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Recruiting NCT06838793

ITPB 1 vs 3 in VATS

No phase Interventional Musculoskeletal Diseases or Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single Level Intertransverse Process Block, Three Level Intertransverse Process Block.
Who it may be relevant to
Registry conditions: Musculoskeletal Diseases or Conditions. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Quality of Recovery After Video-assisted Thoracoscopic Surgery: A Prospective, Randomised, Double-Blinded Trial Comparing Single and Three Level Intertransverse Process Block.

Overview

This study aims to evaluate the quality of recovery after video-assisted thoracoscopic surgery (VATS) by comparing the efficacy of a single-level intertransverse process block (ITPB) against a three-level ITPB, with particular attention to the quality of recovery measured by the QoR15 score at 24 hours post-surgery.

Detailed description

Video-assisted thoracoscopic surgeries (VATS) are currently the preferred technique for treating carcinoma lung. Despite being minimally invasive, VATS is associated with significant acute and chronic postoperative pain. Regional anesthetic techniques have the potential to block afferent nociception at the peripheral nerve level, the dorsal root ganglion (DRG), the thoracic sympathetic ganglion, or through a combination of these mechanisms. While the peripheral nerve block techniques such as the intercostal nerve block and serratus anterior plane block can provide analgesia for port related somatic pain, the visceral pain mediated via the thoracic sympathetic chain during VATS procedure are amenable only to epidural or paravertebral regional anaesthetic techniques. The thoracic paravertebral block (TPVB) provides ipsilateral, segmental, somatic, and sympathetic nerve blockade across multiple contiguous thoracic dermatomes and is currently the first choice for VATS. During a TPVB, the local anaesthetic (LA) is injected into the paravertebral space adjacent to the thoracic vertebra, near the intervertebral foramen.

Traditionally, TPVB is performed using either landmark or ultrasound guidance, with the LA deposited anterior to the superior costotransverse ligament (SCTL). This typically involves the block needle piercing the SCTL to reach the wedge-shaped TPVB space. While Thoracic Paravertebral Block (TPVB) is generally regarded as safe, the proximity of the needle tip to the pleura during injection poses a heightened risk of pleural puncture and pneumothorax, especially when administered by less experienced physicians. Consequently, the Erector Spinae Plane Block (ESPB) is gaining popularity as an alternative. However, it is important to note that ESPB also has its own limitations.

Recent advancements have redefined thoracic paravertebral anatomy, identifying a fat-filled retro-SCTL space located behind the SCTL. This space is farther from the pleura but remains in close proximity to anterior neural targets such as the thoracic spinal nerve, the DRG and thoracic sympathetic ganglion. It is hypothesised that an LA injection into the retro-SCTL space-referred to as the Intertransverse Process Block (ITPB) at the medial retro SCTL space-could produce a rapid onset of ipsilateral and/or bilateral segmental somatic and sympathetic nerve blockade of the thoracic dermatomes without the need to pierce the SCTL, thereby reducing the risk of pleural puncture and pneumothorax. Preliminary investigations on the ITPB for VATS is promising, however, there is a paucity of data on the effect of the number of injections following an ultrasound-guided (USG) ITPB on the analgesic efficacy, which this study aims to evaluate.

Interventions

  • Procedure Single Level Intertransverse Process Block
    Patients will then be positioned in the lateral decubitus position with the side to be blocked facing upwards, the neck slightly flexed and the upper arm resting on the pillow for the USG ITPB. The thoracic intervertebral levels (T3, T5, T7) will be identified and marked on the patient. Ultrasound gel will be applied to the skin foracoustic coupling and the transducer is placed 2-3 cm lateral to the spinous process, at the target vertebral level, in the t After obtaining the target transverse u
  • Procedure Three Level Intertransverse Process Block
    Patients will then be positioned in the lateral decubitus position with the side to be blocked facing upwards, the neck slightly flexed and the upper arm resting on the pillow for the USG ITPB. After obtaining the target transverse ultrasound window at the inferior articular process level (described above) at the T7 level, under strict aseptic precautions and local infiltration (Lignocaine 1%), a SonoTap nerve block needle (Pajunk, 22G, 80 mm, Pajunk, Geisingen, Germany) will be inserted in-plan

Primary outcome measures

  • Quality of recovery [Time frame: At 24 hours post surgery]
Secondary outcome measures (4)
  • Area under the curve for pain at rest and movement (deep breathing) [Time frame: Over the first 24 hours after surgery]
  • Number of hypoesthetic and anaesthetic dermatomes [Time frame: At 15 and 30 minutes after block completion]
  • Rescue fentanyl and phenylephrine administration [Time frame: Intraoperative]
  • Postoperative morphine, tramadol and ondansetron consumption [Time frame: At 24 and 48 hour post sugery]

Eligibility criteria

Inclusion criteria

  • ASA I-III patients
  • 18 to 80 years of age
  • Patients with primary carcinoma lung scheduled for resection under VATS procedure

Exclusion criteria

  • Patient refusal
  • Local skin infection at the area of injection
  • Coagulopathy
  • History of allergy to local anaesthetics

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Department of Anaesthesia, Pain and Perioperative Medicine, Prince of Wales Hospital, Shat — New Territories

Identifiers

NCT: NCT06838793 · 2025.547

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗