Minimum bupivacaine volume for the serratus posterior superior intercostal plane block in VATS
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
NA · Bursa City Hospital · NCT07446959
This study will see if smaller volumes of 0.25% bupivacaine can provide effective pain relief with an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for adults having video-assisted thoracoscopic surgery (VATS).
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bursa City Hospital (other gov) |
| Locations | 1 site (Bursa) |
| Trial ID | NCT07446959 on ClinicalTrials.gov |
What this trial studies
This prospective, interventional dose-finding study uses the Dixon up-and-down sequential allocation method to determine the median effective volume (ED50) of 0.25% bupivacaine for an ultrasound-guided SPSIP block in adults undergoing elective VATS. The first patient receives an initial volume and subsequent volumes are adjusted in 2 mL steps: decreased after a successful block or increased after a failure, until nine reversal points are reached. Block success is defined by sensory loss to cold in at least two consecutive T3–T6 dermatomes at 20–30 minutes plus cumulative fentanyl <2 µg/kg in the first 60 minutes after induction; failures include inadequate sensory block or fentanyl ≥2 µg/kg. Secondary outcomes include postoperative pain scores and opioid consumption.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective VATS with ASA physical status I–III who can give informed consent and are planned to receive an ultrasound-guided SPSIP block.
Not a fit: Patients with contraindications to regional anesthesia (including infection at the injection site, coagulopathy, anticoagulation), known allergy to local anesthetics, severe respiratory insufficiency, chronic opioid use, pregnancy, or inability to report pain are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could reduce local anesthetic exposure while maintaining effective thoracic postoperative analgesia and lowering opioid needs and related side effects.
How similar studies have performed: Related serratus-plane and intercostal plane block techniques have shown effective postoperative analgesia after thoracic surgery, but ED50 data for the specific SPSIP approach are limited, so this dose-finding application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Bursa
- T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi — Bursa, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: emre ulusoy
- Email: emreulusoy36@gmail.com
- Phone: +905379492799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Pain Management, Video-assisted Thoracoscopic Surgery, SPSIP Block, Regional Anesthesia, Dose-Finding Study, Dixon Up-and-Down Method, Thoracic Analgesia