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

February 5, 2020 updated by: Onur Balaban, MD, Kutahya Health Sciences University

Comparison of Rhomboid Intercostal Block and Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postoperative analgesia in breast surgery is important in reducing morbidity and mortality. Intravenous or oral analgesics may be used for this purpose. Ultrasound-guided fascia plane blocks are used to provide effective analgesia in mastectomy operations. 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. Both blocks have the advantage of unilateral application in unilateral mastectomy operations. When administered pre-operatively, it also provides per-operative analgesia and may reduce per-operative opioid consumption. These blocks are applied under ultrasound-guidance with single injection. Since the site of injection is relatively superficial (between the back muscles and ribs) and applied under ultrasound-guidance, mechanical complications is expected to occur less. These low-cost blocks also may reduce the usage of high-cost and high-risk opioids after surgery. These blocks unilaterally anesthetize the nerves innervating the thoracic region and the axilla, thus providing effective per-operative and post-operative analgesia in mastectomy operations.

The aim of our study is to compare the rhomboid intercostal block with erector spina plane block in mastectomy in terms of intraoperative and postoperative analgesia in mastectomy operation. Our hypothesis is rhomboid intercostal block may reduce peri-operative pain as effective as or more effectively than erector spina plane block. Secondary hypothesis is rhomboid intercostal block may reduce peri-operative opioid consumption as effective as or more effectively than erector spina plane block. Thus, the study is defined as block technique comparison.

Eighty patients aged between 29-79 years who are planned mastectomy under general anesthesia will be included in the study. Patients with severe cardiac and respiratory disease, severe coagulation disorder, body mass index greater than 35, refusal of regional block and patients having local infection in block application area, contraindication of the standardized drugs in the study and patients with insufficient postoperative analgesia requiring more potent opioids will be excluded from the study.

The patients who meet the study criteria will be assigned into two groups by using computerized randomization. Patients who do not give consent will also be excluded from the study. All patients will be sedated with midazolam and fentanyl prior to block application. First group (RIB-Group) of patients will receive ultrasound-guided rhomboid intercostal block prior to the operation under sedation. Patients in the second group (ESP-Group) will receive ultrasound-guided erector spina plane block under sedation. Since both procedures will be performed from the same site, the study was considered as a single blind.

All patients will be intubated after induction of general anesthesia with Propofol 2 mg / kg, Rocuronium 0.6 mg / kg and Fentanyl 1.5 µg / kg. Mixture of Desflurane 6% concentration in 50% air and 50% oxygen will be used for the maintenance of general anesthesia. Patients in both groups will receive 1 µg / kg of fentanyl when pain occurs during surgery. Pre-operative and post-operative blood pressure, heart rate, oxygen saturation, end-tidal carbon dioxide values of patients in both groups will be measured and recorded at determined time intervals.

Patients will be followed for 48 hours after the operation. In the postoperative period, acetaminophen 1 g three times a day will be administered routinely in context of multimodal analgesia. Intravenous tramadol 1 mg/kg will also be administered depending on patient need up to 4 times a day. Total amount of perioperative opioids will be recorded. Per-operative and post-operative opioid consumption will be calculated separately. Pain assessment will be evaluated by using a verbal analog scale (asking patients to give a pain score between 0 and 10. Score of 0 means worse pain ever and score of 10 means no pain). Complications related to the block procedure will be also recorded. If there is pain that requires more potent opioids such as morphine, the block will be considered as unsuccessful.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Merkez
      • Kutahya, Merkez, Turkey, 43040
        • Kutahya Health Sciences University
        • Sub-Investigator:
          • Miray K Turgut, MD.
        • Contact:
        • Sub-Investigator:
          • Tayfun Aydın, MD.
        • Sub-Investigator:
          • Buse Kozlu, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

29 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are planned mastectomy under general anesthesia

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIB Group
A single injection Rhomboid intercostal block will be performed under ultrasound guidance
Procedure: Rhomboid intercostal block
The block is regional anesthesia injection techniques performed under ultrasound guidance.
Active Comparator: ESP Group
A single injection Erector spinae plane block will be performed under ultrasound guidance
Procedure: Erector spinae plane block
The block is regional anesthesia injection techniques performed under ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Throughout post-operative course, up to 48 hours
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
Time Frame: At the end of the operation
Fentanyl consumption
At the end of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 48th postoperative hour
Total tramadol consumption
48th postoperative hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Investigators

  • Principal Investigator: Onur Balaban, MD., Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/06RIBVSESP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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