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SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery

ConditionsChronic Post-thoracotomy PainNeuropathic PainPostoperative Pain, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedipol University

About this trial

This study aims to evaluate the efficacy of ultrasound-guided Serratus Posterior Superior (SPS) block compared to surgeon-administered intercostal blockade in preventing chronic pain at 3, 6, and 12 months following Video-Assisted Thoracoscopic Surgery (VATS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA physical status I-III.

Scheduled for elective unilateral Video-Assisted Thoracoscopic Surgery (VATS).

Disqualifiers

History of allergy to local anesthetics.

Pre-existing chronic pain syndrome or neuropathic pain.

Psychiatric disorders affecting pain assessment.

Coagulation disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPS block

    Drug

    30 mL of 0.25% Bupivacaine will be injected into the plane between the Serratus Posterior Superior muscle and the intercostal muscles at the scapular level.

  • Surgical Intercostal Blockade.

    Drug

    At the end of the operation, the surgeon will perform an injection of a total of 30 mL of 0.25% Bupivacaine into three intercostal nerves above and below the incision site under direct thoracoscopic visualization.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: SPS Block GroupExperimental treatment 1 intervention
Group B: Surgical Intercostal Blockade GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)

The primary aim is to compare incidence and severity of Chronic Post-Thoracotomy Pain with McGill Pain Questionnaire (MPQ).

Time frame
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.

Secondary outcomes

1

Opioid consumption (Fentanyl PCA)

The primary aim is to compare postoperative opioid consumption from the PCA device.

Time frame
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
2

Pain scores (Numerical rating scale-NRS)

The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded

Time frame
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
3

Need for rescue analgesia (meperidine)

The secondary aim is to compare rescue analgesia used in the postoperative 24 h.

Time frame
Postoperative 24 hours period
4

Adverse events

The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use

Time frame
Postoperative 24 hours period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

Source ClinicalTrials.gov
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