Clinical trial NCT06441071: Patients' Positions on Analgesic Efficacy of ESPB
Official title: Effect of Different Patient's Positions on Postoperative Analgesia of Ultrasound-guided Erector Spinae Plane Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erector Spinae Plane Block
Keywords: Paravertebral thoracic block
Clinical application
Perioperative analgesia
Erector spinae plane block
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 fifth 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.

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.

Primary outcomes:
measure: Postoperative Oxycodone dosage
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: Loss to cold sensation of skin
timeFrame: 30 minute after block
measure: NRS(Numeric Rating Scales) score
timeFrame: Postoperative 1, 3, 6, 12, 24, 48 hour
measure: Adverse reaction
timeFrame: 24, 48 hour postoperatively
measure: QoR-15 score(Quality of Recovery,QoR)
timeFrame: Day 1 and 2 postoperatively
measure: Opioid dosage
timeFrame: 1, 3, 6, 12, 24, 48 hour postoperatively
measure: Patient Comfort Scale score
timeFrame: 30 minute after block
measure: Hemodynamic profile
timeFrame: Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
measure: Hemodynamic profile
timeFrame: Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Tao Shan
role: STUDY_DIRECTOR
References: