Minimum Effective Volume of Bupivacaine for Serratus Posterior Superior Intercostal Plane Block in Video-Assisted Thoracoscopic Surgery
SPSIP-EV50
Determination of the Median Effective Volume (ED50) of Bupivacaine for Serratus Posterior Superior Intercostal Plane Block in Patients Undergoing Video-Assisted Thoracoscopic Surgery Using the Dixon Up-and-Down Method
1 other identifier
interventional
27
1 country
1
Brief Summary
This study aims to determine the minimum effective volume of bupivacaine required for the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing video-assisted thoracoscopic surgery (VATS). The SPSIP block is an ultrasound-guided regional anesthesia technique used to provide postoperative pain relief after thoracic surgery. Using a stepwise dose-adjustment method, the volume of local anesthetic will be increased or decreased based on the effectiveness of the block in each patient. The main outcome of the study is to identify the volume that provides effective pain control in 50% of patients. The results may help optimize pain management while minimizing drug exposure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2026
ExpectedMay 12, 2026
May 1, 2026
2 months
February 26, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Effective Volume (ED50) of 0.5% Bupivacaine for Successful SPSIP Block
The median effective volume (ED50) of 0.5% bupivacaine required to achieve successful postoperative analgesia following ultrasound-guided serratus posterior superior intercostal plane block, determined using the Dixon up-and-down sequential allocation method.
Within the first 30 minutes after block performance
Secondary Outcomes (5)
Postoperative Pain Scores (NRS)
Up to 24 hours postoperatively
Postoperative Morphine Consumption via Patient-Controlled Analgesia (PCA)
First 24 hours after surgery
Postoperative Adverse Effects
Up to 24 hours postoperatively
Quality of Recovery Score (QoR-15)
24 hours after surgery
Postoperative Pulmonary Function Parameters
Preoperative baseline and 24 hours after surgery
Study Arms (1)
Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
EXPERIMENTALParticipants receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) with 0.5% bupivacaine before video-assisted thoracoscopic surgery (VATS). The injected volume is determined using the Dixon up-and-down sequential allocation method, starting from an initial volume and adjusted by 2 mL increments or decrements based on block success or failure in the preceding patient. Block success is assessed by a blinded outcome assessor according to predefined analgesic criteria.
Interventions
Ultrasound-guided serratus posterior superior intercostal plane block performed prior to general anesthesia in patients undergoing video-assisted thoracoscopic surgery (VATS). A 0.5% bupivacaine solution is injected, and the volume is adjusted in 2 mL increments according to the Dixon up-and-down sequential allocation method to determine the median effective volume (ED50).
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Scheduled for elective video-assisted thoracoscopic surgery (VATS)
- American Society of Anesthesiologists (ASA) physical status I-III
- Planned to receive ultrasound-guided serratus posterior superior intercostal plane block for postoperative analgesia
- Ability to provide written informed consent
You may not qualify if:
- Refusal to participate in the study
- Known allergy or contraindication to local anesthetics
- Infection at the block injection site
- Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
- Severe respiratory insufficiency
- Chronic opioid use or chronic pain syndrome
- Pregnancy
- Inability to cooperate or communicate postoperative pain scores
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bursa City Hospitallead
- Ulusoy, Emre, M.D.collaborator
Study Sites (1)
T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi
Bursa, 16250, Turkey (Türkiye)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof.
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 3, 2026
Study Start
March 15, 2026
Primary Completion
May 11, 2026
Study Completion (Estimated)
July 15, 2026
Last Updated
May 12, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.