NCT07868484

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

June 4, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Erector Spinae Plane BlockMidpoint Transverse Process to Pleura BlockMTP BlockESP BlockVideo-Assisted Thoracoscopic SurgeryVATSRopivacaineFentanylPatient-Controlled AnalgesiaQuality of Recovery-15Fascial Plane Block

Outcome Measures

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.

    24 hours after surgery

Secondary Outcomes (3)

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

    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.

  • Time to first rescue analgesia

    Up to 24 hours after surgery

  • Quality of Recovery-15 (QoR-15) score

    24 +/- 2 hours after surgery

Study Arms (2)

MTP block

EXPERIMENTAL

Ultrasound-guided MTP block with ropivacaine 0.375% 20 mL single injection at T4-T5, performed under general anesthesia in the lateral decubitus position at least 15 minutes before incision. All participants also receive the same general anesthesia, ibuprofen 400 mg IV and paracetamol 1 g IV 30 minutes before wound closure, and postoperative fentanyl PCA (10 mcg/mL, demand dose 20 mcg, lockout 10 minutes, no background infusion).

Procedure: Midpoint Transverse Process to Pleura (MTP) block

ESP block

EXPERIMENTAL

Ultrasound-guided ESP block with ropivacaine 0.375% 20 mL single injection at T4-T5, performed under general anesthesia in the lateral decubitus position at least 15 minutes before incision. All participants also receive the same general anesthesia, ibuprofen 400 mg IV and paracetamol 1 g IV 30 minutes before wound closure, and postoperative fentanyl PCA (10 mcg/mL, demand dose 20 mcg, lockout 10 minutes, no background infusion).

Procedure: Erector spinae plane (ESP) block

Interventions

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).

Also known as: MTP Block
MTP block

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).

Also known as: ESP block
ESP block

Eligibility Criteria

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

You may qualify if:

  • 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
  • Able to communicate well in Indonesian, understand the use of the Numerical Rating Scale, and complete the QoR-15 questionnaire
  • Willing to participate and has signed written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RS Ngoerah

Denpasar, Bali, 80113, Indonesia

RECRUITING

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Dental OcclusionParapsychology

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Tjokorda Gde Agung Senapathi, Professor

    Udayana University

    STUDY CHAIR
  • Putu Herdita Sudiantara, Sp.An-TI

    Udayana University

    STUDY DIRECTOR

Central Study Contacts

Lalu Reza Aldira Akbar, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants receive the block after induction of general anesthesia and are unaware of the block type. All outcomes are assessed by the Acute Pain Service team, who are blinded to allocation. The block operator (consultant anesthesiologist) opens the sealed opaque randomization envelope and performs the block according to allocation, but does not assess outcomes. The block operator is not masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, parallel-group randomized trial with block randomization. Each participant receives either an ultrasound-guided MTP block or an ultrasound-guided ESP block (ropivacaine 0.375% 20 mL, single injection, T4-T5) after induction of general anesthesia.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Anesthesiology

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

June 4, 2026

Primary Completion

September 3, 2026

Study Completion

October 4, 2026

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers. The written informed consent given to participants states that their identity and medical data are kept confidential and can only be accessed by the research team and authorized parties for ethics audit. Aggregate results will be reported in the thesis and publications without participant identities.

Locations