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Effect of Different Volumes of SPSIP Block in Breast Surgery

ConditionPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorBursa City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal to participate

Coagulopathy

Known allergy to local anesthetics or a history of local anesthetic systemic toxicity

Liver or kidney failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: 20 mL SPSIP Block GroupExperimental treatment 1 intervention
Group B: 30 mL SPSIP Block GroupExperimental treatment 1 intervention
Group C: 40 mL SPSIP Block GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bursa City Hospital

Lead sponsor

Ulusoy, Emre, M.D.

Collaborator

Source ClinicalTrials.gov
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