Regional AnesthesiaNCT05990257
CMRA for US-guided-MWA of Liver Tumors
A study testing HHB+TAPB+and LA, HHB+LA and TAPB+LA in people with Regional Anesthesia and Pain Control, run by Lu Wang at 1 site in China.
Trial summary
Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Regional Anesthesia, Pain Control, Microwave Ablation
- What is being tested?
- HHB+TAPB+and LA, HHB+LA and TAPB+LA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Primary hepatic carcinoma was considered if characterized by a solitary tumor (≤5cm in maximum diameter) or by the presence of multiple tumors (2-3 in number, each ≤3cm in maximum diameter). Importantly, these tumors were required to be devoid of vascular invasion, biliary intrusion, contiguous organ invasion, or any evidence of distant metastasis.
- Another group included in the study were patients with hepatic metastases, limited to no more than 5 tumors each measuring ≤3cm in maximum diameter.
- Furthermore, patients with hepatic hemangioma were also considered for inclusion. Specific criteria applied in these cases included tumors larger than 5cm in maximum diameter that showed considerable growth (imaging findings suggest that the diameter of the tumor has increased by more than 1cm) in the preceding two years and were associated with persistent hemangioma-related abdominal pain or discomfort. Alternatively, tumors measuring up to 5cm in maximum diameter, exhibiting a pronounced growth propensity and located at the first, second, or third hilar region in close proximity to the hilar bile duct, portal vein, hepatic artery, hepatic vein, or inferior vena cava were also considered. And all these patients cannot tolerate surgery due to other organ damage or do not want to undergo surgical treatment.
- The ASA grade is II or III.
Who cannot join
- Patients with severe underlying medical conditions that could potentially prevent them from tolerating the US-guided MWA procedure were ruled out.
- Those with tumors invading blood vessels, bile ducts, adjacent organs, or presenting with extrahepatic metastasis were also excluded.
- Further, any cases presenting with uncorrectable coagulation disorders, thrombocytopenia, or currently under administration of anticoagulant agents were deemed unfit for the study.
- Finally, patients were excluded if a safe trajectory for executing US-guided MWA was not feasible.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan cancer hospital
Chengdu, Sichuan, 610041
Lu Wang, 15828016725, 656121781@qq.com
About this study
Official title: Combined Multiple Regional Anesthesia for Microwave Ablation of Liver Tumors
Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA. Evaluative parameters included the Numerical Rating Scale (NRS) scores, consumption of morphine, incidence of complications, and factors influencing perioperative pain.
Read the detailed description
Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA.Pain levels were routinely assessed through the Numerical Rating Scale (NRS), with scores being recorded by the attending nurse every 15 minutes. The frequency of these assessments would be increased if the patient reported discomfort or if there were changes observed in vital signs. If a patient reported a pain level of ≥4 on the NRS scale, an intravenous dose of 10mg morphine was administered, provided that cardiopulmonary safety could be assured. The determination of cardiopulmonary safety was made by the interventional radiologist (M. L. with 20 years of experience). Following the ablation procedure, all patients were monitored for a period of 36 hours. During this period, several parameters were recorded at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure. These parameters included the NRS score, vital signs, any need for morphine, and the occurrence of any adverse events.
- Conditions
- Regional Anesthesia, Pain Control, Microwave Ablation, Liver Tumors
- Being tested
- HHB+TAPB+and LA, HHB+LA, TAPB+LA
- Medical subject headings
- Agnosia, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHB+TAPB+and LAProcedure or surgery
Hepatic Hilar Block (HHB), Transversus Abdominis Plane Block (TAPB), and Local Anesthesia (LA)
HHB+LAProcedure or surgery
Hepatic Hilar Block (HHB) and Local Anesthesia (LA)
TAPB+LAProcedure or surgery
Transversus Abdominis Plane Block (TAPB) and Local Anesthesia (LA)
| Study group | Role | What they receive |
|---|---|---|
| HHB+TAPB+and LA | Experimental | Group A: patients who received a HHB, TAPB, and LA Receives: Procedure: HHB+TAPB+and LA |
| HHB+LA | Experimental | Group B: patients who received HHB and LA Receives: Procedure: HHB+LA |
| TAPB+LA | Experimental | Group C: patients who received TAPB and LA Receives: Procedure: TAPB+LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain control
NRS score was used to evaluate pain control
Measured: at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jul 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Wang, Sichuan Cancer Hospital and Research Institute
- Investigators
- Man Lu, PHD, Study director, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990257
- Sponsor's protocol ID
- CMRA123
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Multiple Regional Anesthesia for Microwave Ablation of Liver Tumors
- ClinicalTrials.gov ID
- NCT05990257
- Acronym / sponsor ID
- CMRA123
- Conditions
- Regional Anesthesia, Pain Control, Microwave Ablation, Liver Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Lu WangUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Aug 2023 (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.
Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA. Evaluative parameters included the Numerical Rating Scale (NRS) scores, consumption of morphine, incidence of complications, and factors influencing perioperative pain.
Detailed description
Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA.Pain levels were routinely assessed through the Numerical Rating Scale (NRS), with scores being recorded by the attending nurse every 15 minutes. The frequency of these assessments would be increased if the patient reported discomfort or if there were changes observed in vital signs. If a patient reported a pain level of ≥4 on the NRS scale, an intravenous dose of 10mg morphine was administered, provided that cardiopulmonary safety could be assured. The determination of cardiopulmonary safety was made by the interventional radiologist (M. L. with 20 years of experience). Following the ablation procedure, all patients were monitored for a period of 36 hours. During this period, several parameters were recorded at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure. These parameters included the NRS score, vital signs, any need for morphine, and the occurrence of any adverse events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HHB+TAPB+and LA | Experimental | Procedure: HHB+TAPB+and LAGroup A: patients who received a HHB, TAPB, and LA |
| HHB+LA | Experimental | Procedure: HHB+LAGroup B: patients who received HHB and LA |
| TAPB+LA | Experimental | Procedure: TAPB+LAGroup C: patients who received TAPB and LA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary hepatic carcinoma was considered if characterized by a solitary tumor (≤5cm in maximum diameter) or by the presence of multiple tumors (2-3 in number, each ≤3cm in maximum diameter). Importantly, these tumors were required to be devoid of vascular invasion, biliary intrusion, contiguous organ invasion, or any evidence of distant metastasis.
- Another group included in the study were patients with hepatic metastases, limited to no more than 5 tumors each measuring ≤3cm in maximum diameter.
- Furthermore, patients with hepatic hemangioma were also considered for inclusion. Specific criteria applied in these cases included tumors larger than 5cm in maximum diameter that showed considerable growth (imaging findings suggest that the diameter of the tumor has increased by more than 1cm) in the preceding two years and were associated with persistent hemangioma-related abdominal pain or discomfort. Alternatively, tumors measuring up to 5cm in maximum diameter, exhibiting a pronounced growth propensity and located at the first, second, or third hilar region in close proximity to the hilar bile duct, portal vein, hepatic artery, hepatic vein, or inferior vena cava were also considered. And all these patients cannot tolerate surgery due to other organ damage or do not want to undergo surgical treatment.
- The ASA grade is II or III.
Key exclusion criteria (4 listed)
- Patients with severe underlying medical conditions that could potentially prevent them from tolerating the US-guided MWA procedure were ruled out.
- Those with tumors invading blood vessels, bile ducts, adjacent organs, or presenting with extrahepatic metastasis were also excluded.
- Further, any cases presenting with uncorrectable coagulation disorders, thrombocytopenia, or currently under administration of anticoagulant agents were deemed unfit for the study.
- Finally, patients were excluded if a safe trajectory for executing US-guided MWA was not feasible.
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 |
|---|---|---|
| HHB+TAPB+and LAHepatic Hilar Block (HHB), Transversus Abdominis Plane Block (TAPB), and Local Anesthesia (LA) | Procedure or surgery | HHB+TAPB+and LA |
| HHB+LAHepatic Hilar Block (HHB) and Local Anesthesia (LA) | Procedure or surgery | HHB+LA |
| TAPB+LATransversus Abdominis Plane Block (TAPB) and Local Anesthesia (LA) | Procedure or surgery | TAPB+LA |
Primary outcome
pain control
Time frame: at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure
NRS score was used to evaluate pain control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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. This study is not recruiting at the moment.
Man Lu, PHD study director
Sichuan Cancer Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HHB+TAPB+and LA, HHB+LA and TAPB+LA in people with Regional Anesthesia and Pain Control, run by Lu Wang at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Wang (15828016725, 656121781@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain control (time frame: at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure). 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 15 Aug 2023.