Thoracic Paravertebral BlockNCT04855994
Comparison of Thoracic Paravertebral Block and Pectoral Nerve Block
A study testing paravertebral block and pectoral block in people with Thoracic Paravertebral Block and Video-assisted Thoracoscopic Surgery, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Paravertebral Block, Video-assisted Thoracoscopic Surgery, Postoperative Analgesia
- What is being tested?
- paravertebral block and pectoral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2017to 28 Aug 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18-65
- Patients who will undergo VATS
- ASA I-II-III patients
Who cannot join
- Patients with ASA IV
- Clinically diagnosis of spinal or chest wall deformity or pathology
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
- Clinically diagnosis of psychiatric disease
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: Comparison of the Results of Ultrasound-Guided Thoracic Paravertebral Block and Modified Pectoral Nerve Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery; A Prospective, Randomized Controlled Study
This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS.
Read the detailed description
52 patients (ASA I-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and TPVB groups) Thoracic paravertebral block was administered from two consecutive levels for TPVB group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, visual analog scale values during at rest and coughing, time of the first analgesic request, and additional analgesic consumption were recorded.
- Conditions
- Thoracic Paravertebral Block, Video-assisted Thoracoscopic Surgery, Postoperative Analgesia
- Being tested
- paravertebral block, pectoral block
- Keywords
- Thoracic paravertebral block,, pectoralis block,, Video-assisted thoracoscopic surgery,, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockProcedure or surgery
The investigators performed Paravertebral block to that patient group for postoperative analgesia
pectoral blockProcedure or surgery
The investigators performed pectoral block to that patient group for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| paravertebral group | Active comparator | The investigators performed Paravertebral block to that patient group for postoperative analgesia Receives: Procedure: paravertebral block |
| pectoral group | Active comparator | The investigators performed pectoral block to that patient group for postoperative analgesia Receives: Procedure: pectoral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24-hours total morphine consumption of patients
This will be measured only one time by pca device at the 24th hour after surgery.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Visual Analog Scale values of patients
Visual Analog Scale (VAS, 0-10; 0= no pain and 10= very severe unbearable pain) at 0-1-2-4-8-12 and 24th hours
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start28 Jun 2017
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Paravertebral 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Gokhan Sertcakacilar, MD, Study director, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855994
- Sponsor's protocol ID
- 2017-140
- Status last verified
- Jul 2021
- First submitted
- 9 Apr 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Results of Ultrasound-Guided Thoracic Paravertebral Block and Modified Pectoral Nerve Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery; A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04855994
- Acronym / sponsor ID
- 2017-140
- Conditions
- Thoracic Paravertebral Block, Video-assisted Thoracoscopic Surgery, Postoperative Analgesia
- Keywords
- Thoracic paravertebral block,, pectoralis block,, Video-assisted thoracoscopic surgery,, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 22 Apr 2021 (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 efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS.
Detailed description
52 patients (ASA I-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and TPVB groups) Thoracic paravertebral block was administered from two consecutive levels for TPVB group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, visual analog scale values during at rest and coughing, time of the first analgesic request, and additional analgesic consumption were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paravertebral group | Active comparator | Procedure: paravertebral blockThe investigators performed Paravertebral block to that patient group for postoperative analgesia |
| pectoral group | Active comparator | Procedure: pectoral blockThe investigators performed pectoral block to that patient group for postoperative analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages of 18-65
- Patients who will undergo VATS
- ASA I-II-III patients
Key exclusion criteria (7 listed)
- Patients with ASA IV
- Clinically diagnosis of spinal or chest wall deformity or pathology
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
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 |
|---|---|---|
| paravertebral blockThe investigators performed Paravertebral block to that patient group for postoperative analgesia | Procedure or surgery | paravertebral group |
| pectoral blockThe investigators performed pectoral block to that patient group for postoperative analgesia | Procedure or surgery | pectoral group |
Primary outcome
Postoperative 24-hours total morphine consumption of patients
Time frame: 24 hours postoperatively
This will be measured only one time by pca device at the 24th hour after surgery.
1 secondary outcome
Visual Analog Scale values of patients
Time frame: 24 hours postoperatively
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 9 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Gokhan Sertcakacilar, MD study director
Bakirkoy Dr. Sadi Konuk Research and Training 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 paravertebral block and pectoral block in people with Thoracic Paravertebral Block and Video-assisted Thoracoscopic Surgery, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 7 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 9 Jul 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 Turkey (Türkiye). 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?
Postoperative 24-hours total morphine consumption of patients (time frame: 24 hours postoperatively). 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 9 Jul 2021.