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NCT Number: NCT07659990

RISS Versus SPSIP Block in Modified Radical Mastectomy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bursa City Hospital

Bursa, Nilüfer, 16100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yusuf Alan, MD

CONTACT

[email protected]

05396210977

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhomboid Intercostal-Subserratus Plane Block

Procedure

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

Serratus Posterior Superior Intercostal Plane Block

Procedure

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

Primary outcomes

  1. Total Postoperative Opioid Consumption

    Time frame: 24 hours after surgery

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

Secondary outcomes

  1. Postoperative Pain Scores

    Time frame: 0-24 hours after surgery

    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.

  2. Compartmental Pain Scores Using Numeric Rating Scale

    Time frame: 0-24 hours after surgery

    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.

  3. Dermatomal Sensory Block Distribution

    Time frame: 30 minutes after block performance

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

  4. Quality of Recovery-15 Score

    Time frame: 24 hours after surgery

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

  5. Intraoperative Remifentanil Consumption

    Time frame: During surgery

    Total intraoperative remifentanil consumption will be recorded and compared between groups.

  6. Block- and Opioid-Related Complications

    Time frame: 24 hours after surgery

    Complications related to block performance and opioid use will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Yusuf Alan, MD

CONTACT

[email protected]

+905396210977

Sponsors and collaborators

Lead sponsor

Ferit Yetik

Other Gov

Collaborators

  • Bursa City Hospital

Registry information

Official study 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

Acronym: RSMRM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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