Paravertebral Block Versus Erector Spinae Plane Block for Analgesia in Modified Radical Mastectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TPVB
ESPB
Bupivacain
Sponsored by

About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Acute postoperative pain, Nerve block, Thoracic wall
Eligibility Criteria
Inclusion Criteria:
- unilateral MRM
- ages 18-75 years
- American Society of Anesthesiologists (ASA) classification I-III
Exclusion Criteria:
- presence of contraindications for using regional anesthesia (not having patient approval, presence of bleeding-clotting disorders, infection at the injection site, local anesthetic allergy)
- chronic analgesic use
- diabetes mellitus
- body mass index of (BMI) > 35 kg/m2.
Sites / Locations
- Istanbul University, Istanbul Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group P : TPVB
Group E : ESPB
Arm Description
Thoracic paravertebral block
Erector spinae plane block
Outcomes
Primary Outcome Measures
Morphine consumption
amount of postoperative 24 hours morphine consumption
Secondary Outcome Measures
Static and dynamic pain score assessed with Numeric Rating Scale (NRS).
Pain scores will be noted postoperative at 0, 30 minutes and 1,4,6,12,24 hours. NRS=0 (minimum value, no pain). NRS=10 (maximum value, worst pain imaginable).
intraoperative heart rate
starting from induction to extubation (beat/min)
intraoperative mean arterial pressure
starting from induction to extubation (mmHg)
nause and vomit
Assessed with Postoperative Nause and Vomit (PONV) Scale. (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once)
number of blocked dermatome
pinprick test in mid-axillar and mid-clavicular line
Full Information
NCT ID
NCT05080985
First Posted
September 15, 2021
Last Updated
October 4, 2021
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT05080985
Brief Title
Paravertebral Block Versus Erector Spinae Plane Block for Analgesia in Modified Radical Mastectomy
Official Title
Paravertebral Block Versus Erector Spinae Plane Block for Analgesia and Opioid Consumption in Modified Radical Mastectomy; Randomized, Prospective, Double Blind
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul 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 study is planned to be a single-center randomized, prospective double-blind study and includes patients who planned to be done unilateral MRM (modified radical mastectomy) operation in Istanbul University Istanbul Faculty of Medicine. The objective of this study is to compare postoperative analgesic efficacies of TPVB (thoracic paravertebral block) and ESPB (erector spinae plane block) performed under ultrasound (USG) guidance after MRM. Primary outcome of this study is postoperative 24-hour morphine consumption whereas secondary outcomes were planned as the comparison of changes in hemodynamic parameters and numeric rating pain score (NRS).
Detailed Description
A total of 86 patients were randomized into TPVB (Group P) and ESPB (Group E) by using closed envelopes.
All patients in the operating room has same anesthetic management under standard monitoring modalities. Prior to regional technique, mild sedation was achieved with midazolam (1-2 mg) and fentanyl (50 mcg). Both blocks were performed under ultrasonography guidance from the level of T4 vertebra with a linear probe (5MHz; GE Healthcare, Wauwatosa, Wis, USA) using longitudinally out-of-plane technique by an anesthesiologist. A 22-gauge, 50 mm insulated stimulating needle was used.By using reference points of C7 and T7, spinous processes of thoracic vertebras were marked. 10% povidone iodine was used for skin antisepsis. USG probe was longitudinally placed at the level of T4. Staff anesthesiologist had to visualize of adjacent muscles, transverse process (TP) and pleura.
For ESPB; confirmation of the needle position was achieved with spread of 2 ml saline between the deep fascia of the erector spinae muscle and the TP. After negative aspiration 20 ml 0.375% bupivacaine was injected with appropriate distribution of LA.
For TPVB; the needle was advanced passing over superior costotransverse ligament and target space was confirmed by the downward displacement of pleura after the administration of 2 ml 0.9% NaCl. After negative aspiration, 20 ml 0.375 % bupivacaine was injected with appropriate distribution of local anesthetics.
Vascular puncture, haematoma, neuraxial injury and pneumothorax were defined as block complications and should be noted.
30 minutes after the block achieved, pinprick test was performed on both mid-axillary and midclavicular lines from T1 to T12 (0 there is sensation, 1 decreased sensation, 2 there is no sensation).
Anesthesia induction was unique for all patients with 0.03 mg kg-1 midazolam, 0.5 mcg kg-1 fentanyl, 2 mg kg-1 propofol and 0.6 mg kg-1 rocuronium. Maintenance was achieved with sevoflurane of 1 minimum alveolar concentration in a mixture of 40% O2 and 60% N2O. As a component of multimodal analgesia, paracetamol (1 gr) was applied to all patients before skin incision.
Hemodynamic data were recorded throughout surgery. An increase more than 20% from baseline in mean arterial pressure (MAP) was defined as inadequate analgesia and was treated with bolus fentanyl (50 mcg). Hypotension was described with a decrease more than 20% in MAP and treated with ephedrine bolus. Bradycardia was determined with a heart rate (HR) less than 50 beats min-1 and treated with atropine. At the end of surgery, the patients were extubated in operating room.
Postoperative analgesia was achieved with IV morphine via Patient Controlled Analgesia (PCA) for 24 hours (0.01 mg kg-1 h-1 basal infusion, 1 mg bolus, 20 minutes lock-out time).
Postoperative follow-up included hemodynamic variables as well as pain scores and morphine consumption. Adequate analgesia at rest (static) and at moving of the arm interpreted as 45-90 degree abduction (dynamic) was investigated with Numeric Rating Scale (NRS) at 30th minute and 1st, 4th, 6th, 12th, 24th hours postoperatively. When NRS was 4 and higher, tramadol should be administered as rescue analgesic. In case of insufficient pain control at 30th minute, dermatomal analgesia should be assessed for both mid-axillary and midclavicular lines from T1 to T8 by pinprick test (0 there is sensation, 1 decreased sensation, 2 there is no sensation). Morphine consumption was evaluated at same study times.
Complications were determined as sedation assessed by Ramsey scale, postoperative nausea- vomiting (PONV) assessed with the four-point categorical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once). Severe vomiting should be treated in a multimodal way and excluded from the study (category 2,3).
Staff anesthesiologist responsible for operative course did not contribute in analgesia assessment, nor in other postoperative follow-up. Other investigators who were blinded to operative management, collected postoperative data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Acute postoperative pain, Nerve block, Thoracic wall
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group P : TPVB
Arm Type
Experimental
Arm Description
Thoracic paravertebral block
Arm Title
Group E : ESPB
Arm Type
Experimental
Arm Description
Erector spinae plane block
Intervention Type
Procedure
Intervention Name(s)
TPVB
Intervention Description
20 ml 0.375 % bupivacaine was injected between superior costotransverse ligament and pleura.
Intervention Type
Procedure
Intervention Name(s)
ESPB
Intervention Description
20 ml 0.375 % bupivacaine was injected between deep fascia of the erector spinae muscle and transverse process.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
20 ml 0.375 % bupivacaine was injected
Primary Outcome Measure Information:
Title
Morphine consumption
Description
amount of postoperative 24 hours morphine consumption
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
Static and dynamic pain score assessed with Numeric Rating Scale (NRS).
Description
Pain scores will be noted postoperative at 0, 30 minutes and 1,4,6,12,24 hours. NRS=0 (minimum value, no pain). NRS=10 (maximum value, worst pain imaginable).
Time Frame
postoperative 24 hours
Title
intraoperative heart rate
Description
starting from induction to extubation (beat/min)
Time Frame
during surgery
Title
intraoperative mean arterial pressure
Description
starting from induction to extubation (mmHg)
Time Frame
during surgery
Title
nause and vomit
Description
Assessed with Postoperative Nause and Vomit (PONV) Scale. (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once)
Time Frame
postoperative 24 hours
Title
number of blocked dermatome
Description
pinprick test in mid-axillar and mid-clavicular line
Time Frame
30 minutes after block
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral MRM
ages 18-75 years
American Society of Anesthesiologists (ASA) classification I-III
Exclusion Criteria:
presence of contraindications for using regional anesthesia (not having patient approval, presence of bleeding-clotting disorders, infection at the injection site, local anesthetic allergy)
chronic analgesic use
diabetes mellitus
body mass index of (BMI) > 35 kg/m2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nükhet Sivrikoz
Organizational Affiliation
Attending anesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
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Paravertebral Block Versus Erector Spinae Plane Block for Analgesia in Modified Radical Mastectomy
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