Back to resultsThoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thoracic Paravertebral Block
Rhomboid Block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Thoracic surgery, Postoperative pain, Rhomboid block, Paravertebral block
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for general thoracic surgery
- ASA I-III
Exclusion Criteria:
- Patients without consent
- Emergency surgeries
- Pregnancy
- Coagulopathies and bleeding diathesis
- Allergy to local anesthetics
- Local skin infection at the puncture site
Sites / Locations
- Koç University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group I
Group II
Arm Description
Group I will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve paravertebral block which is already proven to be effective in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, paravertebral block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the paravertebral space at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).
Group II will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve rhomboid block which is being experimented for its efficacy in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, rhomboid block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the plane between rhomboid muscle and intercostal muscles, medial to scapula at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).
Outcomes
Primary Outcome Measures
Difference in Visual Analogue Scale (VAS) scores between two groups
Statistically significant difference in VAS scores at 1st, 3rd, 6th, 12th, 24th hours between two groups. On a scale of 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Difference in additional analgesic usage between two groups
Intravenous patient controlled analgesia usage and additional analgesic dosages will be filed as miligrams or micrograms at 1st, 3rd, 6th, 12th, 24th hours.
Secondary Outcome Measures
Incidence of nausea and vomiting
Incidence of symptoms like nausea and vomiting will be filed at 1st, 3rd, 6th, 12th, 24th hours. On a scale of 0 to 1, where 0 means no symptoms and 1 means nausea and vomiting.
Patient satisfaction
Patient will be reevaluated at 24th hour for analgesic satisfaction. On a scale of 0 to 3, where 0 means not satisfied and 3 means satisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05061667
Brief Title
Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
Official Title
Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koç University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries.
Detailed Description
Patients with scheduled thoracic surgery are going to be enrolled for this study. Patients will be randomized and separated in two groups. Group I will receive thoracic paravertebral block, group II will receive rhomboid block. Each group will receive patient controlled analgesia with intravenous fentanyl. Patients will be monitored at postoperative 1st, 3rd, 6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total analgesic usage, additional analgesic need and time of the first report of pain will be filed. Then the two groups will be compared and evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Thoracic surgery, Postoperative pain, Rhomboid block, Paravertebral block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Group I will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve paravertebral block which is already proven to be effective in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, paravertebral block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the paravertebral space at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).
Arm Title
Group II
Arm Type
Experimental
Arm Description
Group II will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve rhomboid block which is being experimented for its efficacy in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, rhomboid block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the plane between rhomboid muscle and intercostal muscles, medial to scapula at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).
Intervention Type
Procedure
Intervention Name(s)
Thoracic Paravertebral Block
Other Intervention Name(s)
TPVB
Intervention Description
Paravertebral block for postoperative analgesia in thoracic surgery
Intervention Type
Procedure
Intervention Name(s)
Rhomboid Block
Intervention Description
Rhomboid block for postoperative analgesia in thoracic surgery
Primary Outcome Measure Information:
Title
Difference in Visual Analogue Scale (VAS) scores between two groups
Description
Statistically significant difference in VAS scores at 1st, 3rd, 6th, 12th, 24th hours between two groups. On a scale of 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Time Frame
24 hours
Title
Difference in additional analgesic usage between two groups
Description
Intravenous patient controlled analgesia usage and additional analgesic dosages will be filed as miligrams or micrograms at 1st, 3rd, 6th, 12th, 24th hours.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Incidence of nausea and vomiting
Description
Incidence of symptoms like nausea and vomiting will be filed at 1st, 3rd, 6th, 12th, 24th hours. On a scale of 0 to 1, where 0 means no symptoms and 1 means nausea and vomiting.
Time Frame
24 hours
Title
Patient satisfaction
Description
Patient will be reevaluated at 24th hour for analgesic satisfaction. On a scale of 0 to 3, where 0 means not satisfied and 3 means satisfied.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for general thoracic surgery
ASA I-III
Exclusion Criteria:
Patients without consent
Emergency surgeries
Pregnancy
Coagulopathies and bleeding diathesis
Allergy to local anesthetics
Local skin infection at the puncture site
Facility Information:
Facility Name
Koç University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g., meta-analyses), upon request to the corresponding author, and with a signed data access agreement.
IPD Sharing Time Frame
6 months after the publication
IPD Sharing Access Criteria
Academic purposes
Citations:
PubMed Identifier
33198430
Citation
Ciftci B, Ekinci M, Atalay YO. Ultrasound-guided rhomboid intercostal block provides effective pain control after video-assisted thoracoscopic surgery: a brief report of three cases. Korean J Anesthesiol. 2021 Aug;74(4):355-357. doi: 10.4097/kja.20538. Epub 2020 Nov 17. No abstract available.
Results Reference
background
PubMed Identifier
32470838
Citation
Longo F, Piliego C, Martuscelli M, Tomaselli E, Crucitti P, Longo F, Agro FE. Rhomboid intercostal and subserratus plane block for intubated uniportal video-assisted thoracoscopic surgery lobectomy. J Clin Anesth. 2020 Oct;65:109881. doi: 10.1016/j.jclinane.2020.109881. Epub 2020 May 26. No abstract available.
Results Reference
background
PubMed Identifier
31668692
Citation
Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available. Erratum In: J Clin Anesth. 2020 Aug;63:109789.
Results Reference
background
Learn more about this trial
Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
We'll reach out to this number within 24 hrs