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RISS Versus SPSIP Block in Modified Radical Mastectomy

ConditionsPostoperative PainBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFerit Yetik

About this trial

This prospective randomized double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Postoperative pain scores, opioid consumption, rescue analgesic requirements, block-related complications, and quality of recovery outcomes will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-75 years

ASA physical status I-III

Scheduled for elective unilateral modified radical mastectomy with axillary dissection under general anesthesia

Provision of written informed consent

Disqualifiers

Anticoagulant therapy

Bleeding diathesis

Known allergy to local anesthetics or opioids

Infection at the block application site or previous surgery in the block area

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rhomboid Intercostal-Subserratus Plane Block

    Procedure/Surgery

    Ultrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia.

  • Serratus Posterior Superior Intercostal Plane Block

    Procedure/Surgery

    Ultrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: RISS BlockExperimental treatment 1 intervention
Group B: SPSIP BlockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Postoperative Opioid Consumption

Total opioid consumption during the first 24 hours after modified radical mastectomy.

Time frame
24 hours after surgery

Secondary outcomes

1

Postoperative Pain Scores

Postoperative pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.

Time frame
0-24 hours after surgery
2

Compartmental Pain Scores Using Numeric Rating Scale

Numeric Rating Scale (NRS) score (0-10 points) measured separately for axillary pain, anterolateral chest wall pain, and surgical drain insertion site pain. A score of 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

Time frame
0-24 hours after surgery
3

Dermatomal Sensory Block Distribution

Number of dermatomes blocked, assessed by pinprick sensory testing 30 minutes after block performance. Higher values indicate wider sensory block distribution.

Time frame
30 minutes after block performance
4

Quality of Recovery-15 Score

Quality of Recovery-15 (QoR-15) questionnaire score ranging from 0 to 150, where higher scores indicate better postoperative recovery and patient satisfaction.

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

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

Ferit Yetik

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Sponsor institution

Bursa City Hospital

Collaborator

Source ClinicalTrials.gov
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