HepatectomyITPB QoRNCT06957041
Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy
A study testing Intertransverse process block in people with Hepatectomy and Intertransverse Process Block, run by Chinese University of Hong Kong.
Trial summary
The study aims to assess the analgesic efficacy of the ITPB at the retro-SCTL space in patients undergoing major open hepatectomy surgery. This is assessed by: Primary Objective: Primary outcome measure: ● Assessing the quality of recovery 15 (QoR15) score at 24 and 48 hours Secondary outcome measure: Number of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatectomy, Intertransverse Process Block, Quality of Recovery (QoR-15)
- What is being tested?
- Intertransverse process block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-75 years of ASA I - III physical status classification undergoing open hepatectomy for benign or malignant liver lesion.
Who cannot join
- Patient refusal
- Patients who are unable to comprehend the QoR15 form
- Local or systemic infection
- Coagulopathy leading to absolute contraindication to regional anesthesia
- Contraindication to local anaesthetics (LA) such as LA allergy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Intertransverse Process Block on the Quality of Recovery Post-Open Hepatectomy: A Pilot Non-Randomised Study of Intervention
The study aims to assess the analgesic efficacy of the ITPB at the retro-SCTL space in patients undergoing major open hepatectomy surgery. This is assessed by:
Primary Objective:
Read more
Primary outcome measure:
● Assessing the quality of recovery 15 (QoR15) score at 24 and 48 hours
Secondary outcome measure:
- Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge
- Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow.
- Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours
- Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU)
Hypothesis:
The investigators hypothesize that the application of ITPB targeting the retro-SCTL space in patients undergoing open hepatectomy will improve overall quality of recovery and pain score.
- Being tested
- Intertransverse process block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intertransverse process blockProcedure or surgery
The patient(s) will receive a pre-induction Intertransverse process block as pilot study
| Study group | Role | What they receive |
|---|---|---|
| Open Hepatectomy Patient receiving the intertransverse process block | Experimental | Not described Receives: Procedure: Intertransverse process block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QOR-15)
The QoR-15 scale is a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR). The QoR-15 has since become the most widely reported measure of patient-assessed QoR after surgery. QoR-15 has no units.
Measured: 24 and 48 hours
Secondary outcomes (4)
Dermatomal blockade on Thorax 30 minutes upon block completion
To assess the number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge. This will be done by ice block test. The blockade is considered positive if patient has a reduction in cold sensation over the tested dermatome compared to non-blocked areas such as forehead.
Measured: Up to 30 minutes after block completion
24 hours area under curve of postoperative pain score
Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow.
Measured: Up to 24 hours
Morphine consumption at 24 and 48 hours postoperatively
Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours
Measured: At 24 and 48 hours postoperatively
Time to discharge from HDU / ICU
Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU) up to 5 days
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wing Sum Li, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957041
- Sponsor's protocol ID
- CRE Ref. No. 2024.562
- Acronym
- ITPB QoR
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intertransverse Process Block on the Quality of Recovery Post-Open Hepatectomy: A Pilot Non-Randomised Study of Intervention
- ClinicalTrials.gov ID
- NCT06957041
- Acronym / sponsor ID
- ITPB QoR / CRE Ref. No. 2024.562
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 May 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.
The study aims to assess the analgesic efficacy of the ITPB at the retro-SCTL space in patients undergoing major open hepatectomy surgery. This is assessed by:
Primary Objective:
Primary outcome measure:
● Assessing the quality of recovery 15 (QoR15) score at 24 and 48 hours
Secondary outcome measure:
- Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge
- Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow.
- Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours
- Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU)
Hypothesis:
The investigators hypothesize that the application of ITPB targeting the retro-SCTL space in patients undergoing open hepatectomy will improve overall quality of recovery and pain score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Hepatectomy Patient receiving the intertransverse process block | Experimental | Procedure: Intertransverse process block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 18-75 years of ASA I - III physical status classification undergoing open hepatectomy for benign or malignant liver lesion.
Key exclusion criteria (5 listed)
- Patient refusal
- Patients who are unable to comprehend the QoR15 form
- Local or systemic infection
- Coagulopathy leading to absolute contraindication to regional anesthesia
- Contraindication to local anaesthetics (LA) such as LA allergy
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 |
|---|---|---|
| Intertransverse process blockThe patient(s) will receive a pre-induction Intertransverse process block as pilot study | Procedure or surgery | Open Hepatectomy Patient receiving the intertransverse process block |
Primary outcome
Quality of Recovery (QOR-15)
Time frame: 24 and 48 hours
The QoR-15 scale is a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR). The QoR-15 has since become the most widely reported measure of patient-assessed QoR after surgery. QoR-15 has no units.
4 secondary outcomes
Dermatomal blockade on Thorax 30 minutes upon block completion
Time frame: Up to 30 minutes after block completion
24 hours area under curve of postoperative pain score
Time frame: Up to 24 hours
Morphine consumption at 24 and 48 hours postoperatively
Time frame: At 24 and 48 hours postoperatively
Time to discharge from HDU / ICU
Time frame: Up to 5 days
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 4 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intertransverse process block in people with Hepatectomy and Intertransverse Process Block, run by Chinese University of 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Wing Sum Li, MBChB, BA (852-55699340, vickiliwingsum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (QOR-15) (time frame: 24 and 48 hours). 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 4 May 2025.