Patients' Positions on Analgesic Efficacy of ESPB

NCT ID: NCT06441071

Last Updated: 2025-07-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-14
• Study Completion Date: 2026-12-01

Brief Summary

The goal of this clinical trial is to learn if patients remaining different positions for 30min after receiving ultrasound-guided erector spinae plane block influenced the postoperative analgesia. The main questions it aims to answer are:

Does patients maintain prone position or lateral position for 30 min after ESPB provided superior analgesic effect than in the supine position? Is ESPB not inferior to PVB considering postoperative opioid consumption ? Researchers will compare the opioid consumption 24h postoperatively among the patients remaining supine, lateral, prone position after ESPB and PVB to see if patients maintaining lateral or prone position provided excellent postoperative analgesia.

Participants will:

Maintaining supine lateral or prone position for 30 min following ESPB or receiving PVB.

Receiving postoperative NRS and QoR assessment

Detailed Description

After signed the informed consent form, 200 patients scheduled for elective thoracoscopic surgery were randomly divided into four groups: supine position group (group S, n = 50), prone position group (group P, n = 50), lateral position group (group L, n = 50) and paravertebral block group (group C, n = 50). After ESPB block, the corresponding position was maintained for 30 minutes.

Ultrasound-guided ESPB was performed 30min before general anesthesia. Ultrasound-guided ESPB methods: The ultrasonic high-frequency linear array probe (5-13 MHZ, Sonosite, USA) was placed parallel to the spine on the surface of the transverse process tip of the seventh thoracic vertebra. Under ultrasound, the transverse process and the surface of the erector spinae were clearly exposed. Then a long beved-plane needle was used, and the needle was inserted from the head side. 2ml of normal saline was injected using the water separation technique to confirm the position of the needle tip, and then 30ml 0.375% ropivacaine was injected.

After completion of the block, patients in group S were kept in the supine position for 30min, patients in group L were kept in the upper lateral position for 30min, and patients in group P were kept in the prone position for 30min. After 30 minutes of observation, an anesthesiologist who was unaware of the grouping used an ice cube to determine the extent of sensory block. General anesthesia was then performed.

General anesthesia was performed as follows: routine ECG monitoring was performed after the patient was admitted to the operating room, and invasive arterial blood pressure was monitored by radial artery puncture and catheterization. General anesthesia was induced with dexamethasone 10mg, midazolam 0.05mg.kg-1, propofol 1.5-2.0 mg.kg-1, sufentanil 0.2 ug.kg-1, cisatracurium 0.2 mg.kg-1, and then a double-luminal bronchial tube was inserted under a video laryngoscope and mechanically ventilated (tidal volume: 6-10ml.kg-1,PEEP: 3-5 cm H2O). Anesthesia was maintained with propofol (2-4 mg.kg-1.h-1), remifentanil (0.12-0.3 ug.kg-1.min-1) and Micuronium (0.6mg.kg-1.h-1). Intraoperative hemodynamics was maintained within 20% of baseline. Flurbiprofen axetil 50mg was given intravenously for analgesia and tropisetron 4mg was given to prevent nausea and vomiting when there were no contraindications during the operation. Oxycodone 3mg was administered intravenously 30min before the end of the procedure. At the end of the operation, the patient was transferred to PACU with an endotracheal tube. After neuromuscular blocking antagonism, the tracheal tube was extubated.

NRS was used to evaluate the pain scores at rest and during movement at 1, 3, 6, 12 and 24h ，48h after operation by a nurse who was unaware of the grouping. Oxycodone 30mg diluted to 150ml was used for patient-controlled intravenous analgesia after operation. The parameters of analgesia pump were set as background dose 0.5 ml.h-1, bolus 5ml, lockout time 8min. If NRS≥4 at rest after surgery, patient-controlled analgesia (PCA) was performed by pressing the PCA pump. When NRS≥4 at rest was still ≥4 after two times of PCA, oxycodone 1mg was given once as rescue analgesia, and the patients were reevaluated until NRS≤3.

Conditions

Erector Spinae Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group S

After completion of the erector spinae plane block, patients in group S remained in the supine position for 30 minutes.

Group Type: EXPERIMENTAL

position

Intervention Type: PROCEDURE

Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured.

Group L

After completion of the erector spinae plane block, patients in group L remained in the lateral position for 30 minutes.

Group Type: EXPERIMENTAL

position

Intervention Type: PROCEDURE

Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured.

Group P

After completion of the erector spinae plane block, patients in group P remained in the prone position for 30 minutes.

Group Type: EXPERIMENTAL

position

Intervention Type: PROCEDURE

Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured.

Group C

After completion of the paravertebral block, patients in group C remained in the supine position for 30 minutes.

Group Type: OTHER

position

Intervention Type: PROCEDURE

Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured.

Interventions

position

Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients undergoing Video-assisted Thoracoscopic Surgery under elective general anaesthesia were selected, regardless of sex, age 18-80 years, BMI: 18-30 kg.m-2, ASA classification I-III.

Exclusion Criteria

1. Allergy to the study drug or allergy to local anaesthetics;

2. History of opioid abuse;

3. Previous nerve block puncture with puncture site infection；

4. Peripheral neuropathy；

5. Coagulation abnormalities, defined as prothrombin time or partial activation time prothrombin time exceeding standard values or international normalised ratio (INR) ≥ 1.4, or platelet count ≤ 70 x 109 L-1.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Shan

Role: STUDY_DIRECTOR

Nanjing First Hospital, Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinyi Bu, MD

Role: CONTACT

1037031075@qq.com

+86 18360868010

Facility Contacts

Xinyi Bu, MD

Role: primary

1037031075@qq.com

+8618360868010

Other Identifiers

KY20240419-03

Identifier Type: -

Identifier Source: org_study_id