- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517331
Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty
Comparison of Single and Double Injection Ultrasound-Guided Bilateral Thoracic Paravertebral Block Effects in Patients Undergoing Reduction Mammaplasty: A Prospective Randomized Controlled Study
This study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty.
After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The patients were randomized in one of single (Group S: T3-T4) or double injections (Group D: T2-T3&T4-T5) bilateral TPVB groups (bupivacaine 0.375% 20 mL per side). All patients' dermatomal blockade distributions (T2-T6) were followed for 30 minutes, and then they were given general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. Postoperatively, patients in both groups received IV paracetamol 1 g when numeric rating scale (NRS) pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain scores at postoperative 12th hour. The secondary endpoints were NRS scores and dermatomal blockade distributions through the postoperative first 48 hours, postoperative time until first pain, the total numbers of analgesic requirements on days 1 and 2.
Study Overview
Status
Conditions
Detailed Description
This prospective randomized controlled study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty.
After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The inclusion criteria were female gender, aging between 18 and 70 years, American Society of Anesthesiologists (ASA) physical status of 1-3, capable of consenting, understanding the instructions for using the NRS pain scores and replying the study-based questions, lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB, absence of mental/psychiatric disorders, chronic analgesic/opioid use and alcohol/illicit drug use. The patients were randomized in one of single (Group S: T3-T4-bupivacaine 0.375% 20 mL/injection) or double injections (Group D: T2-T3&T4-T5-bupivacaine 0.375% 10 mL/injection) bilateral TPVB groups using the sealed envelopes technique. All patients' dermatomal (sensorial) blockade distributions (T2-T6) were tested bilaterally between T2 and T6 dermatomal levels on the midclavicular line in every 5 minutes through the first 30 minutes after TPVB performances, by using the pin-prick test, and then they were given standard general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. The NRS pain scores (0: no pain and 10: worst pain imaginable), and the dermatomal blockade distribution/numbers of blocked dermatomes of all patients on both sides were asked and documented on postoperative 0th min, 1st, 2nd, 6th, 12th, 24th and 48th hours. Postoperatively, patients in both groups received IV paracetamol 1 g when NRS pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain score at 12th hour. The secondary endpoints included the NRS pain scores and the dermatomal blockade distribution/numbers of blocked dermatomes through the postoperative first 48 hours, block application times, number of patients experienced hypotension or required fentanyl intraoperatively, length of stay in postoperative care unit (PACU), postoperative time until first pain (NRS≥4), the total numbers of paracetamol and tramadol requirements, incidence of postoperative nausea and vomiting (PONV) and duration of sleep on postoperative days 1 and 2, patient and surgeon satisfaction scores.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34093
- Istanbul University, Istanbul Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status of 1-3
- Capable of consenting
- Capable of understanding the instructions for using the NRS pain scores
- Capable of replying the study-based questions
- Lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
- Absence of mental/psychiatric disorders
- Absence of chronic analgesic/opioid use
- Absence of alcohol/illicit drug use
Exclusion Criteria:
- Patient refusal
- American Society of Anesthesiologists (ASA) physical status of 4
- Not capable of consenting
- Not capable of understanding the instructions for using the NRS pain scores
- Not capable of replying the study-based questions
- Contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
- Presence of mental/psychiatric disorders
- Presence of chronic analgesic/opioid use
- Presence of alcohol/illicit drug use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group S (single injection TPVB group)
Patients received bilateral single injection ultrasound-guided TPVB at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side.
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The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
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Active Comparator: Group D (double injection TPVB group)
Patients received bilateral double injection ultrasound-guided TPVB at the level of T2-T3 and T4-T5 with 10 mL bupivacaine 0.375% per injection (20 mL bupivacaine 0.375% per side as the single injection group).
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The blocks were performed at both T2-T3 and T4-T5 levels bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Numeric rating scale (NRS)) score
Time Frame: 12th hour
|
NRS pain score (0: no pain, 10: worst pain imaginable) on postoperative 12th hour
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12th hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Numeric rating scale (NRS)) score
Time Frame: 0-48 hours
|
NRS pain scores (0: no pain, 10: worst pain imaginable) on postoperative 0th min, 1st, 2nd, 6th, 24th and 48th hours on both sides
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0-48 hours
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Dermatomal blockade distribution/numbers of blocked dermatomes
Time Frame: 0-30 minutes
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Preoperatively, the sensorial blockade was tested bilaterally between the T2 and T6 dermatomal levels (4 regions) on the midclavicular line of the patients in every 5 min through the first 30 min after TPVB performances, by using the pin-prick test.
Sensations: "normal", "decreased sensation" or "total anesthesia" separately on both sides.
The answers such as "decreased sensation" or "total anesthesia" in different dermatomal regions within T2-T6 were accepted as "successfully blocked dermatome", and the numbers of blocked dermatomes out of 4 dermatomal regions were noted for the right and the left sides.
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0-30 minutes
|
Dermatomal blockade distribution/numbers of blocked dermatomes
Time Frame: 0-48 hours
|
Postoperatively, the sensorial blockade was tested bilaterally between the T2 and T6 dermatomal levels (4 regions) on the midclavicular line of the patients on postoperative 0th min, 1st, 2nd, 6th, 12th, 24th and 48th hours, by using the pin-prick test.
Sensations: "normal", "decreased sensation" or "total anesthesia" separately on both sides.
The answers such as "decreased sensation" or "total anesthesia" in different dermatomal regions within T2-T6 were accepted as "successfully blocked dermatome", and the numbers of blocked dermatomes out of 4 dermatomal regions were noted for the right and the left sides.
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0-48 hours
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Block application time
Time Frame: 2-20 minutes
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The bilateral TPVB application time was defined as the time period between the needle insertion at the first determined level and the needle withdrawal from the last determined level.
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2-20 minutes
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Number of patients experienced hypotension intraoperatively
Time Frame: Intraoperative 2-4 hours
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The mean arterial pressure (MAP) decreased >20% below preinduction value
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Intraoperative 2-4 hours
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Number of patients required fentanyl intraoperatively
Time Frame: Intraoperative 2-4 hours
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If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 µg/kg) was applied intravenously.
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Intraoperative 2-4 hours
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Length of stay in postoanesthesia care unit (PACU)
Time Frame: 0-1 hours
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Discharge from PACU was determined using the White Fast tracking score ≥12, whereas none of the parameters was <1 in any category
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0-1 hours
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Postoperative time until first pain
Time Frame: 0-48 hours
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Postoperative first pain description (NRS ≥4)
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0-48 hours
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Paracetamol consumption/the total numbers of paracetamol requirements
Time Frame: 0-48 hours
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Paracetamol was used when postoperative pain NRS ≥4 in the postanesthesia care unit or on the wards (on postoperative days 1 and 2)
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0-48 hours
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Tramadol consumption/the total numbers of tramadol requirements
Time Frame: 0-48 hours
|
Tramadol was used when postoperative pain NRS ≥4 again after 1 h of paracetamol application in the postanesthesia care unit or on the wards (on postoperative days 1 and 2)
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0-48 hours
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Incidence of postoperative nausea and vomiting (PONV)
Time Frame: 0-48 hours
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Number of feeling nausea or vomiting (on postoperative days 1 and 2)
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0-48 hours
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Duration of sleep
Time Frame: 0-48 hours
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Total hours of sleep per day (on postoperative days 1 and 2)
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0-48 hours
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Patient satisfaction
Time Frame: 0-48 hours
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Satisfaction score: 0: very unsatisfied, 3: very satisfied
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0-48 hours
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Surgeon satisfaction
Time Frame: 0-48 hours
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Satisfaction score: 0: very unsatisfied, 3: very satisfied
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0-48 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Salviz EA, Sivrikoz N, Ozonur A, Orhan-Sungur M, Savran-Karadeniz M, Altun D, Hocaoglu E, Celet-Ozden B, Tugrul KM. Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anesthesia in Patients Undergoing Reduction Mammaplasty: A Historical Cohort Study. Plast Reconstr Surg. 2017 Jan;139(1):20e-28e. doi: 10.1097/PRS.0000000000002842.
- Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.
- Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/1282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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