Musculoskeletal Diseases or ConditionsNCT06838793
ITPB 1 vs 3 in VATS
A study testing Single Level Intertransverse Process Block and Three Level Intertransverse Process Block in people with Musculoskeletal Diseases or Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Single Level Intertransverse Process Block and Three Level Intertransverse Process Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients
- 18 to 80 years of age
- Patients with primary carcinoma lung scheduled for resection under VATS procedure
Who cannot join
- Patient refusal
- Local skin infection at the area of injection
- Coagulopathy
- History of allergy to local anaesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manoj K Karmakar, MD, FRCA contact
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Anaesthesia, Pain and Perioperative Medicine, Prince of Wales Hospital, Shatin
New Territories
Ayla Wong, RN, BN, +852 55696157, aylawong@cuhk.edu.hk
About this study
Official title: Quality of Recovery After Video-assisted Thoracoscopic Surgery: A Prospective, Randomised, Double-Blinded Trial Comparing Single and Three Level Intertransverse Process Block.
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.
Read the 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.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Single Level Intertransverse Process Block, Three Level Intertransverse Process Block
- Keywords
- Intertransverse Process Block, Video-assisted Thoracscopic Surgery, Quality of Recovery
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Level Intertransverse Process BlockProcedure or surgery
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.
Three Level Intertransverse Process BlockProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Three Level Intertransverse Process Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 24 hours post surgery
Secondary outcomes (4)
Area under the curve for pain at rest and movement (deep breathing)
Comparing the area under the curve (AUC) of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing (pain burden).
Measured: Over the first 24 hours after surgery
Number of hypoesthetic and anaesthetic dermatomes
Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax
Measured: At 15 and 30 minutes after block completion
Rescue fentanyl and phenylephrine administration
Total rescue fentanyl and phenylephrine administration
Measured: Intraoperative
Postoperative morphine, tramadol and ondansetron consumption
Total postoperative morphine, tramadol and ondansetron consumption
Measured: At 24 and 48 hour post sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start4 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Diseases or ConditionsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Manoj K Karmakar, Chinese University of Hong Kong
- Investigators
- Manoj K Karmakar, MD, FRCA, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838793
- Sponsor's protocol ID
- 2025.547
- Status last verified
- Apr 2025
- First submitted
- 17 Feb 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery After Video-assisted Thoracoscopic Surgery: A Prospective, Randomised, Double-Blinded Trial Comparing Single and Three Level Intertransverse Process Block.
- ClinicalTrials.gov ID
- NCT06838793
- Acronym / sponsor ID
- 2025.547
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- Intertransverse Process Block, Video-assisted Thoracscopic Surgery, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Level Intertransverse Process Block | Active comparator | Procedure: Single Level Intertransverse Process BlockPatients 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. |
| Three Level Intertransverse Process Block | Active comparator | Procedure: Three Level Intertransverse Process BlockPatients with primary carcinoma lung scheduled for resection under VATS procedure and randomized in TL group will receive injection at T3, T5 and T7. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III patients
- 18 to 80 years of age
- Patients with primary carcinoma lung scheduled for resection under VATS procedure
Key exclusion criteria (4 listed)
- Patient refusal
- Local skin infection at the area of injection
- Coagulopathy
- History of allergy to local anaesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Level Intertransverse Process BlockPatients 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. | Procedure or surgery | Single Level Intertransverse Process Block |
| Three Level Intertransverse Process BlockPatients 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). | Procedure or surgery | Three Level Intertransverse Process Block |
Primary outcome
Quality of recovery
Time frame: At 24 hours post surgery
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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manoj K Karmakar, MD, FRCA contact
Manoj K Karmakar, MD, FRCA principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Level Intertransverse Process Block and Three Level Intertransverse Process Block in people with Musculoskeletal Diseases or Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayla Wong, RN, BN (+852 55696157, aylawong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (time frame: At 24 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.