Thoracic Surgical ProceduresNCT03937076
Efficacy of Intercostal Block Versus Pectoral Nerve Block II
A study testing PECS II block in people with Thoracic Surgical Procedures, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The investigators will evaluate the efficacy of two types of pain control blocks in patients going thoracoscopic surgery. Patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgical Procedures
- What is being tested?
- PECS II block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2019to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for video assisted thoracoscopic surgery
- Over 18 years of age
- No known allergy to Bupivacaine
- Candidate who can read, understand and sign inform consent
Who cannot join
- Candidate had previous surgery at the same side
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical center
Haifa, 34362
Dan LEVY FABER, MD, 97248250646, DANLf@clalit.org.il
Firhas Darwshe, MD, 97248250289, FirasDa@clalit.org.il
About this study
Official title: Efficacy of Intercostal Block Versus Pectoral Nerve Block II in Controlling Acute Post-surgical Pain in Thoracoscopic Surgery
The investigators will evaluate the efficacy of two types of pain control blocks in patients going thoracoscopic surgery. Patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. This group represents the existent treating policy.
In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen. The investigators hope to find which pain control block is superior.
Read the detailed description
Thoracic operations are among the most post-operative painful surgeries. Without a doubt, the emergence of the thoracoscopic approaches has decreased pain severity. The classical methods of pain control that is used in the open thoracic procedures are not suitable in the thoracoscopic milieu. As such, pain control methods should be examined. The most accepted methods are those using different anesthetic blocks based on local anesthetic (Bupivacaine), whether in intercostal block or paravertebral one. Today the investigators use intercostal block consistently in thoracospoic procedures.
Recently, the use of the pectoral nerve block (Pecs II) has emerged for different chest wall surgeries, which has proved to be helpful. As a consequence,the investigators want to examine the efficiency of this block in the control of postoperative pain after thoracoscopic procedures.
In this prospective comparative study, patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. This group represents the existent treating policy.
In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen.
The follow up will include checking the pain level in the postoperative days, the extent of the pain relief medication until the discharge, and patient evaluation at the first post-discharge inspection.
The study will include 40 patients in each arm, which will be older than 18 years without gender limitations. This study will not include people with special demands.
Main inclusion criteria: patients planned for thoracoscopic procedures in the investigators department, capable of understanding, reading and signing on the consent form.
Main exclusion criteria: re-operation in the early post-operative period, re-operation at the same side, a known allergy to BUPIVACAINE.
In the case of conversion from thoracoscopic to open approach, patients will be expelled from the study.
The block will be performed solely by the surgeon or the anesthesiologist. Follow-up period will include the postoperative hospitalization period until the first post-discharge inspection.
- Conditions
- Thoracic Surgical Procedures
- Being tested
- PECS II block
- Keywords
- Intercostal block, Pectoral nerve block II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS II blockProcedure or surgery
Pectoral muscles Nerve block for postsurgical pain, PECS II, based on BUPIVACAINE:
Pectoral muscles nerve block is a procedure in which local anesthetic is injected into two sites.
- between the major and minor pectoral muscles, in order to anesthetize the lateral and medial nerve. This injection is referred to as PECS I block.
- between the minor pectoral muscle and the anterior serratus muscle, in order to anesthetize the intercostal nerves.
| Study group | Role | What they receive |
|---|---|---|
| intercostal block | No intervention | patients will get intercostal block at the end of the surgery, control group |
| PECS II block | Experimental | patients with get PECS II block at the end of the surgery, research group Receives: Procedure: PECS II block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of pain medications after surgery
The amount of pain medications used by each participant in the post surgical period
Measured: from the end of surgery until participant hospital release, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jun 2019
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgical ProceduresStudies 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
- Model description
- patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Levy Faber, Carmel Medical Center
- Investigators
- Dan LEVY FABER, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937076
- Sponsor's protocol ID
- CMC-18-0191-CTIL
- Status last verified
- Jul 2019
- First submitted
- 1 May 2019
- Last updated
- 24 Jul 2019
- 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intercostal Block Versus Pectoral Nerve Block II in Controlling Acute Post-surgical Pain in Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03937076
- Acronym / sponsor ID
- CMC-18-0191-CTIL
- Conditions
- Thoracic Surgical Procedures
- Keywords
- Intercostal block, Pectoral nerve block II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 3 May 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.
The investigators will evaluate the efficacy of two types of pain control blocks in patients going thoracoscopic surgery. Patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. This group represents the existent treating policy.
In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen. The investigators hope to find which pain control block is superior.
Detailed description
Thoracic operations are among the most post-operative painful surgeries. Without a doubt, the emergence of the thoracoscopic approaches has decreased pain severity. The classical methods of pain control that is used in the open thoracic procedures are not suitable in the thoracoscopic milieu. As such, pain control methods should be examined. The most accepted methods are those using different anesthetic blocks based on local anesthetic (Bupivacaine), whether in intercostal block or paravertebral one. Today the investigators use intercostal block consistently in thoracospoic procedures.
Recently, the use of the pectoral nerve block (Pecs II) has emerged for different chest wall surgeries, which has proved to be helpful. As a consequence,the investigators want to examine the efficiency of this block in the control of postoperative pain after thoracoscopic procedures.
In this prospective comparative study, patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. This group represents the existent treating policy.
In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen.
The follow up will include checking the pain level in the postoperative days, the extent of the pain relief medication until the discharge, and patient evaluation at the first post-discharge inspection.
The study will include 40 patients in each arm, which will be older than 18 years without gender limitations. This study will not include people with special demands.
Main inclusion criteria: patients planned for thoracoscopic procedures in the investigators department, capable of understanding, reading and signing on the consent form.
Main exclusion criteria: re-operation in the early post-operative period, re-operation at the same side, a known allergy to BUPIVACAINE.
In the case of conversion from thoracoscopic to open approach, patients will be expelled from the study.
The block will be performed solely by the surgeon or the anesthesiologist. Follow-up period will include the postoperative hospitalization period until the first post-discharge inspection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen.
| Arm | Type | Receives |
|---|---|---|
| intercostal block | No intervention | –patients will get intercostal block at the end of the surgery, control group |
| PECS II block | Experimental | Procedure: PECS II blockpatients with get PECS II block at the end of the surgery, research group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidate for video assisted thoracoscopic surgery
- Over 18 years of age
- No known allergy to Bupivacaine
- Candidate who can read, understand and sign inform consent
Key exclusion criteria (1 listed)
- Candidate had previous surgery at the same side
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 |
|---|---|---|
| PECS II blockPectoral muscles Nerve block for postsurgical pain, PECS II, based on BUPIVACAINE: Pectoral muscles nerve block is a procedure in which local anesthetic is injected into two sites. 1. between the major and minor pectoral muscles, in order to anesthetize the lateral and medial nerve. This injection is referred to as PECS I block. 2. between the minor pectoral muscle and the anterior serratus muscle, in order to anesthetize the intercostal nerves. | Procedure or surgery | PECS II block |
Primary outcome
The use of pain medications after surgery
Time frame: from the end of surgery until participant hospital release, assessed up to 4 weeks
The amount of pain medications used by each participant in the post surgical period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
Dan LEVY FABER, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECS II block in people with Thoracic Surgical Procedures, run by Carmel Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 24 Jul 2019. 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 Israel. 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 Dan LEVY FABER, MD (97248250289, DANLf@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The use of pain medications after surgery (time frame: from the end of surgery until participant hospital release, assessed up to 4 weeks). 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 24 Jul 2019.