AnesthesiaPhase 2NCT03023982
Pectoralis and Serratus Nerves Block in Thoracic Surgery
A Phase 2 study testing Bupivacaine Hydrochloride, Ultrasound and Thoracotomy in people with Anesthesia and Surgery, run by Soroka University Medical Center.
Trial summary
A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgery, Block
- What is being tested?
- Bupivacaine Hydrochloride, Ultrasound and Thoracotomy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Feb 2019
- Phase
- Phase 2
- 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
- All patients undergoing thoracic surgery, older ≥18 years
- Patients who meet criteria of ASA I-II-III class.
Who cannot join
- Patients who will be unconscious or mentally incompetent
- Patients refusal to participate in the study
- ASA -IV -V
- Patient with coagulopathy
- Hemodynamically unstable (systolic BP < 90, HR > 100)
- Allergy to local anesthetic drugs or opioids
- Pregnant patient
- History of opioid abuse
About this study
Official title: Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery
A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall
Read the detailed description
The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral prosthesis for pain control management.
This block is provided by injection into another myofascial plane, this time between pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block is simple in performance with a high success rate and minimal incidence of complications, especially, if used ultrasound approach that gives a good understanding of anatomy of the lateral thoracic wall.
In present clinical trial we are going to compare PECs block for pain control with traditional pain management techniques based on IV opioids and NSAIDs treatment in patient undergoing thoracic surgery in early postoperative period.
- Conditions
- Anesthesia, Surgery, Block, Thoracic Injury
- Being tested
- Bupivacaine Hydrochloride, Ultrasound, Thoracotomy, Opioids, NSAID
- Medical subject headings
- Bites and Stings, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called Marcaine
40 cc 0.25% of Bupivacaine Hydrochloride injection using ultrasound approach will be administered between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib
UltrasoundDevice
Also called Sonosite
All blocks will be done under ultrasound
ThoracotomyProcedure or surgery
The patient population will include patients that undergo either open thoracotomy or thoracoscopy for anatomic and non-anatomic lung resection. The standard thoracoscopy approach in our institute includes three holes technic. There are two incisions of 1 cm and utility incision of 4 cm. The standard thoracotomy is posterior- lateral thoracotomy which divided the latissimus dorsi muscle but spears the serratus anterior muscle.
OpioidsDrug
Also called Morphine
standard pain control with opioids
NSAIDDrug
Also called Perfalgan
standard pain control with NSAIDs
| Study group | Role | What they receive |
|---|---|---|
| Pectoralic block group | Experimental | After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point. Receives: Drug: Bupivacaine Hydrochloride; Device: Ultrasound; Procedure: Thoracotomy; Drug: Opioids; Drug: NSAID |
| Control group | Active comparator | Patients in this group will receive standard pain control with opioids and NSAIDs Receives: Procedure: Thoracotomy; Drug: Opioids; Drug: NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Visual Analog Score between groups
First VAS after admission in PACU
Measured: First 24 hours from the surgery
Secondary outcomes (3)
Total NSAIDs dosage (mg) in the PACU and department
While the patient is in PACU
Measured: First 24 hours from the surgery
Length of hospital stay
Measuring time of at discharge from hospital
Measured: up to 21 days
Total morphine dosage (mg) in the PACU and department
While the patient is in PACU
Measured: First 24 hours from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semionov Michael, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023982
- Sponsor's protocol ID
- SOR 34516 CTIL
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: will be decided later
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03023982
- Acronym / sponsor ID
- SOR 34516 CTIL
- Conditions
- Anesthesia, Surgery, Block, Thoracic Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- 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.
A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall
Detailed description
The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral prosthesis for pain control management.
This block is provided by injection into another myofascial plane, this time between pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block is simple in performance with a high success rate and minimal incidence of complications, especially, if used ultrasound approach that gives a good understanding of anatomy of the lateral thoracic wall.
In present clinical trial we are going to compare PECs block for pain control with traditional pain management techniques based on IV opioids and NSAIDs treatment in patient undergoing thoracic surgery in early postoperative period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectoralic block group | Experimental | Drug: Bupivacaine Hydrochloride, Device: Ultrasound, Procedure: Thoracotomy, Drug: Opioids, Drug: NSAIDAfter general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point. |
| Control group | Active comparator | Procedure: Thoracotomy, Drug: Opioids, Drug: NSAIDPatients in this group will receive standard pain control with opioids and NSAIDs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing thoracic surgery, older ≥18 years
- Patients who meet criteria of ASA I-II-III class.
Key exclusion criteria (8 listed)
- Patients who will be unconscious or mentally incompetent
- Patients refusal to participate in the study
- ASA -IV -V
- Patient with coagulopathy
- Hemodynamically unstable (systolic BP < 90, HR > 100)
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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: Marcaine40 cc 0.25% of Bupivacaine Hydrochloride injection using ultrasound approach will be administered between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib | Drug | Pectoralic block group |
| UltrasoundAlso: SonositeAll blocks will be done under ultrasound | Device | Pectoralic block group |
| ThoracotomyThe patient population will include patients that undergo either open thoracotomy or thoracoscopy for anatomic and non-anatomic lung resection. The standard thoracoscopy approach in our institute includes three holes technic. There are two incisions of 1 cm and utility incision of 4 cm. The standard thoracotomy is posterior- lateral thoracotomy which divided the latissimus dorsi muscle but spears the serratus anterior muscle. | Procedure or surgery | Control group, Pectoralic block group |
| OpioidsAlso: Morphinestandard pain control with opioids | Drug | Control group, Pectoralic block group |
| NSAIDAlso: Perfalganstandard pain control with NSAIDs | Drug | Control group, Pectoralic block group |
Primary outcome
Comparison Visual Analog Score between groups
Time frame: First 24 hours from the surgery
First VAS after admission in PACU
3 secondary outcomes
Total NSAIDs dosage (mg) in the PACU and department
Time frame: First 24 hours from the surgery
Length of hospital stay
Time frame: up to 21 days
Total morphine dosage (mg) in the PACU and department
Time frame: First 24 hours from the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: Undecided. will be decided later
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine Hydrochloride, Ultrasound and Thoracotomy in people with Anesthesia and Surgery, run by Soroka University Medical Center.
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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Comparison Visual Analog Score between groups (time frame: First 24 hours from the 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 18 Jan 2017.