Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUdayana University

About this trial

This randomized, double-blind controlled trial compares two ultrasound-guided fascial plane blocks, the midpoint transverse process to pleura (MTP) block and the erector spinae plane (ESP) block, for postoperative analgesia in adults undergoing elective video-assisted thoracoscopic surgery (VATS) at RS Ngoerah, Denpasar, Indonesia. Both blocks are performed at the T4-T5 level after induction of general anesthesia and before skin incision, with a single injection of 20 mL ropivacaine 0.375%. Participants are randomly allocated, using block randomization and sealed opaque envelopes, to the MTP block group or the ESP block group. All participants receive the same general anesthesia, the same multimodal analgesia, and the same fentanyl patient-controlled analgesia (PCA) after surgery. The primary outcome is total fentanyl consumption via PCA in the first 24 hours after surgery. Secondary outcomes are numerical rating scale (NRS) pain scores at 0, 1, 2, 4, 6, 12 and 24 hours, time to first rescue analgesia, and Quality of Recovery-15 (QoR-15) score at 24 hours. All outcomes are assessed by the Acute Pain Service team, who are blinded to group allocation. The study tests whether the MTP block, which places local anesthetic closer to the thoracic paravertebral space, differs from the ESP block in these outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients scheduled for elective video-assisted thoracoscopic surgery (VATS) at RS Ngoerah

Age 18-65 years

ASA physical status I-III

Body mass index 18-30 kg/m2

Disqualifiers

Contraindication to regional anesthesia

Allergy to the drugs used (ropivacaine, fentanyl, paracetamol and/or ibuprofen)

Chronic chest pain for more than 2 months before surgery

Unable to be assessed with the Numerical Rating Scale and unable to operate the PCA device

Trial design

Design model

Parallel

Treatments tested in this trial

  • Midpoint Transverse Process to Pleura (MTP) block

    Procedure/Surgery

    Performed under general anesthesia in the lateral decubitus position, at least 15 minutes before surgical incision. A linear transducer (10-15 MHz) is placed parasagittally 3 cm lateral to the midline at T4-T5, and the transverse process and pleura are identified. The midpoint between the posterior edge of the transverse process and the pleura is determined. A 22G echogenic needle is advanced in-plane from cranial to caudal until the tip reaches the midpoint. After 1 mL normal saline confirms fascial separation, ropivacaine 0.375% 20 mL is injected in increments with intermittent aspiration every 5 mL. Correct placement is confirmed by fascial spread and pleural displacement on real-time ultrasound. Performed by a consultant anesthesiologist (regional analgesia).

  • Erector spinae plane (ESP) block

    Procedure/Surgery

    Performed under general anesthesia in the lateral decubitus position, at least 15 minutes before surgical incision. A linear transducer (10-15 MHz) is placed parasagittally 3 cm lateral to the midline at T4-T5, and the transverse process and the erector spinae muscle are identified. A 22G echogenic needle is advanced in-plane from caudal to cranial until the tip lies beneath the erector spinae muscle, just above the surface of the transverse process. A 1 mL normal saline injection produces the lift sign (erector spinae muscle lifted off the transverse process), then ropivacaine 0.375% 20 mL is injected gradually. Performed by a consultant anesthesiologist (regional analgesia).

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: MTP blockExperimental treatment 1 intervention
Group B: ESP blockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total fentanyl consumption via patient-controlled analgesia (PCA) in the first 24 hours after surgery

Cumulative fentanyl dose delivered through the PCA pump over the first 24 hours after surgery, read from the cumulative PCA pump log at 24 hours and expressed in mcg per kg body weight. PCA settings: fentanyl 10 mcg/mL, demand only, demand dose 20 mcg, lockout interval 10 minutes, maximum 200 mcg per 4 hours, no background infusion, identical in both groups.

Time frame
24 hours after surgery

Secondary outcomes

1

Postoperative pain intensity (Numerical Rating Scale, 0-10)

Postoperative pain intensity (Numerical Rating Scale, 0-10)

Time frame
Self-reported pain intensity on the Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable), obtained by guided interview by a blinded Acute Pain Service assessor.
2

Time to first rescue analgesia

Time in minutes from arrival at the Post-Anesthesia Care Unit (PACU) until the participant first requires rescue analgesia for pain with NRS of 4 or higher, taken from nursing records and the PCA pump log by a blinded assessor. Rescue analgesia is a 20 mcg fentanyl bolus delivered through the PCA pump. Participants who need no rescue analgesia within 24 hours are recorded as 1440 minutes.

Time frame
Up to 24 hours after surgery
3

Quality of Recovery-15 (QoR-15) score

Total score of the 15-item patient-reported Quality of Recovery questionnaire (Indonesian version), each item scored 0-10, total 0-150 (higher score = better recovery), completed by the participant and assessed by a blinded assessor.

Time frame
24 +/- 2 hours after surgery

Other outcomes

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