ITPB 1 vs 3 in VATS

NCT06838793 | Recruiting

• 1 other identifier: 2025.547
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Diseases or Conditions

Keywords

Intertransverse Process Block; Video-assisted Thoracscopic Surgery; Quality of Recovery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  Comparing the quality of recovery 15 (QoR15) score at 24 hours between the study groups. QoR15: a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery)

  At 24 hours post surgery

Secondary Outcomes (4)

• Area under the curve for pain at rest and movement (deep breathing)

  Over the first 24 hours after surgery

• Number of hypoesthetic and anaesthetic dermatomes

  At 15 and 30 minutes after block completion

• Rescue fentanyl and phenylephrine administration

  Intraoperative

• Postoperative morphine, tramadol and ondansetron consumption

  At 24 and 48 hour post sugery

Study Arms (2)

Single Level Intertransverse Process Block

ACTIVE COMPARATOR

Patients with primary carcinoma lung scheduled for resection under VATS procedure and randomized in SL group will receive a single level ITPB at retro SCTL space injection and it will be performed at T5 vertebral level after which two subsequent IM sham injections with 2-3 ml 0.9% saline will be performed at T3 and T7 level.

Procedure: Single Level Intertransverse Process Block

Three Level Intertransverse Process Block

ACTIVE COMPARATOR

Patients with primary carcinoma lung scheduled for resection under VATS procedure and randomized in TL group will receive injection at T3, T5 and T7.

Procedure: Three Level Intertransverse Process Block

Interventions

Single Level Intertransverse Process Block PROCEDURE

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 ultrasound window at the articular process 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-plane and slowly advanced from a lateral to medial direction until its tip is located at the medial aspect of the retro-SCTL space. After negative heme aspiration, 25 ml of LA mixture containing 0.5% ropivacaine with 1: 200,000 adrenaline will be injected slowly in small aliquots.

Single Level Intertransverse Process Block

Three Level Intertransverse Process Block PROCEDURE

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-plane and slowly advanced from a lateral to medial direction until its tip is located at the medial aspect of the retro-SCTL space. After negative heme aspiration, 8 ml of LA mixture containing 0.5% ropivacaine with 1:200,000 adrenaline will be injected slowly in small aliquots. Subsequently, similar injections will be performed at T5 and T3 level with 8 ml and 9 ml LA mixture, respectively (Total LA mixture volume: 25 ml).

Three Level Intertransverse Process Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Anaesthesia, Pain and Perioperative Medicine, Prince of Wales Hospital, Shatin

New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Manoj K Karmakar, MD, FRCA

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayla Wong, RN, BN

CONTACT

+852 55696157; aylawong@cuhk.edu.hk

Manoj K Karmakar, MD, FRCA

CONTACT

karmakar@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 4, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

HK (1)