SPSIPB Versus Deep SAPB for Analgesia After Breast Surgery

NCT06436599 | Completed

• 1 other identifier: 2023/0870
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Therefore, we aimed to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS)

  Evaluation of which of the two plan blocks is more effective in postoperative analgesia. Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 30. minutes, 1. hour, 4. hours, 8. hours, 12. hours and 24. hours. A lower numeric pain scale indicates a lower level of pain.

  within 24 hours postoperative

Secondary Outcomes (5)

• Comparison of tramadol(mg) consumption

  within 24 hours postoperative

• perioperative remifentanil consumption

  perioperative

• rescue anesthesia

  within 24 hours postoperative

• postoperative nausea-vomiting (PONV)

  within 24 hours postoperative

• surgeon and patient satisfaction (5-point Likert scale)

  24 hours after surgery

Study Arms (2)

Patients with serratus posterior superior intercostal plan block

ACTIVE COMPARATOR

Serratus posterior superior intercostal plane block was applied to a certain group of patients for postoperative analgesia

Other: plane block with %0.25 30 ml bupivacaine

Patients with serratus anterior plan block

ACTIVE COMPARATOR

Serratus anterior plane block was applied to a certain group of patients for postoperative analgesia

Other: plane block with %0.25 30 ml bupivacaine

Interventions

plane block with %0.25 30 ml bupivacaine OTHER

evaluation of the efficacy of two different plan blocks for postoperative analgesia

Also known as: postoperative analgesia

Patients with serratus anterior plan block; Patients with serratus posterior superior intercostal plan block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral mastectomy(modified radial mastectomy)
• ASA I-III risk group

You may not qualify if:

• Coagulopathy
• Wound and infection in the block area
• Local anaesthetic allergy
• Mental retardation
• Non-cooperative
• Pregnant patients

Sponsors & Collaborators

• Mustafa Burgac: lead

Study Sites (1)

Istanbul Professor Doctor Süleyman Yalçın City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: single blind

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 31, 2024
• Study Start: December 13, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

TU (1)