An interventional study of Bupivacaine 0.25% (20 mL) and Bupivacaine 0.25% (30 mL) in Postoperative Pain, sponsored by Bursa City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Bursa City Hospital · Not applicable, Interventional, and Other
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 90 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Bursa City Hospital is the lead sponsor of 71 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an ultrasound-guided SPSIP block with 20 mL of 0.25% bupivacaine before general anesthesia.
Drug: Bupivacaine 0.25% (20 mL)
Participants will receive an ultrasound-guided SPSIP block with 30 mL of 0.25% bupivacaine before general anesthesia.
Drug: Bupivacaine 0.25% (30 mL)
Participants will receive an ultrasound-guided SPSIP block with 40 mL of 0.25% bupivacaine before general anesthesia.
Drug: Bupivacaine 0.25% (40 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.
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.
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.
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.
Time frame: During the first 24 hours after surgery
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.
Time frame: 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.
Time frame: At 24 hours after surgery
Plan to share: No — Individual participant data sharing is not planned.
No publications or documents are linked to this record.
Ran from Mar 2026 to primary completion in Nov 2026, 7 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 7 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Feb 2027 → Nov 2026 and completion Feb 2027 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
Bursa City Hospital