NCT06441071

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

May 8, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

June 14, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

May 8, 2024

Last Update Submit

July 17, 2025

Conditions

Keywords

Paravertebral thoracic blockClinical applicationPerioperative analgesiaErector spinae plane block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Oxycodone dosage

    Cumulative oxycodone dosage 24 hour postoperatively

    24 hour postoperatively

Secondary Outcomes (8)

  • Loss to cold sensation of skin

    30 minute after block

  • NRS(Numeric Rating Scales) score

    Postoperative 1, 3, 6, 12, 24, 48 hour

  • Adverse reaction

    24, 48 hour postoperatively

  • QoR-15 score(Quality of Recovery,QoR)

    Day 1 and 2 postoperatively

  • Opioid dosage

    1, 3, 6, 12, 24, 48 hour postoperatively

  • +3 more secondary outcomes

Study Arms (4)

Group S

EXPERIMENTAL

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

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.

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.

Procedure: position

Group C

OTHER

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

Procedure: position

Interventions

positionPROCEDURE

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 CGroup LGroup PGroup S

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tao Shan

    Nanjing First Hospital, Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2024

First Posted

June 4, 2024

Study Start

June 14, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations