NCT07020624

Brief Summary

Thoracotomy is known as one of the most painful surgical procedures, with up to 65% of patients developing chronic post-thoracotomy pain syndrome (PTPS), and approximately 10% experiencing pain that significantly impacts quality of life. Video-assisted thoracoscopic surgery (VATS) has become increasingly common over the past decade and offers reduced postoperative pain, morbidity, and length of hospital stay compared to open thoracotomy. However, VATS can still cause moderate to severe postoperative pain and a high risk of chronic pain. Optimizing analgesia after VATS remains critical. With advances in ultrasound technology, several regional anesthesia techniques such as serratus anterior plane block (SAPB), erector spinae plane block (ESPB), and thoracic epidural analgesia (TEA) have shown comparable efficacy. In 2023, Tulgar et al. described the serratus posterior superior intercostal plane block (SPSIPB), which demonstrated dermatomal coverage from C3 to T10. This randomized controlled trial aims to compare the analgesic efficacy of SPSIPB and SAPB in patients undergoing VATS procedures.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress79%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

May 22, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

May 22, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

serratus posterior superior intercostal plane blockVideo-assisted thoracoscopic surgeryserratus anterior plane block

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption in the first 24 hours postoperatively

    Morfin consumption in the first 24 hours after surgery

    up to 24 hours

Secondary Outcomes (4)

  • Pain density

    up to 24 hours.

  • Quality of recovery

    24 hours after surgery

  • Nausea and vomiting

    up to 24 hours

  • shoulder pain

    up to 24 hours

Study Arms (2)

group serratus anterior plane block (SAP)

ACTIVE COMPARATOR

At the end of the surgery, ultrasound-guided serratus anterior plane block is performed with 0.25% bupivacaine. Perioperative and postoperative routine analgesic protocol is applied (consisting of intravenous analgesics and intravenous patient-controlled analgesia) without additional intervention (block) Standard Pain Monitoring and Follow-up is performed

Other: SAPB

group serratus posterior superior intercostal plane block(SPSIP)

ACTIVE COMPARATOR

At the end of the surgery, ultrasound-guided serratus posterior superior intercostal plane block is performed with 0.25% bupivacaine. Perioperative and postoperative routine analgesic protocol is applied (consisting of intravenous analgesics and intravenous patient-controlled analgesia) without additional intervention (block) Standard Pain Monitoring and Follow-up is performed

Other: SPSIPB

Interventions

SAPBOTHER

Ultrasound guided serratus anterior plane block will be performed.

group serratus anterior plane block (SAP)
SPSIPBOTHER

Ultrasound guided serratus posterior superior intercostal plane block will be performed.

group serratus posterior superior intercostal plane block(SPSIP)

Eligibility Criteria

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

You may qualify if:

  • BMI \< 35 kg/m² Patients with ASA scores I, II, III

You may not qualify if:

  • Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA \> 3 BMI \> 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site Patients whose surgical procedure time exceeds 150 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University,

Samsun, Ilkadım, 55100, Turkey (Türkiye)

Location

Study Officials

  • hamiyet şenol çakmak, specialist

    samsun university Samsun Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

gamze ertaş, specialist

CONTACT

hamiyet şenol çakmak, specialist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The anesthetist who will perform the blocks will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two interventional group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 13, 2025

Study Start

July 1, 2025

Primary Completion

January 15, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations