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Active, not recruiting Not applicable

Comparison of Serratus Posterior Superior Intercostal Plane Block and Paravertebral Block for Post-Thoracotomy Pain Management

NCT07768826 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-08-17

Condition(s) studied

Postthoracotomy Pain

Investigational drug(s) / intervention(s)

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Paravertebral Block (PVB)

Serratus Posterior Superior Intercostal Plane Block (SPSIPB): In this study, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) will be performed under ultrasound guidance using an in-plane technique at the level of the superomedial border of the scapula. The block will be administered by injecting local anesthetic into the interfascial plane between the serratus posterior superior muscle and the second or third intercostal muscle. Bupivacaine at a concentration of 0.25% will be used as the local anesthetic agent. The total dose administered will be calculated according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. In routine clinical practice, an injection volume of 25-30 mL of bupivacaine is generally sufficient to achieve an effective block in most patients.

Paravertebral Block (PVB): Thoracic Paravertebral Block (PVB) will be performed under ultrasound guidance using an in-plane technique at the T4-T6 thoracic vertebral levels. The needle tip will be advanced into the paravertebral space located between the transverse process and the parietal pleura. For PVB, 0.25% bupivacaine will be used as the local anesthetic agent. The total dose will be adjusted according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. Based on evidence from the literature, an injection volume of 25-30 mL of bupivacaine generally provides adequate spread in the majority of patients. All block procedures will be performed by an experienced anesthesiologist and a resident physician involved in the study. Following block administration, all patients will undergo general anesthesia, and thoracic surgical procedures will subsequently be performed via thoracotomy by the thoracic surgery team.

Study summary

Patients undergoing thoracic surgery via thoracotomy are required to remain in the lateral decubitus position for prolonged periods due to surgical access requirements. This positioning is considered one of the major contributors to postoperative shoulder pain, particularly because of the mechanical stress imposed on the dependent shoulder and scapulothoracic region. The resulting pain not only reduces patient comfort but may also delay early mobilization, thereby adversely affecting respiratory function and the recovery of postoperative pulmonary capacity . Therefore, in thoracic surgery, the ability of regional anesthesia techniques to provide sensory coverage extending beyond the incision site to include dermatomes associated with the shoulder girdle has emerged as a critical factor influencing analgesic efficacy.

In this context, the present study aims to comprehensively compare Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Thoracic Paravertebral Block (PVB) with respect to both the management of post-thoracotomy postoperative shoulder pain and their overall analgesic effectiveness. Furthermore, the contribution of these two techniques to postoperative pain management will be thoroughly evaluated in terms of patient comfort and safety profiles.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria * Patients scheduled to undergo elective thoracic surgery via thoracotomy * Patients aged between 18 and 75 years * Patients classified as American Society of Anesthesiologists (ASA) physical status I-III * Patients who provide written informed consent to participate in the study Exclusion Criteria * Patients with a known allergy or hypersensitivity to local anesthetic agents * Patients with coagulation disorders or those receiving anticoagulant therapy * Pregnant or breastfeeding women * Patients with impaired consciousness or inability to communicate effectively * Patients in whom block administration is unsuccessful * Patients who decline regional block administration * Patients with mental or cognitive impairment precluding reliable preoperative pain assessment * Patients with intolerance to or contraindications for morphine or other opioid medications * Patients who voluntarily choose to withdraw from the study at any stage of the research process * Patients who develop intraoperative surgical complications * Patients who experience hemodynamic complications during the perioperative period * Patients who develop serious postoperative medical complications requiring intensive care unit admission, reoperation, or other major medical interventions * Patients with incomplete follow-up data or in whom opioid consumption cannot be accurately assessed due to technical malfunction of the patient-controlled analgesia (PCA) device will be excluded from the final analysis.

Primary outcome measure(s)

  • Assessment of Postoperative Pain Intensity — Postoperative pain evaluations will be performed and recorded at predefined intervals during the first 24 postoperative hours, namely at 0, 1, 6, 12, and 24 hours after surgery.
    Pain severity will be evaluated using the Numeric Rating Scale (NRS; 0-10), with 0 indicating no pain and 10 indicating the worst imaginable pain.
  • Assessment of Postoperative Shoulder Pain — Postoperative shoulder pain evaluations will be recorded at predetermined intervals during the first 24 hours postoperatively, namely at 0, 1, 6, 12, and 24 hours.Furthermore, shoulder pain assessments will be repeated at the one-month postoperative foll
    Postoperative shoulder pain will be evaluated based on its presence or absence and quantified using the Numeric Rating Scale (NRS).The occurrence, duration, and severity of shoulder pain will be documented throughout the study period.

Trial sites (1)

FacilityCityRegionStatus
Ankara bilkent şehir hastanesi Ankara Çankaya
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07768826 on ClinicalTrials.gov ↗ ← All trials in Turkey