Postoperative PainNCT06381765
Serratus Plane Block and Pectointercostal Block
A study testing ultrasound guided Serratus plane bock and pectointercostal block and ultrasound guided Serratus plane bock in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ultrasound guided Serratus plane bock and pectointercostal block and ultrasound guided Serratus plane bock
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 2 Sep 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients
- Female
- who will undergoing Breast reduction surgery
Who cannot join
- ASA III and over patients
- who reject to join the study
- male gender
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Deep Serratus Plane Block with Deep Serratus Plane Block+Pectointercostal Plane Block
ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours.
Read the detailed description
ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. General anesthesia with sevoflurane and remifentanil will perform to the all patients. Patients will divide into 2 groups. Serratus plane block for group I and serratus plane block+pectointercostal block for Group II will perform bilaterally. Ultrasound guided deep serratus plane block will perform with 0,25% bupivacaine 20 ml at the midaxillary 5. rib, for Group I. At Group II, ultrasound guided deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally. Patient controlled analgesia will perform with Morphine ( 1 mg bolus+ 10 min lockout+4 hours limit 10 mg) at postoperative period. Patients will evaluate with visual analogue scale (VAS) for postoperative pain scores till the first 24.th hours. Postoperative pain scores (VAS), morphine consumption and complications will record till the 24.th hours.
- Conditions
- Postoperative Pain
- Being tested
- ultrasound guided Serratus plane bock and pectointercostal block, ultrasound guided Serratus plane bock
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided Serratus plane bock and pectointercostal blockProcedure or surgery
ultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib and pectointercostal plane block (0,25% bupivacaine 15 ml) will perform at 4-5.th intercostal space. Both 2 blocks will perform bilaterally
ultrasound guided Serratus plane bockProcedure or surgery
ultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib to the all patients
| Study group | Role | What they receive |
|---|---|---|
| Serratus plane block | Active comparator | Deep serratus plane block will perform with 20 ml 0,25 %bupivacaine at the midaxillary 5. rib, bilaterally Receives: Procedure: ultrasound guided Serratus plane bock |
| Serratus plane block+pectointercostal plane block | Active comparator | deep serratus plane block (20 ml 0,25 %bupivacaine) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . Receives: Procedure: ultrasound guided Serratus plane bock and pectointercostal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption
Patient controlled analgesia with morphine will perform to the all patients and morphine consumption will calculate and record till the end of 24.th hours.
Measured: All the patients will follow till the postoperative 24.th hours and totally morphine consumption will record postoperative 24.th hours.
postoperative visual analog scale scores
All the patients will evaluate with visual analog scale scores (VAS) at the first postoperative 24.th hours period. VAS scores will define between 0-10 scores. 0 score means lowest pain score and 10 means the worst pain score.
Measured: VAS scores will record at the first postoperative 24.th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start10 May 2024
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
- Investigators
- Ebru Biricik, Principal investigator, çukurova university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381765
- Sponsor's protocol ID
- Serratus-Pectointercostal
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deep Serratus Plane Block with Deep Serratus Plane Block+Pectointercostal Plane Block
- ClinicalTrials.gov ID
- NCT06381765
- Acronym / sponsor ID
- Serratus-Pectointercostal
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 24 Apr 2024 (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.
ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours.
Detailed description
ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. General anesthesia with sevoflurane and remifentanil will perform to the all patients. Patients will divide into 2 groups. Serratus plane block for group I and serratus plane block+pectointercostal block for Group II will perform bilaterally. Ultrasound guided deep serratus plane block will perform with 0,25% bupivacaine 20 ml at the midaxillary 5. rib, for Group I. At Group II, ultrasound guided deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally. Patient controlled analgesia will perform with Morphine ( 1 mg bolus+ 10 min lockout+4 hours limit 10 mg) at postoperative period. Patients will evaluate with visual analogue scale (VAS) for postoperative pain scores till the first 24.th hours. Postoperative pain scores (VAS), morphine consumption and complications will record till the 24.th hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus plane block | Active comparator | Procedure: ultrasound guided Serratus plane bockDeep serratus plane block will perform with 20 ml 0,25 %bupivacaine at the midaxillary 5. rib, bilaterally |
| Serratus plane block+pectointercostal plane block | Active comparator | Procedure: ultrasound guided Serratus plane bock and pectointercostal blockdeep serratus plane block (20 ml 0,25 %bupivacaine) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II patients
- Female
- who will undergoing Breast reduction surgery
Key exclusion criteria (3 listed)
- ASA III and over patients
- who reject to join the study
- male gender
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 |
|---|---|---|
| ultrasound guided Serratus plane bock and pectointercostal blockultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib and pectointercostal plane block (0,25% bupivacaine 15 ml) will perform at 4-5.th intercostal space. Both 2 blocks will perform bilaterally | Procedure or surgery | Serratus plane block+pectointercostal plane block |
| ultrasound guided Serratus plane bockultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib to the all patients | Procedure or surgery | Serratus plane block |
Primary outcome
postoperative morphine consumption
Time frame: All the patients will follow till the postoperative 24.th hours and totally morphine consumption will record postoperative 24.th hours.
Patient controlled analgesia with morphine will perform to the all patients and morphine consumption will calculate and record till the end of 24.th hours.
postoperative visual analog scale scores
Time frame: VAS scores will record at the first postoperative 24.th hours
All the patients will evaluate with visual analog scale scores (VAS) at the first postoperative 24.th hours period. VAS scores will define between 0-10 scores. 0 score means lowest pain score and 10 means the worst pain score.
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 19 Sep 2024.
- 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.
Ebru Biricik principal investigator
çukurova university faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided Serratus plane bock and pectointercostal block and ultrasound guided Serratus plane bock in people with Postoperative Pain, run by Cukurova 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 3 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 19 Sep 2024. 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 morphine consumption (time frame: All the patients will follow till the postoperative 24.th hours and totally morphine consumption will record postoperative 24.th hours.). 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 19 Sep 2024.