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Recruiting NCT07659990

RISS Versus SPSIP Block in Modified Radical Mastectomy

No phase Interventional Postoperative Pain Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rhomboid Intercostal-Subserratus Plane Block, Serratus Posterior Superior Intercostal Plane Block.
Who it may be relevant to
Registry conditions: Postoperative Pain, Breast Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Rhomboid Intercostal-Subserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia and Dermatomal Spread After Modified Radical Mastectomy: A Randomized Double-Blind Trial

Overview

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.

Detailed description

Breast cancer surgery is frequently associated with moderate to severe postoperative pain, which may negatively affect recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia strategies for breast surgery.

The rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block are recently described regional anesthesia techniques that may provide effective postoperative analgesia by blocking the lateral and posterior branches of the thoracic spinal nerves. However, comparative clinical evidence regarding their analgesic efficacy and dermatomal coverage in modified radical mastectomy remains limited.

This prospective randomized double-blind controlled trial will compare RISS block and SPSIP block in adult patients undergoing modified radical mastectomy under general anesthesia. Participants will be randomly allocated to receive either RISS block or SPSIP block before surgery. The primary objective is to compare postoperative opioid consumption. Secondary outcomes include postoperative pain scores, dermatomal sensory spread, time to first rescue analgesia, quality of recovery, opioid-related adverse events, and block-related complications.

Interventions

  • Procedure Rhomboid Intercostal-Subserratus Plane Block
    Ultrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia.
  • Procedure Serratus Posterior Superior Intercostal Plane Block
    Ultrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia.

Primary outcome measures

  • Total Postoperative Opioid Consumption [Time frame: 24 hours after surgery]
Secondary outcome measures (6)
  • Postoperative Pain Scores [Time frame: 0-24 hours after surgery]
  • Compartmental Pain Scores Using Numeric Rating Scale [Time frame: 0-24 hours after surgery]
  • Dermatomal Sensory Block Distribution [Time frame: 30 minutes after block performance]
  • Quality of Recovery-15 Score [Time frame: 24 hours after surgery]
  • Intraoperative Remifentanil Consumption [Time frame: During surgery]
  • Block- and Opioid-Related Complications [Time frame: 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Anticoagulant therapy
  • Bleeding diathesis
  • Known allergy to local anesthetics or opioids
  • Infection at the block application site or previous surgery in the block area
  • Cognitive impairment preventing NRS assessment
  • Pregnancy or lactation
  • Chronic opioid use
  • Severe hepatic or renal failure
  • Refusal to participate in the study
  • Technical inability to perform the block or failed block

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bursa City Hospital — Bursa

Identifiers

NCT: NCT07659990 · MRM-2025-KAEK47 · 2025-KAEK-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗