Pain, PostoperativeNCT03839160
The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study
A study testing Serratus anterior plane block in people with Pain, Postoperative and Anesthesia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Thoracotomy
- What is being tested?
- Serratus anterior plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 May 2021
- 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 I-II
- BMI 18-28kg/m2
- Wedge incision and lobectomy
Who cannot join
- Uncontrolled hypertension or chronic conditions
- History of opioid dependence
- Allergy to bupivacaine hydrochloride
- Severe bleeding during operation or post operation
- Inability to communicate with investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Serratus Anterior Plane Block in Analgesia for Thoracotomy: a Prospective Study
Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.
Read the detailed description
Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain, yet more evidence is needed to ascertain its efficacy.
This is a prospective study carried out in a tertiary hospital. Patients scheduled for thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of opioids-related side effects and length of hospital stay are documented. The primary objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to compare the opioids-related side effects (including nausea, vomiting and pruritus), hemodynamic parameters and the length of hospital stay.
- Conditions
- Pain, Postoperative, Anesthesia, Thoracotomy
- Being tested
- Serratus anterior plane block, Intravenous patient-controlled-analgesia morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior plane blockProcedure or surgery
Also called Serratus plane block
Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.
Intravenous patient-controlled-analgesia morphineDrug
Also called PCIA
Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
| Study group | Role | What they receive |
|---|---|---|
| SAPB group. Group S | Active comparator | In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time. Receives: Procedure: Serratus anterior plane block; Drug: Intravenous patient-controlled-analgesia morphine |
| Control group. Group C | Placebo comparator | In this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time. Receives: Drug: Intravenous patient-controlled-analgesia morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Adult Pain Visual Analog Scale
Measured: Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary outcomes (6)
Hemodynamic profile - Heart rate
Heart rate
Measured: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Hemodynamic profile - blood pressure
blood pressure
Measured: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Hemodynamic profile - SpO2
SpO2
Measured: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Opioids-related side effects - nausea
nausea
Measured: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Catheter-related profile
The position of the catheter tip and the level of blockade
Measured: at Day 1, Day2 and Day 3 post-operation
Morphine consumption
Morphine consumption
Measured: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Cang, MD, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839160
- Sponsor's protocol ID
- truncal block SAPB
- Status last verified
- May 2021
- First submitted
- 23 Nov 2017
- Last updated
- 13 May 2021
- 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 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Serratus Anterior Plane Block in Analgesia for Thoracotomy: a Prospective Study
- ClinicalTrials.gov ID
- NCT03839160
- Acronym / sponsor ID
- truncal block SAPB
- Conditions
- Pain, Postoperative, Anesthesia, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 15 Feb 2019 (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.
Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.
Detailed description
Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain, yet more evidence is needed to ascertain its efficacy.
This is a prospective study carried out in a tertiary hospital. Patients scheduled for thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of opioids-related side effects and length of hospital stay are documented. The primary objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to compare the opioids-related side effects (including nausea, vomiting and pruritus), hemodynamic parameters and the length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAPB group. Group S | Active comparator | Procedure: Serratus anterior plane block, Drug: Intravenous patient-controlled-analgesia morphineIn this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time. |
| Control group. Group C | Placebo comparator | Drug: Intravenous patient-controlled-analgesia morphineIn this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II
- BMI 18-28kg/m2
- Wedge incision and lobectomy
Key exclusion criteria (5 listed)
- Uncontrolled hypertension or chronic conditions
- History of opioid dependence
- Allergy to bupivacaine hydrochloride
- Severe bleeding during operation or post operation
- Inability to communicate with investigators.
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 |
|---|---|---|
| Serratus anterior plane blockAlso: Serratus plane blockSerratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr. | Procedure or surgery | SAPB group. Group S |
| Intravenous patient-controlled-analgesia morphineAlso: PCIAMorphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time. | Drug | Control group. Group C, SAPB group. Group S |
Primary outcome
visual analog scale
Time frame: Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Adult Pain Visual Analog Scale
6 secondary outcomes
Hemodynamic profile - Heart rate
Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Hemodynamic profile - blood pressure
Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Hemodynamic profile - SpO2
Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Opioids-related side effects - nausea
Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Catheter-related profile
Time frame: at Day 1, Day2 and Day 3 post-operation
Morphine consumption
Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
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 13 May 2021.
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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.
Jing Cang, MD study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus anterior plane block in people with Pain, Postoperative and Anesthesia, run by Shanghai Zhongshan Hospital 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 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: finished, as of the sponsor's last update on 13 May 2021. 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. Some participants in this study may receive a placebo. 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?
visual analog scale (time frame: Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation). 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 13 May 2021.