AnalgesiaNCT06089512
Comparison of Midpoint Transverse Process to Pleura Block and Thoracic Paravertebral Block
A study testing paravertebral block group and Mid point transverse process block group in people with Analgesia and Post Operative Pain, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
In this study, hypothesis is that the MTPB (mid point transverse process block), which is easier and has fewer complications in patients aged 18-80 undergoing video-assisted thoracic surgery (VATS), provides analgesia as effective as PVB. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Post Operative Pain
- What is being tested?
- paravertebral block group and Mid point transverse process block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 20 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 80 years of age
- American Society of Anesthesiologists I-II physical status of and
- Body mass index of 19 to 28 kg/m2
Who cannot join
- Patients who had coagulopathy
- Previous thoracic surgery
- Emotional instability
- Significant encephalopathy
- Preexisting motor or sensory deficit
- Other contraindications to local anaesthesia, such as allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Midpoint Transverse Process to Pleura Block and Thoracic Paravertebral Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery (VATS)"
In this study, hypothesis is that the MTPB (mid point transverse process block), which is easier and has fewer complications in patients aged 18-80 undergoing video-assisted thoracic surgery (VATS), provides analgesia as effective as PVB.
Read the detailed description
Patients between the ages of 18 to 80, scheduled for Video-Assisted Thoracoscopic Surgery (VATS) and classified under the American Society of Anesthesiologists (ASA) class I and II, will be included in the study. Patients with known or suspected local anesthetic allergies, coagulopathy, site injection infections, a history of thoracic surgery, severe neurological or psychiatric disorders, severe cardiovascular diseases, liver failure, kidney failure (glomerular filtration rate <15 ml/min/1.73 m2), and chronic opioid use will be excluded from the study.
Demographic information of the patients (name, protocol number, weight, height, age, body mass index, comorbidities, ASA score) will be recorded. Subsequently, after necessary information is provided, and written and verbal consent is obtained, patients will be randomized into three groups:
Group MTPB: After the induction of general anesthesia and intubation in the operating room, the patient will be placed in the lateral decubitus position. Using ultrasound guidance, a linear probe will be used to perform a MTPB at the midpoint of the superior costotransverse ligament at the level of the 5th intercostal space. A 0.5 ml/kg solution of 0.25% bupivacaine will be administered in-plane.
Group PVB: After the induction of general anesthesia and intubation in the operating room, the patient will be placed in the lateral decubitus position. Using ultrasound guidance, a linear probe will be used to perform a paravertebral block (PVB) at the level of the 5th intercostal space. A 0.5 ml/kg solution of 0.25% bupivacaine will be administered in-plane.
Group P: No peripheral block will be performed in this group.
All patients' hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded at 30-minute intervals during the intraoperative period, as well as the amount of opioids used during the surgery. Fifteen minutes before awakening, an intravenous patient-controlled analgesia (PCA) device will be connected, delivering a bolus dose of 2 ml of 1 mg/ml morphine solution with a lockout time of 15 minutes.
During the postoperative period, visual analog pain scores (VAS) will be assessed at 0, 30 minutes, 1, 2, 4, 8, 12, 24, 36, and 48 hours, both at rest and during coughing. Additionally, the time to first analgesic requirement, total analgesic consumption, need for rescue analgesia (contramal 100 mg/2 ml), amount required, possible opioid side effects (nausea, vomiting, respiratory depression, sedation), and time to awakening will be recorded.
The time to first mobilization, postoperative complications, time to discharge, and satisfaction of both patients and the surgical team will be recorded using a 5-point Likert scale.
- Conditions
- Analgesia, Post Operative Pain
- Being tested
- paravertebral block group, Mid point transverse process block group, Control group
- Keywords
- thoracic, analgesia, post operative pain, surgery-complication
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral block groupProcedure or surgery
Paravertebral block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.
Mid point transverse process block groupProcedure or surgery
Mid point transverse process block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.
Control groupProcedure or surgery
Only general anesthesia was applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | group receiving general anesthesia only Receives: Procedure: Control group |
| paravertebral block group | Active comparator | received single-shot paravertebral block after induction of anesthesia. Receives: Procedure: paravertebral block group |
| mid transverse process block group | Active comparator | received a mid-transverse process -to- pleura block after induction of anesthesia. Receives: Procedure: Mid point transverse process block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative analgesic effects of peripheral blocks
Investigators will compare the intraoperative analgesic effects by opioid consumption in intraoperative phase.
Measured: First day
Postoperative analgesic effects of peripheral blocks
Visual Analogue Scale (VAS) will be used for postoperative analgesic effects.
Measured: First day
Secondary outcomes (2)
opioid consumed through PCA (patient controlled analgesia)
PCA was used for pain control. An iv solution was prepared to all participants with 100 mg morphine hydrochloride at a concentration of 1 mg/ml in 90 ml saline and the bolus dose was set as 2 ml and the locked time as 15 min. From the recovery unit, a bolus dose of morphine was administered with the PCA device if VAS≥4 by questioning or upon the request of the participants. Participants who had VAS≥4 despite PCA were administered 50 mg dexketoprofen iv as rescue analgesic and 50 mg tramadol intramuscularly as the second rescue analgesic if VAS≥4 continued.
Measured: first day
Side effects
The necessity for supplementary analgesics, any complications associated with the puncture procedure such as infection, hematoma, and pneumothorax (confirmed via direct thoracoscopic visualization), the incidence of postoperative nausea and vomiting.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Nov 2022
- Primary completion15 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansabuncu, Uludag University
- Investigators
- seda cansabuncu, Principal investigator, BURSA ULUDAG UNIVERSITY HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089512
- Sponsor's protocol ID
- 2022-17/22
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we plan share ,study Protocol, statistical Analysis Plan (SAP), informed Consent Form (ICF)
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Midpoint Transverse Process to Pleura Block and Thoracic Paravertebral Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery (VATS)"
- ClinicalTrials.gov ID
- NCT06089512
- Acronym / sponsor ID
- 2022-17/22
- Conditions
- Analgesia, Post Operative Pain
- Keywords
- thoracic, analgesia, post operative pain, surgery-complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 18 Oct 2023 (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.
In this study, hypothesis is that the MTPB (mid point transverse process block), which is easier and has fewer complications in patients aged 18-80 undergoing video-assisted thoracic surgery (VATS), provides analgesia as effective as PVB.
Detailed description
Patients between the ages of 18 to 80, scheduled for Video-Assisted Thoracoscopic Surgery (VATS) and classified under the American Society of Anesthesiologists (ASA) class I and II, will be included in the study. Patients with known or suspected local anesthetic allergies, coagulopathy, site injection infections, a history of thoracic surgery, severe neurological or psychiatric disorders, severe cardiovascular diseases, liver failure, kidney failure (glomerular filtration rate <15 ml/min/1.73 m2), and chronic opioid use will be excluded from the study.
Demographic information of the patients (name, protocol number, weight, height, age, body mass index, comorbidities, ASA score) will be recorded. Subsequently, after necessary information is provided, and written and verbal consent is obtained, patients will be randomized into three groups:
Group MTPB: After the induction of general anesthesia and intubation in the operating room, the patient will be placed in the lateral decubitus position. Using ultrasound guidance, a linear probe will be used to perform a MTPB at the midpoint of the superior costotransverse ligament at the level of the 5th intercostal space. A 0.5 ml/kg solution of 0.25% bupivacaine will be administered in-plane.
Group PVB: After the induction of general anesthesia and intubation in the operating room, the patient will be placed in the lateral decubitus position. Using ultrasound guidance, a linear probe will be used to perform a paravertebral block (PVB) at the level of the 5th intercostal space. A 0.5 ml/kg solution of 0.25% bupivacaine will be administered in-plane.
Group P: No peripheral block will be performed in this group.
All patients' hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded at 30-minute intervals during the intraoperative period, as well as the amount of opioids used during the surgery. Fifteen minutes before awakening, an intravenous patient-controlled analgesia (PCA) device will be connected, delivering a bolus dose of 2 ml of 1 mg/ml morphine solution with a lockout time of 15 minutes.
During the postoperative period, visual analog pain scores (VAS) will be assessed at 0, 30 minutes, 1, 2, 4, 8, 12, 24, 36, and 48 hours, both at rest and during coughing. Additionally, the time to first analgesic requirement, total analgesic consumption, need for rescue analgesia (contramal 100 mg/2 ml), amount required, possible opioid side effects (nausea, vomiting, respiratory depression, sedation), and time to awakening will be recorded.
The time to first mobilization, postoperative complications, time to discharge, and satisfaction of both patients and the surgical team will be recorded using a 5-point Likert scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: Control groupgroup receiving general anesthesia only |
| paravertebral block group | Active comparator | Procedure: paravertebral block groupreceived single-shot paravertebral block after induction of anesthesia. |
| mid transverse process block group | Active comparator | Procedure: Mid point transverse process block groupreceived a mid-transverse process -to- pleura block after induction of anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 and 80 years of age
- American Society of Anesthesiologists I-II physical status of and
- Body mass index of 19 to 28 kg/m2
Key exclusion criteria (6 listed)
- Patients who had coagulopathy
- Previous thoracic surgery
- Emotional instability
- Significant encephalopathy
- Preexisting motor or sensory deficit
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 block groupParavertebral block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated. | Procedure or surgery | paravertebral block group |
| Mid point transverse process block groupMid point transverse process block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated. | Procedure or surgery | mid transverse process block group |
| Control groupOnly general anesthesia was applied to the patients. | Procedure or surgery | Control group |
Primary outcome
Intraoperative analgesic effects of peripheral blocks
Time frame: First day
Investigators will compare the intraoperative analgesic effects by opioid consumption in intraoperative phase.
Postoperative analgesic effects of peripheral blocks
Time frame: First day
Visual Analogue Scale (VAS) will be used for postoperative analgesic effects.
2 secondary outcomes
opioid consumed through PCA (patient controlled analgesia)
Time frame: first day
Side effects
Time frame: First day
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 18 Oct 2023.
- Individual participant dataSharing planned: No. we plan share ,study Protocol, statistical Analysis Plan (SAP), informed Consent Form (ICF)
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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.
seda cansabuncu principal investigator
BURSA ULUDAG UNIVERSITY 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 group and Mid point transverse process block group in people with Analgesia and Post Operative Pain, run by Uludag University 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 6 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 18 Oct 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 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. Some participants in this study may receive a placebo. 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?
Intraoperative analgesic effects of peripheral blocks (time frame: First day). 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 18 Oct 2023.