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Clinical Trials/NCT07229092
NCT07229092Active, not recruitingNot Applicable

Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Reduction Surgery: A Randomized Clinical Study

Konul Karaja1 site in 1 country90 target enrollmentStarted: February 2, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Total Tramadol Consumption Within the First 24 Hours After Surgery

Study Overview

Brief Summary

This prospective, randomized clinical study aims to compare the analgesic efficacy of serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) for postoperative analgesia in patients undergoing elective bilateral breast reduction surgery under general anesthesia. All patients will receive standardized general anesthesia. Before induction of anesthesia, while patients are awake, Group SPB will receive an ultrasound-guided serratus anterior plane block and Group RIPB will receive an ultrasound-guided rhomboid intercostal plane block. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (PCA) with opioids. Primary outcomes include postoperative pain scores and opioid consumption at 1, 6, 12, and 24 hours. Secondary outcomes include time to first analgesic demand, patient satisfaction, and block-related complications.

Detailed Description

Postoperative pain management in breast reduction surgery is challenging due to wide tissue dissection and thoracic wall involvement. Serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) are regional anesthesia techniques that provide analgesia by blocking the lateral cutaneous branches of the intercostal nerves.

This randomized controlled trial will compare the analgesic efficacy of SPB and RIPB in female patients aged 18-65 undergoing elective bilateral breast reduction surgery under general anesthesia.

Before induction of general anesthesia, while patients are awake, ultrasound-guided SPB or RIPB will be performed according to group allocation. After block performance, general anesthesia will be induced using a standardized protocol. Postoperative pain management will be provided with intravenous patient-controlled analgesia (PCA) with opioids.

Primary outcomes include postoperative pain scores (NRS) and opioid consumption. Secondary outcomes include duration of analgesia, time to first analgesic request, patient satisfaction, and block-related complications. The hypothesis is that both blocks will reduce postoperative pain and opioid consumption, but the duration and quality of analgesia may differ between SPB and RIPB.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None (Participant, Outcomes Assessor)

Masking Description

The patients and the outcome assessor who recorded postoperative pain scores were blinded to the type of block performed

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Female patients aged 18-65 years
  • •American Society of Anesthesiologists (ASA) physical status I-II
  • •Scheduled for elective bilateral breast reduction surgery under general anesthesia
  • •Willing and able to provide written informed consent

Exclusion Criteria

  • •Allergy or contraindication to local anesthetics (bupivacaine)
  • •Coagulopathy or anticoagulant medication use
  • •Infection at or near the injection site
  • •History of chronic opioid use or psychiatric/neurological disorders affecting pain perception
  • •Body mass index (BMI) > 35 kg/m²
  • •Refusal to participate in the study

Arms & Interventions

Control Group (No Block)

Other

Patients in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol

Intervention: No Regional Block (Control) (Other)

Serratus Plane Block

Experimental

"Patients in this group will receive an ultrasound-guided serratus anterior plane block (SAPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered to the right side and 15 mL to the left side. Each side will receive a single injection point along the midaxillary line to provide adequate spread within the serratus plane.

Intervention: Serratus Anterior Plane Block (SAPB) (Procedure)

Rhomboid Intercostal Plane Block

Active Comparator

"Patients in this group will receive an ultrasound-guided rhomboid intercostal plane block (RIPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered on the right and 15 mL on the left. Each side will receive a single injection point beneath the medial border of the scapula at the level of the intercostal plane to ensure adequate spread between the rhomboid major muscle and intercostal muscles."

Intervention: Rhomboid Intercostal Plane Block (RIPB) (Procedure)

Outcomes

Primary Outcomes

Total Tramadol Consumption Within the First 24 Hours After Surgery

Time Frame: 24 hours after surgery

Total opioid consumption will be recorded using intravenous patient-controlled analgesia (PCA) during the first 24 hours after surgery. The cumulative tramadol dose (mg) administered via PCA will be calculated based on the number of patient-controlled bolus doses.

Postoperative Pain Score at Rest and During Movement at 1, 6, 12, and 24 Hours

Time Frame: 24 hours after surgery

Pain intensity will be assessed using the Numeric Rating Scale (NRS), a 0-10 point scale where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at rest and during movement at 1, 6, 12, and 24 hours after surgery. All patients will receive intravenous patient-controlled analgesia (PCA) for postoperative pain management.

Secondary Outcomes

  • Postoperative Pain Scores (NRS) at Rest and During Movement at 1, 6, 12, and 24 Hours(1, 6, 12, and 24 hours after surgery)

Investigators

Sponsor
Konul Karaja
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Konul Karaja

Anesthesiology Research Fellow / MD

Aydin Adnan Menderes University

Study Sites (1)

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