Postoperative PainSPSIP-VOLUMENCT07783386
Effect of Different Volumes of SPSIP Block in Breast Surgery
A study testing Bupivacaine 0.25% (20 mL), Bupivacaine 0.25% (30 mL) and Bupivacaine 0.25% (40 mL) in people with Postoperative Pain, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized, double-blind study will compare the effectiveness of three different volumes of serratus posterior superior intercostal plane block for postoperative pain control in patients undergoing unilateral breast surgery with axillary lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine 0.25% (20 mL), Bupivacaine 0.25% (30 mL) and Bupivacaine 0.25% (40 mL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 5 Nov 2026
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years
- American Society of Anesthesiologists physical status I-III
- Scheduled for elective unilateral breast surgery under general anesthesia
- Able to provide written informed consent
Who cannot join
- Refusal to participate
- Coagulopathy
- Known allergy to local anesthetics or a history of local anesthetic systemic toxicity
- Liver or kidney failure
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
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- Cognitive impairment or inability to understand the study procedures
- Chronic pain requiring opioid therapy
- Current antidepressant use
- Neuropathic pain
- Infection at the block injection site
- Pregnancy, suspected pregnancy, or breastfeeding
- Clinically significant frailty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Serratus Posterior Superior Intercostal Plane Block Administered With Different Volumes of 0.25% Bupivacaine for Postoperative Analgesia in Breast Surgery: A Prospective, Randomized, Double-Blind Study
This randomized, double-blind study will compare the effectiveness of three different volumes of serratus posterior superior intercostal plane block for postoperative pain control in patients undergoing unilateral breast surgery with axillary lymph node dissection. Ninety participants will be randomly assigned to receive 20 mL, 30 mL, or 40 mL of 0.25% bupivacaine.
The primary outcome is total tramadol consumption during the first 24 hours after surgery. Pain scores, time to first analgesic request, rescue analgesic use, quality of recovery, postoperative nausea and vomiting, block success, and block-related complications will also be evaluated.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine 0.25% (20 mL), Bupivacaine 0.25% (30 mL), Bupivacaine 0.25% (40 mL)
- Keywords
- Breast Surgery, Serratus Posterior Superior Intercostal Plane Block, SPSIP Block, Regional Anesthesia, Opioid Consumption, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% (20 mL)Drug
A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.
Bupivacaine 0.25% (30 mL)Drug
A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 30 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.
Bupivacaine 0.25% (40 mL)Drug
A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 40 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.
| Study group | Role | What they receive |
|---|---|---|
| 20 mL SPSIP Block Group | Experimental | Participants will receive an ultrasound-guided SPSIP block with 20 mL of 0.25% bupivacaine before general anesthesia. Receives: Drug: Bupivacaine 0.25% (20 mL) |
| 30 mL SPSIP Block Group | Experimental | Participants will receive an ultrasound-guided SPSIP block with 30 mL of 0.25% bupivacaine before general anesthesia. Receives: Drug: Bupivacaine 0.25% (30 mL) |
| 40 mL SPSIP Block Group | Experimental | Participants will receive an ultrasound-guided SPSIP block with 40 mL of 0.25% bupivacaine before general anesthesia. Receives: Drug: Bupivacaine 0.25% (40 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Tramadol Consumption
Cumulative tramadol consumption delivered through patient-controlled analgesia will be recorded in milligrams and compared among the 20 mL, 30 mL, and 40 mL SPSIP block groups. Higher values indicate greater opioid consumption.
Measured: During the first 24 hours after surgery
Secondary outcomes (2)
Postoperative Pain Intensity
Pain intensity will be assessed using the 11-point Numerical Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). Static pain will be evaluated at rest. Dynamic pain will be evaluated during 30-60 degrees of arm abduction on the operated side and during deep inspiration. Higher scores indicate greater pain intensity.
Measured: At 0, 2, 4, 8, 16, and 24 hours after surgery
Quality of Recovery-15 Score
Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start15 Mar 2026
- Primary completion5 Nov 2026
- Study completion5 Nov 2026
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Ulusoy, Emre, M.D.
- Responsible party
- Principal investigator, Mursel Ekinci, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783386
- Sponsor's protocol ID
- BSH16
- Other IDs
- 26-AKD-46
- Acronym
- SPSIP-VOLUME
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data sharing is not planned.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Serratus Posterior Superior Intercostal Plane Block Administered With Different Volumes of 0.25% Bupivacaine for Postoperative Analgesia in Breast Surgery: A Prospective, Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT07783386
- Acronym / sponsor ID
- SPSIP-VOLUME / BSH16
- Conditions
- Postoperative Pain
- Keywords
- Breast Surgery, Serratus Posterior Superior Intercostal Plane Block, SPSIP Block, Regional Anesthesia, Opioid Consumption, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Collaborators
- Ulusoy, Emre, M.D.
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 5 Nov 2026 (actual)
- Study completion
- 5 Nov 2026 (actual)
- First posted
- 24 Aug 2026 (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 randomized, double-blind study will compare the effectiveness of three different volumes of serratus posterior superior intercostal plane block for postoperative pain control in patients undergoing unilateral breast surgery with axillary lymph node dissection. Ninety participants will be randomly assigned to receive 20 mL, 30 mL, or 40 mL of 0.25% bupivacaine.
The primary outcome is total tramadol consumption during the first 24 hours after surgery. Pain scores, time to first analgesic request, rescue analgesic use, quality of recovery, postoperative nausea and vomiting, block success, and block-related complications will also be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 mL SPSIP Block Group | Experimental | Drug: Bupivacaine 0.25% (20 mL)Participants will receive an ultrasound-guided SPSIP block with 20 mL of 0.25% bupivacaine before general anesthesia. |
| 30 mL SPSIP Block Group | Experimental | Drug: Bupivacaine 0.25% (30 mL)Participants will receive an ultrasound-guided SPSIP block with 30 mL of 0.25% bupivacaine before general anesthesia. |
| 40 mL SPSIP Block Group | Experimental | Drug: Bupivacaine 0.25% (40 mL)Participants will receive an ultrasound-guided SPSIP block with 40 mL of 0.25% bupivacaine before general anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 75 years
- American Society of Anesthesiologists physical status I-III
- Scheduled for elective unilateral breast surgery under general anesthesia
- Able to provide written informed consent
Key exclusion criteria (13 listed)
- Refusal to participate
- Coagulopathy
- Known allergy to local anesthetics or a history of local anesthetic systemic toxicity
- Liver or kidney failure
- 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 |
|---|---|---|
| Bupivacaine 0.25% (20 mL)A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level. | Drug | 20 mL SPSIP Block Group |
| Bupivacaine 0.25% (30 mL)A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 30 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level. | Drug | 30 mL SPSIP Block Group |
| Bupivacaine 0.25% (40 mL)A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 40 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level. | Drug | 40 mL SPSIP Block Group |
Primary outcome
Total Postoperative Tramadol Consumption
Time frame: During the first 24 hours after surgery
Cumulative tramadol consumption delivered through patient-controlled analgesia will be recorded in milligrams and compared among the 20 mL, 30 mL, and 40 mL SPSIP block groups. Higher values indicate greater opioid consumption.
2 secondary outcomes
Postoperative Pain Intensity
Time frame: At 0, 2, 4, 8, 16, and 24 hours after surgery
Quality of Recovery-15 Score
Time frame: At 24 hours after surgery
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 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data sharing is not planned.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25% (20 mL), Bupivacaine 0.25% (30 mL) and Bupivacaine 0.25% (40 mL) in people with Postoperative Pain, run by Bursa City 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 4 inclusion and 13 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 6 Nov 2026. 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?
Total Postoperative Tramadol Consumption (time frame: During the first 24 hours after surgery). 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 6 Nov 2026.