Comparison of Erector Spina Plan Block and Rhombodid Intercostal Block in Breast Surgery

Postoperative Pain Clinical Trial

Official title:

Comparison of Erector Spina Plan Block and Rhombodid Intercostal Block for Postoperative Pain Managment in Patients Undergoing Unilateral Breast Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177665
• Other study ID #: KAEK/08.bI.02
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2024
• Source: Kocaeli University
• Contact: Gülnihal Avci
• Phone: +902623038248
• Email: gulnihalavci[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators compared ultrasound-guided erector spinae plane (ESP) block and rhomboid intercostal block (RIB) on postoperative analgesic effect in unilateral breast surgery.

Description:

After being informed about the study and potential risks, written consent was obtained from all patients.Patients who meet eligibility requirements will be randomized in a 1:1 ratio to erector spinae plane block and rhomboid intercostal block.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: May 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patients who will undergo unilateral breast-conserving surgery (BCS) or modified radical mastectomy (MRM) with or without axillary lymph node dissection

• Patients undergoing elective surgery

• ASA (American Society of Anesthesiologists) physical status classification I-III

Exclusion Criteria:

• Use of anticoagulants

• Allergy to the medications to be used

• Patients who use analgesic drugs due to a history of chronic pain

• ASA (American Society of Anesthesiologists) physical status classification IV-V

• Patients with psychiatric disorders

• Presence of infection in the area where the block will be applied

• Presence of deformity in the patient's spinal, paraspinal and area where the block will be applied

• The patient does not accept the block application or cannot cooperate with the patient

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Erector Spinae Plane Block
Ultrasound(US)-guided erector spinae plan block(ESP) with 20 ml 0,25% bupivacaine at T4 vertebra level will performe preoperatively to all patients in the ESP group.
• Rhomboid Intercostal Block
Ultrasound(US)-guided rhomboid intercostal block(RIB) with 20 ml 0,25% bupivacaine at T5-T6 vertebra level will performe preoperatively to all patients in the RIB group.

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphin Consumption	Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia	during postoperative 24 hours
Secondary	Numerical Rating Scale(NRS)	A numerical rating scale(NRS) requires the patient to rate their pain on defined scale.For example , 0-10 where 0 is no pain and 10 is the worst pain imaginable.	during postoperative 24 hours

External Links

•   Comparison of rhomboid intercostal nerve block, erector spinae plane block and serratus plane block on analgesia for modified radical mastectomy: A prospective randomised controlled trial.
•   Rhomboid intercostal block
•   Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review