AnesthesiaNCT04581616
The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery
A study testing Intrathoracic Intercostal Nerve Block and Erector Spinae Plane Block in people with Anesthesia and Postoperative Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to compare the effect of ultrasound-guided erector spinae plane block and interthoracic intercostal nerve block in thoracic surgery. Interthoracic intercostal nerve block is a routine procedure during the surgery by the surgeon in our hospital, and ultrasound-guide erector spinae plane block is a… Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Postoperative Pain, Ultrasound Therapy; Complications
- What is being tested?
- Intrathoracic Intercostal Nerve Block and Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Oct 2020to 16 Oct 2022
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient receive thoracic surgery
- BMI between 18.5~30.0 kg.m-2
Who cannot join
- Pregnant woman
- Patient with any one of following chronic organ dysfunction: Heart failure (NYHA score =III、IV); Renal failure (eGFR< 60 ml.min-1.1.73m-2)
- Arrhythmia
- Ongoing infection or septic patient
- Chronic use of analgesic with addiction
- Coagulopathy that is not suitable for regional anesthesia performance
- Thoracic surgery that is not suitable for placement of endotracheal blocker tube
- Redo surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the effect of ultrasound-guided erector spinae plane block and interthoracic intercostal nerve block in thoracic surgery. Interthoracic intercostal nerve block is a routine procedure during the surgery by the surgeon in our hospital, and ultrasound-guide erector spinae plane block is a relative new developed regional analgesia technique introduced since 2016 and mainly done by anesthesiologists. Both technique provide analgesic effect to some extent and reduce opiate consumption and side effects. However, no previous literature or research compare the effect of these two technique in thoracic surgery. The primary endpoint of our study is compare morphine consumption and pain score between patients undergo ESP block and patients undergo ICNB after thoracic surgery; the second endpoint is to compare the recovery condition evaluated by QoR-15 questionaire 24 hours after surgery.
Read the detailed description
Sample size estimation is based on our APS team data, in which the average cumulative morphine consumption in patients underwent VATS surgery with ICNB was calculated. The mean cumulative morphine consumption was 15±8 mg of patients underwent VATS with ICNB. We assume the difference between ICNB and ESPB group reach 5 mg and aim for a power of 95 % and a risk of 0.05 for a type-1 error, at least 42 for each group needing to be recruited. 50 patients for each group, total 100 patients will be collected to avoid dropouts. Patient will be allocated to one of the trial groups using a computer-generated random number table once the consent was approved. First group is ICNB group and the second group is ESPB group.
The general anesthesia agents, induction process and routine care are the same for both groups. Once aforementioned routine cares are done, the patient will be turn into lateral decubitus position. Echo-guided ESP block will be performed after patients are turned into lateral decubitus position in ESP group; on the other side, local anesthetics will be injected at incision site and intrathoracic intercostal nerve block will be performed in ICNB group right after the surgeon makes the incision site and get into chest cavity.
Pain score (VAS) and cumulative morphine consumption will be recorded in PACU, postoperative 24H, 48H, and before discharge. Recovery condition will be evaluated via QoR-15 questionnaire in postoperative 24H, furthermore, we will follow up the patient's pain and recovery status 3 months after the operation. After collecting above data, the effect of ESP group and ICNB group on acute pain relieve, chronic pain control and recovery enhancement will be evaluated.
- Being tested
- Intrathoracic Intercostal Nerve Block, Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, ESPB, Intercostal Nerve Block, ICNB, Thoracic surgery, Postoperative pain, Quality of recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathoracic Intercostal Nerve BlockProcedure or surgery
Also called ICNB
Injection of local anesthetic into the subcostal groove, to achieve analgesia for chest region.
Erector Spinae Plane BlockProcedure or surgery
Also called ESPB
Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve analgesia for chest region.
| Study group | Role | What they receive |
|---|---|---|
| ICNB group | Active comparator | After patient was turned to lateral decubitus position, local anesthetics is injected around incision site and ICNB is performed once after surgeon geys into chest cavity. Receives: Procedure: Intrathoracic Intercostal Nerve Block |
| ESPB group | Experimental | After patient was turned to lateral decubitus position, ESPB is performed via ultrasound guided technique before sound incision. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensities in two category, namely static and dynamic, gauged by a 0-100 mm visual analogue scale, (no pain to severe pain)
Measured: Postoperative 48 hours
Postoperative analgesic consumption
Cumulative morphine consumption in postoperative two days
Measured: Postoperative 48 hours
Secondary outcomes (1)
Recovery quality: questionnaire
Postoperative recovery quality assessed by Quality of recovery-15 (QoR-15) questionnaire, with a score range of 0-150, (poor recovery to excellent recovery)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start16 Oct 2020
- Primary completion16 Oct 2022
- Study completion16 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581616
- Sponsor's protocol ID
- 202008040RINC
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 6 May 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04581616
- Acronym / sponsor ID
- 202008040RINC
- Keywords
- Erector Spinae Plane Block, ESPB, Intercostal Nerve Block, ICNB, Thoracic surgery, Postoperative pain, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 16 Oct 2022 (actual)
- First posted
- 9 Oct 2020 (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 aims to compare the effect of ultrasound-guided erector spinae plane block and interthoracic intercostal nerve block in thoracic surgery. Interthoracic intercostal nerve block is a routine procedure during the surgery by the surgeon in our hospital, and ultrasound-guide erector spinae plane block is a relative new developed regional analgesia technique introduced since 2016 and mainly done by anesthesiologists. Both technique provide analgesic effect to some extent and reduce opiate consumption and side effects. However, no previous literature or research compare the effect of these two technique in thoracic surgery. The primary endpoint of our study is compare morphine consumption and pain score between patients undergo ESP block and patients undergo ICNB after thoracic surgery; the second endpoint is to compare the recovery condition evaluated by QoR-15 questionaire 24 hours after surgery.
Detailed description
Sample size estimation is based on our APS team data, in which the average cumulative morphine consumption in patients underwent VATS surgery with ICNB was calculated. The mean cumulative morphine consumption was 15±8 mg of patients underwent VATS with ICNB. We assume the difference between ICNB and ESPB group reach 5 mg and aim for a power of 95 % and a risk of 0.05 for a type-1 error, at least 42 for each group needing to be recruited. 50 patients for each group, total 100 patients will be collected to avoid dropouts. Patient will be allocated to one of the trial groups using a computer-generated random number table once the consent was approved. First group is ICNB group and the second group is ESPB group.
The general anesthesia agents, induction process and routine care are the same for both groups. Once aforementioned routine cares are done, the patient will be turn into lateral decubitus position. Echo-guided ESP block will be performed after patients are turned into lateral decubitus position in ESP group; on the other side, local anesthetics will be injected at incision site and intrathoracic intercostal nerve block will be performed in ICNB group right after the surgeon makes the incision site and get into chest cavity.
Pain score (VAS) and cumulative morphine consumption will be recorded in PACU, postoperative 24H, 48H, and before discharge. Recovery condition will be evaluated via QoR-15 questionnaire in postoperative 24H, furthermore, we will follow up the patient's pain and recovery status 3 months after the operation. After collecting above data, the effect of ESP group and ICNB group on acute pain relieve, chronic pain control and recovery enhancement will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICNB group | Active comparator | Procedure: Intrathoracic Intercostal Nerve BlockAfter patient was turned to lateral decubitus position, local anesthetics is injected around incision site and ICNB is performed once after surgeon geys into chest cavity. |
| ESPB group | Experimental | Procedure: Erector Spinae Plane BlockAfter patient was turned to lateral decubitus position, ESPB is performed via ultrasound guided technique before sound incision. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient receive thoracic surgery
- BMI between 18.5~30.0 kg.m-2
Key exclusion criteria (8 listed)
- Pregnant woman
- Patient with any one of following chronic organ dysfunction: Heart failure (NYHA score =III、IV); Renal failure (eGFR< 60 ml.min-1.1.73m-2)
- Arrhythmia
- Ongoing infection or septic patient
- Chronic use of analgesic with addiction
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 |
|---|---|---|
| Intrathoracic Intercostal Nerve BlockAlso: ICNBInjection of local anesthetic into the subcostal groove, to achieve analgesia for chest region. | Procedure or surgery | ICNB group |
| Erector Spinae Plane BlockAlso: ESPBInjection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve analgesia for chest region. | Procedure or surgery | ESPB group |
Primary outcome
Pain intensity
Time frame: Postoperative 48 hours
Pain intensities in two category, namely static and dynamic, gauged by a 0-100 mm visual analogue scale, (no pain to severe pain)
Postoperative analgesic consumption
Time frame: Postoperative 48 hours
Cumulative morphine consumption in postoperative two days
1 secondary outcome
Recovery quality: questionnaire
Time frame: Postoperative 24 hours
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 6 May 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.
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 Intrathoracic Intercostal Nerve Block and Erector Spinae Plane Block in people with Anesthesia and Postoperative Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 8 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 6 May 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 Taiwan. 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?
Pain intensity (time frame: Postoperative 48 hours). The study lists 2 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 6 May 2023.