search
Back to results

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

Primary Purpose

Analgesia, Perioperative Analgesia, Postoperative Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rhomboid intercostal block
Erector spinae plane block
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Postoperative Analgesia, Peroperative Analgesia, Ultrasound, Rhomboid intercostal block, Erector spinae plane block, Mastectomy

Eligibility Criteria

29 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kutahya Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RIB Group

ESP Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
Peroperative Analgesia
Fentanyl consumption

Secondary Outcome Measures

Opioid consumption
Total tramadol consumption

Full Information

First Posted
January 13, 2020
Last Updated
February 5, 2020
Sponsor
Kutahya Health Sciences University
search

1. Study Identification

Unique Protocol Identification Number
NCT04259502
Brief Title
Rhomboid Intercostal Block vs Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy
Official Title
Comparison of Rhomboid Intercostal Block and Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Perioperative Analgesia, Postoperative Analgesia
Keywords
Postoperative Analgesia, Peroperative Analgesia, Ultrasound, Rhomboid intercostal block, Erector spinae plane block, Mastectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIB Group
Arm Type
Experimental
Arm Description
A single injection Rhomboid intercostal block will be performed under ultrasound guidance
Arm Title
ESP Group
Arm Type
Active Comparator
Arm Description
A single injection Erector spinae plane block will be performed under ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
Rhomboid intercostal block
Intervention Description
The block is regional anesthesia injection techniques performed under ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
The block is regional anesthesia injection techniques performed under ultrasound guidance.
Primary Outcome Measure Information:
Title
Pain score
Description
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).
Time Frame
Throughout post-operative course, up to 48 hours
Title
Peroperative Analgesia
Description
Fentanyl consumption
Time Frame
At the end of the operation
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Total tramadol consumption
Time Frame
48th postoperative hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onur Balaban, MD.
Phone
+90 274 231 6660
Email
obalabandr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur Balaban, MD.
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kutahya Health Sciences University
City
Kutahya
State/Province
Merkez
ZIP/Postal Code
43040
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onur Balaban, MD.
Phone
+90 274 231 6660
Email
obalabandr@gmail.com
First Name & Middle Initial & Last Name & Degree
Tayfun Aydın, MD.
First Name & Middle Initial & Last Name & Degree
Buse Kozlu, MD.
First Name & Middle Initial & Last Name & Degree
Miray K Turgut, MD.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27291611
Citation
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.
Results Reference
background
PubMed Identifier
30851500
Citation
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.
Results Reference
background
PubMed Identifier
30851503
Citation
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.
Results Reference
background
PubMed Identifier
30553225
Citation
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.
Results Reference
background
PubMed Identifier
30988534
Citation
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.
Results Reference
background
PubMed Identifier
31080959
Citation
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.
Results Reference
background
PubMed Identifier
29980005
Citation
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.
Results Reference
background
PubMed Identifier
29688930
Citation
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.
Results Reference
background
PubMed Identifier
31736025
Citation
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.
Results Reference
background
PubMed Identifier
30396100
Citation
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.
Results Reference
background
PubMed Identifier
31280100
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs