Clinical trial NCT06142630: Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block
Official title: The Effects of Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinea Plane Block
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Eighty-four 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, 28 patients), prone position group (P group, 28 patients), and lateral position group (L group, 28 patients). The patients 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 seventh thoracic vertebrae. Under ultrasound, the transverse process and 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 between the transverse process and erector spinae muscles, 1ml of physiological saline is injected using water separation technology to confirm the position of the needle tip, Then inject 30ml of local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). 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 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was LA-contrast spread to the paravertebral space.The second outcomes were as follow: 1. spread to the neural foramina 2. cranio-caudal spread 3. spread to the epidural space 4. spread to the intercostal space.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence and number of local anesthetic diffusion segment into the paravertebral space
timeFrame: 30 minute after completion of the ESPB block
Secondary outcomes:
measure: Diffusion of local anesthetic into intercostal space
timeFrame: 30 minute after completion of the block
measure: Diffusion of local anesthetic into the epidural space
timeFrame: 30 minute after completion of the block
measure: Sensory loss of cold
timeFrame: 30 minute immediately after completion of the nerve block
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Nanjing
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Gu Jianping
role: STUDY_CHAIR
References:
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.
citation: Ueshima H, Otake H. RETRACTED: Erector spinae plane block provides effective pain management during pneumothorax surgery. J Clin Anesth. 2017 Aug;40:74. doi: 10.1016/j.jclinane.2017.04.016. Epub 2017 Apr 28. No abstract available.