Erector Spinae Plane BlockNCT06441071
Patients' Positions on Analgesic Efficacy of ESPB
A study testing position in people with Erector Spinae Plane Block, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Erector Spinae Plane Block
- What is being tested?
- position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2024to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Allergy to the study drug or allergy to local anaesthetics;
- History of opioid abuse;
- Previous nerve block puncture with puncture site infection;
- Peripheral neuropathy;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Patient's Positions on Postoperative Analgesia of Ultrasound-guided Erector Spinae Plane Block
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.
Read more
Participants will:
Maintaining supine lateral or prone position for 30 min following ESPB or receiving PVB.
Receiving postoperative NRS and QoR assessment
Read the 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
- Being tested
- position
- Keywords
- Paravertebral thoracic block, Clinical application, Perioperative analgesia, Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | After completion of the erector spinae plane block, patients in group S remained in the supine position for 30 minutes. Receives: Procedure: position |
| Group L | Experimental | After completion of the erector spinae plane block, patients in group L remained in the lateral position for 30 minutes. Receives: Procedure: position |
| Group P | Experimental | After completion of the erector spinae plane block, patients in group P remained in the prone position for 30 minutes. Receives: Procedure: position |
| Group C | Other | After completion of the paravertebral block, patients in group C remained in the supine position for 30 minutes. Receives: Procedure: position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Oxycodone dosage
Cumulative oxycodone dosage 24 hour postoperatively
Measured: 24 hour postoperatively
Secondary outcomes (8)
Loss to cold sensation of skin
The sensation to cold was assessed with ice. The area include 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.
Measured: 30 minute after block
NRS(Numeric Rating Scales) score
Postoperative 1, 3, 6, 12, 24, 48 hour NRS (Numeric Rating Scales) score. Numerical Rating Scale (NRS): This scale is composed of 11 numbers from 0 to 10, with higher numbers increasing the severity of pain.
Measured: Postoperative 1, 3, 6, 12, 24, 48 hour
Adverse reaction
This includes dizziness, nausea, vomiting, etc.
Measured: 24, 48 hour postoperatively
QoR-15 score(Quality of Recovery,QoR)
Postoperative QoR-15(Quality of Recovery) score was used to evaluate the quality of early postoperative recovery on postoperative day 1 and 2. . The QoR-15 score(Quality of Recovery,QoR) included 5 dimensions including emotional state, physical comfort, psychological support, physical independence and pain, with a total of 15 items. Each item scored from 0 to 10, with higher scores being better.
Measured: Day 1 and 2 postoperatively
Opioid dosage
Postoperative opioid consumption dosage.
Measured: 1, 3, 6, 12, 24, 48 hour postoperatively
Patient Comfort Scale score
used to assess the comfort level of the patient according to the position during the procedure (grade 0=help, 2=uncomfortable, 4=mild discomfort, 6=feeling OK, 8=pretty comfortable, and 10=feeling great)
Measured: 30 minute after block
Hemodynamic profile
Hemodynamic changes(Heart rate ) during blockade procedure
Measured: Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Hemodynamic profile
Hemodynamic changes(Mean arterial pressure ) during blockade procedure
Measured: Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start14 Jun 2024
- Primary completion15 Mar 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Shan, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441071
- Sponsor's protocol ID
- KY20240419-03
- Status last verified
- Aug 2026
- First submitted
- 8 May 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji Y, Zhang H, Jia R, Cheng D, Hu J, Zhou X, Shen Y. Effect of ultrasound-guided erector spinae plane block for preoperative CT-guided percutaneous localization of pulmonary nodules: a randomized controlled trial. J Cardiothorac Surg. 2026 Apr 24;21(1):369. doi: 10.1186/s13019-026-04235-1.
PubMed 42032730
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Patient's Positions on Postoperative Analgesia of Ultrasound-guided Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT06441071
- Acronym / sponsor ID
- KY20240419-03
- Conditions
- Erector Spinae Plane Block
- Keywords
- Paravertebral thoracic block, Clinical application, Perioperative analgesia, Erector spinae plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Procedure: positionAfter completion of the erector spinae plane block, patients in group S remained in the supine position for 30 minutes. |
| Group L | Experimental | Procedure: positionAfter completion of the erector spinae plane block, patients in group L remained in the lateral position for 30 minutes. |
| Group P | Experimental | Procedure: positionAfter completion of the erector spinae plane block, patients in group P remained in the prone position for 30 minutes. |
| Group C | Other | Procedure: positionAfter completion of the paravertebral block, patients in group C remained in the supine position for 30 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Allergy to the study drug or allergy to local anaesthetics;
- History of opioid abuse;
- Previous nerve block puncture with puncture site infection;
- Peripheral neuropathy;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positionPatients 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. | Procedure or surgery | Group C, Group L, Group P, Group S |
Primary outcome
Postoperative Oxycodone dosage
Time frame: 24 hour postoperatively
Cumulative oxycodone dosage 24 hour postoperatively
8 secondary outcomes
Loss to cold sensation of skin
Time frame: 30 minute after block
NRS(Numeric Rating Scales) score
Time frame: Postoperative 1, 3, 6, 12, 24, 48 hour
Adverse reaction
Time frame: 24, 48 hour postoperatively
QoR-15 score(Quality of Recovery,QoR)
Time frame: Day 1 and 2 postoperatively
Opioid dosage
Time frame: 1, 3, 6, 12, 24, 48 hour postoperatively
Patient Comfort Scale score
Time frame: 30 minute after block
Hemodynamic profile
Time frame: Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Hemodynamic profile
Time frame: Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 42032730Ji Y, Zhang H, Jia R, Cheng D, Hu J, Zhou X, Shen Y. Effect of ultrasound-guided erector spinae plane block for preoperative CT-guided percutaneous localization of pulmonary nodules: a randomized controlled trial. J Cardiothorac Surg. 2026 Apr 24;21(1):369. doi: 10.1186/s13019-026-04235-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Shan study director
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing position in people with Erector Spinae Plane Block, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Oxycodone dosage (time frame: 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.