NCT07446959

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

77
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 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 Progress57%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

February 26, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

SPSIP BlockRegional AnesthesiaDose-Finding StudyDixon Up-and-Down MethodThoracic Analgesia

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)

EXPERIMENTAL

Participants 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.

Other: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

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).

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

Eligibility Criteria

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

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

Study Sites (1)

T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi

Bursa, 16250, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Sequential dose-adjustment design using the Dixon up-and-down method, in which local anesthetic volume is increased or decreased in fixed 2 mL steps based on the success or failure of the preceding block.
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.

Locations