Post Operative PainNCT05901116
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
A study testing Serratus posterior superior intercostal plane block (SPSIPB) in people with Post Operative Pain, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing reduction mammoplasty. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Serratus posterior superior intercostal plane block (SPSIPB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2023to 1 Jun 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients older than 18 years of age who underwent reduction mammoplasty under general anesthesia and are American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Who cannot join
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing reduction mammoplasty.
Read the detailed description
Ten patients had serratus posterior superior intercostal plane block (SPSIPB) as the intervention. Patients had SPSIPB with 0.25% bupivacaine (total volume of 30 ml) before the surgery in operating room. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated by using patient-controlled analgesia (PCA) device. Patient satisfaction was assessed by using quality of recovery-15 (QoR15) scale. Paracetamol was planned as resque analgesic drug (maximum dose: 3 gr/day).
- Conditions
- Post Operative Pain
- Being tested
- Serratus posterior superior intercostal plane block (SPSIPB)
- Keywords
- serratus posterior superior intercostal plane block, postoperative pain, reduction mammoplasty, regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane block (SPSIPB)Other
Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle.
| Study group | Role | What they receive |
|---|---|---|
| SPSIPB | Other | SPSIPB is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. Tramadol (intravenous analgesic drug) at a concentration of 4 mg per 1 ml was administered with patient-controlled analgesia (PCA) device (max dose: 400 mg /day) Receives: Other: Serratus posterior superior intercostal plane block (SPSIPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS) scores
Numerical rating scale was used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Measured: Postoperative 24 hours
Total Tramadol consumption
Postoperative analgesic (tramadol) need was measured by using patient-controlled analgesia (PCA) device.
Measured: Postoperative 24 hours
Secondary outcomes (2)
Resque analgesic need
Total paracetamol need was recorded as "milligram" in unit despite of tramadol administration.
Measured: Postoperative 24 hours
Quality of Recovery scores
Quality of recovery-15 (QoR15) scale was used for the assessment of patients satisfaction. The scores of QoR15 changes between 0 to 150 points. 0 point means "there is no satisfaction." Higher scores mean indicating a good quality of recovery and better outcome.
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 posted13 Jun 2023
- Study start18 May 2023
- Primary completion30 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- Oğuz Gündoğdu, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901116
- Sponsor's protocol ID
- SPSIPB on mammoplasty
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
PubMed 36883093
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
- ClinicalTrials.gov ID
- NCT05901116
- Acronym / sponsor ID
- SPSIPB on mammoplasty
- Conditions
- Post Operative Pain
- Keywords
- serratus posterior superior intercostal plane block, postoperative pain, reduction mammoplasty, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 Jun 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.
The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing reduction mammoplasty.
Detailed description
Ten patients had serratus posterior superior intercostal plane block (SPSIPB) as the intervention. Patients had SPSIPB with 0.25% bupivacaine (total volume of 30 ml) before the surgery in operating room. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated by using patient-controlled analgesia (PCA) device. Patient satisfaction was assessed by using quality of recovery-15 (QoR15) scale. Paracetamol was planned as resque analgesic drug (maximum dose: 3 gr/day).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPSIPB | Other | Other: Serratus posterior superior intercostal plane block (SPSIPB)SPSIPB is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. Tramadol (intravenous analgesic drug) at a concentration of 4 mg per 1 ml was administered with patient-controlled analgesia (PCA) device (max dose: 400 mg /day) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients older than 18 years of age who underwent reduction mammoplasty under general anesthesia and are American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Key exclusion criteria (7 listed)
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
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 |
|---|---|---|
| Serratus posterior superior intercostal plane block (SPSIPB)Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. | Other | SPSIPB |
Primary outcome
Numerical rating scale (NRS) scores
Time frame: Postoperative 24 hours
Numerical rating scale was used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Total Tramadol consumption
Time frame: Postoperative 24 hours
Postoperative analgesic (tramadol) need was measured by using patient-controlled analgesia (PCA) device.
2 secondary outcomes
Resque analgesic need
Time frame: Postoperative 24 hours
Quality of Recovery scores
Time frame: Postoperative 24 hours
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 13 Jun 2023.
- Background: PubMed 36883093Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- 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.
Oğuz Gündoğdu principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus posterior superior intercostal plane block (SPSIPB) in people with Post Operative Pain, run by Cumhuriyet 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 1 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 13 Jun 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. 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?
Numerical rating scale (NRS) scores (time frame: Postoperative 24 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?
On the ClinicalTrials.gov record for NCT05901116, which also lists 1 linked publication.
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 13 Jun 2023.