinae plane block, the patient maintains different positions to assess the diffusion of local anesthetic and the effect of the block.

Condition or Disease Intervention/Treatment Phase
  • Other: Alteration of patients' position after erector spinae plane block
N/A

Detailed Description

Thirty patients were selected to undergo CT guided puncture localization of pulmonary nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Randomly divide patients into three groups: supine position group (S group, 10 cases), prone position group (P group, 10 cases), and lateral position group (L group, 10 cases). The patient underwent ultrasound guided ESPB on the puncture side before CT puncture localization. Ultrasound guided ESPB method: Using an ultrasound high-frequency linear array probe (5-13MHz, Sonosite, USA), the probe is placed parallel to the spine on the surface of the transverse process tip of the fifth thoracic vertebrae. Under ultrasound, the transverse process and surface vertical spinal muscles are clearly exposed. Then, a short inclined plane puncture needle is used, and the needle is inserted from the head side using in-plane technology. After the needle tip reaches below the transverse process plane vertical spinal muscles, 2ml of physiological saline is injected using water separation technology to confirm the position of the needle tip, Then inject 30ml of local anesthetic solution (0.375% ropivacaine 25ml+iohexol 5ml). After the block was completed, patients in Group S remained in a supine position; Patients in group L maintained the blocking side above; Patients in Group P maintained a prone position. After 1 hour of block completion, CT scan and puncture localization were performed, followed by 3D reconstruction. Observation and recording of local anesthetic solution: 1. Diffusion range towards the head and tail; 2-way diffusion range of rib gap on one side 3; Diffusion to the paravertebral space; 4. Diffusion into the epidural space.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effects of Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block
Actual Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Supine group

Patients remained supine

Experimental: Prone group

Patient remained prone

Other: Alteration of patients' position after erector spinae plane block
After the erector spinae plane block was completed, the patients kept lateral or prone position according to the group allocated for one hour to ensure the spread of local anesthetic

Experimental: Lateral position group

Patient remained in a lateral position

Other: Alteration of patients' position after erector spinae plane block
After the erector spinae plane block was completed, the patients kept lateral or prone position according to the group allocated for one hour to ensure the spread of local anesthetic

Outcome Measures

Primary Outcome Measures

  1. Incidence and number of local anesthetic diffusion segment into the paravertebral space [1 hour after completion of the ESPB block]

    Observation of local anesthetic spread spread into the paravertebral space with CT by a researcher who was blinded to group allocation

Secondary Outcome Measures

  1. Diffusion of local anesthetic into intercostal space [1 hour after completion of the block]

    The diffusion of local anesthetics to intercostal space was observed with CT by a researcher who was blinded to group allocation

  2. Diffusion of local anesthetic into the epidural space [1 hour after completion of the block]

    Incidence and segment of local anesthetic spread into the epidural was assessed by a researcher who was blinded to group allocation

  3. Sensory loss of cold [30 min and 60 min immediately after completion of the nerve block]

    The extent of sensory loss was assessed with cold stimulation, including the anterior chest wall (midclavicular line), lateral chest wall (posterior axillary line), and posterior chest wall (paraspinal zone) by a researcher who was blinded to group allocation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Patients received CT guided puncture localization of pulmonary nodules under local anesthesia

Exclusion Criteria:
  1. Allergic to local anesthetic

  2. History of opioid abuse

  3. Severe skin infection

  4. Peripheral neuropathy

  5. Dysfunction of blood coagulation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanjing First Hospital Nanjing Nanjing China 210006

Sponsors and Collaborators

  • Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Gu Jianping, Nanjing First Hospital, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT06142630
Other Study ID Numbers:
  • KY20230915-04
First Posted:
Nov 21, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 21, 2023