Nerve BlockNCT03483415
Long Thoracic Nerve Blockade for Pain Treatment After Video-Assisted Thoracoscopic Surgery
A study testing Morphine Sulfate and Bupivacaine in people with Nerve Block and Video-Assisted Thoracic Surgery, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
Video-assisted thoracoscopic surgery (VATS) provides an opportunity to penetrate the thoracic cavity by video through an incision into the chest wall and facilitate surgical operation of lung pathologies.Various regional methods of anesthesia are currently being used to achieve this goal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Block, Video-Assisted Thoracic Surgery
- What is being tested?
- Morphine Sulfate and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Apr 2019
- 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
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).
Who cannot join
- Previous history of opioid use preoperatively,
- Allergy to local anesthetics,
- The presence of any systemic infection,
- Uncontrolled arterial hypertension,
- Uncontrolled diabetes mellitus.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of Analgesic Effect of Long Thoracic Nerve Blockade After VATS (Video-Assisted Thoracoscopic Surgery) Operation
Video-assisted thoracoscopic surgery (VATS) provides an opportunity to penetrate the thoracic cavity by video through an incision into the chest wall and facilitate surgical operation of lung pathologies.Various regional methods of anesthesia are currently being used to achieve this goal.
The aim of the study was to assess the effectiveness of Long thoracic nerve bloc on postoperative VATS analgesia.
- Conditions
- Nerve Block, Video-Assisted Thoracic Surgery
- Being tested
- Morphine Sulfate, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called Morphine
Intravenous morphine infusion with PCA: Solution was concentration of 0.5 mg/mL. Loading dose of 1 mg, 0.5 mg of bolus dose and 20 min of locking time.
BupivacaineDrug
Ultrasound guided Long thoracic nerve blockage with 5 ml % 0.25 bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Grup L | Experimental | IV patient-controlled analgesia (PCA) morphine
+ Ultrasound guided Long thoracic nerve blockage with 5 ml % 0.25 bupivacaine Receives: Drug: Morphine Sulfate; Drug: Bupivacaine |
| Group P | Active comparator | IV patient-controlled analgesia (PCA) morphine Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
morphine consumption
Measured: Postoperative 24 hours
Secondary outcomes (5)
Visual Analog Scale
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)
Measured: Postoperative 24 hours
side effect (Hypotension)
side effect Hypotension
Measured: Postoperative 24 hours
additional analgesic use
additional analgesic use
Measured: Postoperative 24 hours
side effect (Nausea and vomiting)
Nausea and vomiting scale
- Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present, 2. Mild nausea is present. 3. Severe nausea is present. 4. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.
Measured: Postoperative 24 hours
side effect (Ramsay Sedation Scale (RSS)
Ramsay Sedation Scale (Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated, awake; 3. Sedatized, response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and 6. Sleepy, no response to auditory stimulus or glabella tap)
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 posted30 Mar 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, single-blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, M.D, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483415
- Sponsor's protocol ID
- 2011-KAEK-25 2018/02-01
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 30 Mar 2018
- 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 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Analgesic Effect of Long Thoracic Nerve Blockade After VATS (Video-Assisted Thoracoscopic Surgery) Operation
- ClinicalTrials.gov ID
- NCT03483415
- Acronym / sponsor ID
- 2011-KAEK-25 2018/02-01
- Conditions
- Nerve Block, Video-Assisted Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 30 Mar 2018 (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.
Video-assisted thoracoscopic surgery (VATS) provides an opportunity to penetrate the thoracic cavity by video through an incision into the chest wall and facilitate surgical operation of lung pathologies.Various regional methods of anesthesia are currently being used to achieve this goal.
The aim of the study was to assess the effectiveness of Long thoracic nerve bloc on postoperative VATS analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, single-blind
| Arm | Type | Receives |
|---|---|---|
| Grup L | Experimental | Drug: Morphine Sulfate, Drug: BupivacaineIV patient-controlled analgesia (PCA) morphine + Ultrasound guided Long thoracic nerve blockage with 5 ml % 0.25 bupivacaine |
| Group P | Active comparator | Drug: Morphine SulfateIV patient-controlled analgesia (PCA) morphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).
Key exclusion criteria (5 listed)
- Previous history of opioid use preoperatively,
- Allergy to local anesthetics,
- The presence of any systemic infection,
- Uncontrolled arterial hypertension,
- Uncontrolled diabetes mellitus.
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 |
|---|---|---|
| Morphine SulfateAlso: MorphineIntravenous morphine infusion with PCA: Solution was concentration of 0.5 mg/mL. Loading dose of 1 mg, 0.5 mg of bolus dose and 20 min of locking time. | Drug | Group P, Grup L |
| BupivacaineUltrasound guided Long thoracic nerve blockage with 5 ml % 0.25 bupivacaine | Drug | Grup L |
Primary outcome
morphine consumption
Time frame: Postoperative 24 hours
morphine consumption
5 secondary outcomes
Visual Analog Scale
Time frame: Postoperative 24 hours
side effect (Hypotension)
Time frame: Postoperative 24 hours
additional analgesic use
Time frame: Postoperative 24 hours
side effect (Nausea and vomiting)
Time frame: Postoperative 24 hours
side effect (Ramsay Sedation Scale (RSS)
Time frame: Postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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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.
Korgün Ökmen, M.D principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Morphine Sulfate and Bupivacaine in people with Nerve Block and Video-Assisted Thoracic Surgery, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Mar 2018. 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.
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 korgün Ökmen, M.D (+902242955000, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: Postoperative 24 hours). 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 30 Mar 2018.