Rhomboid Intercostal Block vs Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy

NCT04259502 | Unknown

• 1 other identifier: 2019/06RIBVSESP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Effectiveness of erector spinae plane block for analgesia in breast surgery was documented in previous studies. Rhomboid intercostal block may be beneficial for analgesia in breast surgery. The aim of this study is to compare the peri-operative analgesic effect of rhomboid intercostal block with erector spinae plane block in mastectomy operation. This trial was designed as prospective randomized single-blind study. The included patients will be assigned into two groups: RIB-Group where the patients will receive ultrasound-guided rhomboid intercostal block and ESP-Group where the patients will receive ultrasound-guided erector spinae plane block prior to the operation. Primary outcome will be peri-operative pain scores and secondary outcomes will be peri-operative opioid consumption and peri-operative hemodynamic effect of these blocks.

Conditions

Analgesia; Perioperative Analgesia; Postoperative Analgesia

Keywords

Postoperative Analgesia; Peroperative Analgesia; Ultrasound; Rhomboid intercostal block; Erector spinae plane block; Mastectomy

Outcome Measures

Primary Outcomes (2)

• Pain score

  Subjective pain score reported by the patient, assessed by a blinded investigator to the study; which is defined as the score in a scale between minimum value of zero and maximum value of 10 (higher scores mean a better outcome).

  Throughout post-operative course, up to 48 hours

• Peroperative Analgesia

  Fentanyl consumption

  At the end of the operation

Secondary Outcomes (1)

• Opioid consumption

  48th postoperative hour

Study Arms (2)

RIB Group

EXPERIMENTAL

A single injection Rhomboid intercostal block will be performed under ultrasound guidance

Procedure: Rhomboid intercostal block

ESP Group

ACTIVE COMPARATOR

A single injection Erector spinae plane block will be performed under ultrasound guidance

Procedure: Erector spinae plane block

Interventions

Rhomboid intercostal block PROCEDURE

The block is regional anesthesia injection techniques performed under ultrasound guidance.

RIB Group

Erector spinae plane block PROCEDURE

The block is regional anesthesia injection techniques performed under ultrasound guidance.

ESP Group

Eligibility Criteria

• Age: 29 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are planned mastectomy under general anesthesia

You may not qualify if:

• Patients with severe cardiac and respiratory disease
• Severe coagulation disorder
• Body mass index greater than 35 kg/m2
• Refusal of regional block
• Patients having local infection in block application area
• Contraindication of the standardized drugs in the study
• Insufficient postoperative analgesia requiring more potent opioids

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Merkez, 43040, Turkey (Türkiye)

Location

Related Publications (11)

• Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.

  PMID: 27291611 BACKGROUND

• Balaban O, Aydin T. A modified approach of rhomboid intercostal block for postoperative analgesia in modified radical mastectomy: Ultrasound guided bi-level high thoracic injection. J Clin Anesth. 2019 Nov;57:29-30. doi: 10.1016/j.jclinane.2019.03.002. Epub 2019 Mar 6. No abstract available.

  PMID: 30851500 BACKGROUND

• Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.

  PMID: 30851503 BACKGROUND

• Tulgar S, Selvi O, Thomas DT, Manukyan M, Ozer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. No abstract available.

  PMID: 30553225 BACKGROUND

• Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.

  PMID: 30988534 BACKGROUND

• Selvi O, Tulgar S. Use of the Ultrasound-Guided Erector Spinae Plane Block in Segmental Mastectomy. Turk J Anaesthesiol Reanim. 2019 Apr;47(2):158-160. doi: 10.5152/TJAR.2019.50024. Epub 2019 Jan 29.

  PMID: 31080959 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Kimachi PP, Martins EG, Peng P, Forero M. The Erector Spinae Plane Block Provides Complete Surgical Anesthesia in Breast Surgery: A Case Report. A A Pract. 2018 Oct 1;11(7):186-188. doi: 10.1213/XAA.0000000000000777.

  PMID: 29688930 BACKGROUND

• Aksu C, Kus A, Yorukoglu HU, Tor Kilic C, Gurkan Y. Analgesic effect of the bi-level injection erector spinae plane block after breast surgery: A randomized controlled trial. Agri. 2019 Jul;31(3):132-137. doi: 10.14744/agri.2019.61687.

  PMID: 31736025 BACKGROUND

• Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.

  PMID: 30396100 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.

  PMID: 31280100 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Onur Balaban, MD.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Onur Balaban, MD.

CONTACT

+90 274 231 6660; obalabandr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The two interventions will be performed at the same thoracic region using the same technique as so; there participant will be blinded to the study. The investigator who performs the intervention will be unblinded. The investigator who will follow up the patients and collect the postoperative pain data will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistan Professor, MD.

Model Details: The patients included in the study will be assigned to one group of two in which two different regional block technique will be performed alone.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 6, 2020
• Study Start: February 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

TU (1)