Nerve BlockEOINCT06684210
Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery
A study testing Intercostal plane block of the external oblique muscle in people with Nerve Block and Pain, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
This study intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nerve Block, Pain
- What is being tested?
- Intercostal plane block of the external oblique muscle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA Physical Status Classification of I-II Aged 18-60 years old ; Will be scheduled to undergo elective LC
Who cannot join
- Coagulation disorders, Liver/kidney disease, Abdominal surgery history, Infection in the block application area, Chronic opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery。
This study intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery.
Read the detailed description
Approved by the hospital ethics committee, 60 patients undergoing thoracic and abdominal surgery were selected in this study. They were divided into experimental group (n=30) and control group (n=30). The experimental group was given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia, and the control group was given 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia. MAP, HR and SPO2 were recorded at admission (T0), completion of induction (T1), skin incision (T2), 30min after operation (T3) and 30min after extubation (T5). The block range of nerve block in the experimental group was recorded. The VAS score and the number of patient-controlled analgesia pump were recorded 30min after extubation, 6h, 24h and 48h after operation in resting state and cough state. Postoperative adverse reactions such as respiratory depression, expectoration weakness, nausea, vomiting, and skin itching were recorded. The first time to get out of bed after operation was recorded.
- Conditions
- Nerve Block, Pain
- Being tested
- Intercostal plane block of the external oblique muscle
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal plane block of the external oblique muscleProcedure or surgery
Under ultrasound guidance, a single dose of 0.25% ropivacaine 20ml was given for bilateral intercostal muscle plane block of external oblique muscles
| Study group | Role | What they receive |
|---|---|---|
| External oblique intercostal plane block. | Experimental | Given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil + tropisetron 5mg intravenous analgesia. Receives: Procedure: Intercostal plane block of the external oblique muscle |
| Patient controlled in travenousanalgesia. | No intervention | Given intravenous analgesia with 2.0ug/kg sufentanil + tropisetron 5 mg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's postoperative pain score
Using the VIsual Analogue Scale,patients were guided to indicate the corresponding pain score according to their own pain situation, and the score ranged from 0 to 10. To evaluate the degree of postoperative pain, a score of 0 indicates no pain at all, a score of 2 indicates mild pain, and a score of 10 indicates the most severe pain, with higher scores indicating more severe pain
Measured: Extubation for 30minutes, 6 hours after surgery, 24 hours after surgery, and 48 hours after surgery
Secondary outcomes (3)
Changes in blood pressure
Mean arterial pressure at different time points.Mean arterial pressure will be reported in mmHg.
Measured: Perioperative period
Changes in heart rate
Heart rate at different time points.Heart rate will be reported in counts per minute.
Measured: Perioperative period
Extent of action of external oblique intercostal muscle plane block
The specific extent of action of the external oblique muscle intercostal muscle plane block in the thoracoabdominal wall.
Measured: Ten minutes after the nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684210
- Sponsor's protocol ID
- WCX123456
- Acronym
- EOI
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery。
- ClinicalTrials.gov ID
- NCT06684210
- Acronym / sponsor ID
- EOI / WCX123456
- Conditions
- Nerve Block, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 Nov 2024 (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 intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery.
Detailed description
Approved by the hospital ethics committee, 60 patients undergoing thoracic and abdominal surgery were selected in this study. They were divided into experimental group (n=30) and control group (n=30). The experimental group was given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia, and the control group was given 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia. MAP, HR and SPO2 were recorded at admission (T0), completion of induction (T1), skin incision (T2), 30min after operation (T3) and 30min after extubation (T5). The block range of nerve block in the experimental group was recorded. The VAS score and the number of patient-controlled analgesia pump were recorded 30min after extubation, 6h, 24h and 48h after operation in resting state and cough state. Postoperative adverse reactions such as respiratory depression, expectoration weakness, nausea, vomiting, and skin itching were recorded. The first time to get out of bed after operation was recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External oblique intercostal plane block. | Experimental | Procedure: Intercostal plane block of the external oblique muscleGiven 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil + tropisetron 5mg intravenous analgesia. |
| Patient controlled in travenousanalgesia. | No intervention | –Given intravenous analgesia with 2.0ug/kg sufentanil + tropisetron 5 mg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA Physical Status Classification of I-II Aged 18-60 years old ; Will be scheduled to undergo elective LC
Key exclusion criteria (1 listed)
- Coagulation disorders, Liver/kidney disease, Abdominal surgery history, Infection in the block application area, Chronic opioid use.
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 |
|---|---|---|
| Intercostal plane block of the external oblique muscleUnder ultrasound guidance, a single dose of 0.25% ropivacaine 20ml was given for bilateral intercostal muscle plane block of external oblique muscles | Procedure or surgery | External oblique intercostal plane block. |
Primary outcome
Patient's postoperative pain score
Time frame: Extubation for 30minutes, 6 hours after surgery, 24 hours after surgery, and 48 hours after surgery
Using the VIsual Analogue Scale,patients were guided to indicate the corresponding pain score according to their own pain situation, and the score ranged from 0 to 10. To evaluate the degree of postoperative pain, a score of 0 indicates no pain at all, a score of 2 indicates mild pain, and a score of 10 indicates the most severe pain, with higher scores indicating more severe pain
3 secondary outcomes
Changes in blood pressure
Time frame: Perioperative period
Changes in heart rate
Time frame: Perioperative period
Extent of action of external oblique intercostal muscle plane block
Time frame: Ten minutes after the nerve block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intercostal plane block of the external oblique muscle in people with Nerve Block and Pain, run by The First Hospital of Qinhuangdao 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's postoperative pain score (time frame: Extubation for 30minutes, 6 hours after surgery, 24 hours after surgery, and 48 hours after 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 12 Nov 2024.