Liver NeoplasmsRCTNCT05531864
Ultrasound-guided Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery
A study testing Ultrasound-guided continuous low serratus anterior plane block and Ultrasound-guided single serratus anterior plane block in people with Liver Neoplasms and Postoperative Analgesia, run by Liu Di at 1 site in China.
Trial summary
To investigate the clinical application of ultrasound-guided continuous low serratus anterior plane block in open surgery for hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Neoplasms, Postoperative Analgesia, Serratus Anterior Plane Block
- What is being tested?
- Ultrasound-guided continuous low serratus anterior plane block and Ultrasound-guided single serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 29 Feb 2024
- 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
- Age 18-60 years;
- ASAI-II;
- BMI: 18-29 kg/m2
Who cannot join
- Combined cardiac, cerebral, hepatic, and renal failure;
- Comorbid psychiatric and neuromuscular disorders;
- A history of allergy to anesthetic drugs;
- Participation in other recent clinical or drug trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First People's Hospital of Neijiang
Neijiang, Sichuan
Hengchun Shen, master, 15599237557
About this study
Official title: The Role of Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery: a Randomised Clinical Trial.
To investigate the clinical application of ultrasound-guided continuous low serratus anterior plane block in open surgery for hepatocellular carcinoma.
Read the detailed description
METHODS: Patients with hepatocellular carcinoma who attended our hospital from January 2021 to April 2023 were divided into CS group and N group according to the random number table method; CS group underwent ultrasound-guided continuous low anterior serratus plane block and N group underwent ultrasound-guided single anterior serratus plane block combined with rectus abdominis sheath block; the operation time, anesthesia time, incision length, sensory block time and sensory block maintenance time were counted and recorded. Pain score (NRS) was used to detect analgesia; alanine aminotransferase (ALT), liver function aspartate aminotransferase (AST), and prothrombin time (The time of thrombin, NRS) were measured by fluorescent quantitative PCR. （The time of thrombin (APTT), total bilirubin (TBIL) levels and adverse reactions.
- Being tested
- Ultrasound-guided continuous low serratus anterior plane block, Ultrasound-guided single serratus anterior plane block
- Keywords
- serratus anterior plane block, Postoperative analgesia, liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided continuous low serratus anterior plane blockProcedure or surgery
Low anterior serratus plane block, move the mid-axillary line 4 and 5 intercostal puncture points are moved down and the puncture is changed to 7 and 8 intercostal.
Ultrasound-guided single serratus anterior plane blockProcedure or surgery
Ultrasound-guided single anterior saw plane block was performed, and a needle was injected between the 4th and 5th costals in the midaxillary line.
| Study group | Role | What they receive |
|---|---|---|
| Continuous serratus anterior plane block | Experimental | Ultrasound-guided continuous serratus anterior plane block. Receives: Procedure: Ultrasound-guided continuous low serratus anterior plane block |
| Single serratus anterior plane block combined with rectus sheath nerve block | Active comparator | Ultrasound-guided single serratus anterior plane block combined with rectus sheath nerve block. Receives: Procedure: Ultrasound-guided single serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block plane
The effect of anesthesia after ultrasound-guided nerve block was measured using planimetry, as well as the area being anesthetized. The chest wall between T2-T9 and ice cotton balls was used to assess the extent and extent of anesthesia block.
Measured: 30 minute after the surgery begins
visual analogue scale
The visual analogue scale (VAS) of the patient's pain was recorded 24 hours after operation.
Measured: 24 hours after surgery
visual analogue scale
The visual analogue scale (VAS) of the patient's pain was recorded 48 hours after operation.
Measured: 48 hours after surgery.
visual analogue scale
The visual analogue scale (VAS) of the patient's pain was recorded 36 hours after operation.
Measured: 36 hours after surgery.
Secondary outcomes (4)
Patient satisfaction
The patient's satisfaction with the analgesia 2 days after surgery was recorded. The analgesic effect: 1-3 as satisfactory, 4-6 as unsatisfactory, 7-10 as ineffective
Measured: 48 hours after surgery.
Remedial analgesic drug
Whether other analgesic drugs were added within 24 hours after operation was recorded
Measured: 24 hours after surgery.
Intraoperative blood pressure changes
Blood pressure changes were measured directly by radial artery puncture and recorded.
The changes in blood pressure and heart rate before and after excision and the use of intraoperative opioids.
Measured: 2 hours after the beginning of surgery.
Intraoperative heart rate changes
The curve of the change of the operative heart rate was recorded through the anesthesia machine.
Measured: 2 hours after the beginning of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jan 2021
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Di
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Di, The First People's Hospital of Neijiang
- Investigators
- ailing wu, Doctor, Study director, First People's Hospital of Neijiang.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531864
- Sponsor's protocol ID
- JF20PJ288
- Acronym
- RCT
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share this research plan with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery: a Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT05531864
- Acronym / sponsor ID
- RCT / JF20PJ288
- Keywords
- serratus anterior plane block, Postoperative analgesia, liver cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Liu DiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 8 Sep 2022 (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.
To investigate the clinical application of ultrasound-guided continuous low serratus anterior plane block in open surgery for hepatocellular carcinoma.
Detailed description
METHODS: Patients with hepatocellular carcinoma who attended our hospital from January 2021 to April 2023 were divided into CS group and N group according to the random number table method; CS group underwent ultrasound-guided continuous low anterior serratus plane block and N group underwent ultrasound-guided single anterior serratus plane block combined with rectus abdominis sheath block; the operation time, anesthesia time, incision length, sensory block time and sensory block maintenance time were counted and recorded. Pain score (NRS) was used to detect analgesia; alanine aminotransferase (ALT), liver function aspartate aminotransferase (AST), and prothrombin time (The time of thrombin, NRS) were measured by fluorescent quantitative PCR. （The time of thrombin (APTT), total bilirubin (TBIL) levels and adverse reactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous serratus anterior plane block | Experimental | Procedure: Ultrasound-guided continuous low serratus anterior plane blockUltrasound-guided continuous serratus anterior plane block. |
| Single serratus anterior plane block combined with rectus sheath nerve block | Active comparator | Procedure: Ultrasound-guided single serratus anterior plane blockUltrasound-guided single serratus anterior plane block combined with rectus sheath nerve block. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-60 years;
- ASAI-II;
- BMI: 18-29 kg/m2
Key exclusion criteria (4 listed)
- Combined cardiac, cerebral, hepatic, and renal failure;
- Comorbid psychiatric and neuromuscular disorders;
- A history of allergy to anesthetic drugs;
- Participation in other recent clinical or drug trials.
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 |
|---|---|---|
| Ultrasound-guided continuous low serratus anterior plane blockLow anterior serratus plane block, move the mid-axillary line 4 and 5 intercostal puncture points are moved down and the puncture is changed to 7 and 8 intercostal. | Procedure or surgery | Continuous serratus anterior plane block |
| Ultrasound-guided single serratus anterior plane blockUltrasound-guided single anterior saw plane block was performed, and a needle was injected between the 4th and 5th costals in the midaxillary line. | Procedure or surgery | Single serratus anterior plane block combined with rectus sheath nerve block |
Primary outcome
Block plane
Time frame: 30 minute after the surgery begins
The effect of anesthesia after ultrasound-guided nerve block was measured using planimetry, as well as the area being anesthetized. The chest wall between T2-T9 and ice cotton balls was used to assess the extent and extent of anesthesia block.
visual analogue scale
Time frame: 24 hours after surgery
The visual analogue scale (VAS) of the patient's pain was recorded 24 hours after operation.
visual analogue scale
Time frame: 48 hours after surgery.
The visual analogue scale (VAS) of the patient's pain was recorded 48 hours after operation.
visual analogue scale
Time frame: 36 hours after surgery.
The visual analogue scale (VAS) of the patient's pain was recorded 36 hours after operation.
4 secondary outcomes
Patient satisfaction
Time frame: 48 hours after surgery.
Remedial analgesic drug
Time frame: 24 hours after surgery.
Intraoperative blood pressure changes
Time frame: 2 hours after the beginning of surgery.
Intraoperative heart rate changes
Time frame: 2 hours after the beginning of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. We plan to share this research plan with other researchers
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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.
ailing wu, Doctor study director
First People's Hospital of Neijiang.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided continuous low serratus anterior plane block and Ultrasound-guided single serratus anterior plane block in people with Liver Neoplasms and Postoperative Analgesia, run by Liu Di 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 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 Jiang Fei (18283236053 ext. 1, 1277636690@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block plane (time frame: 30 minute after the surgery begins). The study lists 4 primary outcomes in all. 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 28 Feb 2024.