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Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty

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ClinicalTrials.gov Identifier: NCT02671851
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Emine Aysu Salviz, MD, Istanbul University

Brief Summary:

Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.

Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.

Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.

Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20% above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards (NRS≥4).

Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.


Condition or disease Intervention/treatment
Pain, Postoperative Drug: Thoracic paravertebral blocks (TPVBs) Drug: IV metamizole sodium, paracetamol

Detailed Description:

Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.

Objective: The objective was to assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.

Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammaplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.

Intervention: Standard monitoring was applied before any anesthetic techniques were performed. All patients were given sedation in the form of midazolam 1-2 mg and fentanyl 50-100 µg. Patients underwent bilateral reduction mammaplasty were distributed to two groups due to their data: 1) Patients received only general anaesthesia (GA) were included in Group GA, and 2) Patients received preoperative US-guided TPVBs as an adjunct to GA were included in Group TPVBs. Thirty patients were in Group GA. Thirty-four patients who were in Group TPVBs received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% (20 mL per injection) at the level of T3-4, as an adjunct to GA. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20% above pre-induction values. They also received postoperative tramadol 1mg/kg in the postoperative care unit (PACU) and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards, if numeric rating scale (NRS) was ≥4.

Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.


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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anaesthesia in Patients Undergoing Reduction Mammoplasty: A Historical Cohort Study
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dipyrone

Group/Cohort Intervention/treatment
Thoracic paravertebral blocks (TPVBs)
Patients received bilateral single injection ultrasound-guided TPVBs at the level of T3-T4 with 20 mL bupivacaine 0.375% as an adjunct to general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.
Drug: Thoracic paravertebral blocks (TPVBs)
Patients received bilateral single injection ultrasound-guided TPVBs with 20mL bupivacaine 0.375% at the level of T3-T4 as an adjunct to GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
Other Name: Bupivacaine,fentanyl,tramadol,metamizole sodium,paracetamol

IV metamizole sodium, paracetamol
Patients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.
Drug: IV metamizole sodium, paracetamol
Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
Other Name: Fentanyl,tramadol,metamizole sodium,paracetamol




Primary Outcome Measures :
  1. Time to first pain [ Time Frame: 0-48 hours ]
    Postoperative first pain description NRS ≥4


Secondary Outcome Measures :
  1. Fentanyl use [ Time Frame: During the surgery ]
    Intraoperative fentanyl was used if heart rate or mean arterial pressure increased >20% above preinduction values

  2. Tramadol use [ Time Frame: 0-2 hours ]
    Postoperative pain NRS ≥4 in the postoperative care unit

  3. Rescue analgesic requirement [ Time Frame: 0-48 hours ]
    Postoperative pain NRS ≥4 on the wards

  4. Length of stay in the PACU [ Time Frame: 0-2 hours ]
    White's Fast-Tracking Scoring System ≥12 was used for PACU discharge with no score of <1 in any category

  5. Pain (NRS) scores [ Time Frame: 0-48 hours ]
    Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)

  6. Incidence of Postoperative nausea and vomiting (PONV) [ Time Frame: 0-48 hours ]
    Incidence of PONV

  7. Patient satisfaction (Satisfaction scores) [ Time Frame: 0-48 hours ]
    Satisfaction scores (0: very unsatisfied, 3: very satisfied)

  8. Surgeon satisfaction (Satisfaction scores) [ Time Frame: 0-48 hours ]
    Satisfaction scores (0: very unsatisfied, 3: very satisfied)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients undergoing bilateral reduction mammoplasty
Criteria

Inclusion Criteria:

  • ASA I-III patients who underwent bilateral reduction mammoplasty

Exclusion Criteria:

  • Patients with deficient data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671851


Locations
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Turkey
Istanbul University, Department of Anaesthesiology
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Emine A Salviz, MD Design and conduct the study, review and analyze the data, and write the manuscript

Publications of Results:
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Responsible Party: Emine Aysu Salviz, MD, M.D., Attending Anesthesiologist, Istanbul University
ClinicalTrials.gov Identifier: NCT02671851     History of Changes
Other Study ID Numbers: 2016/83
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Emine Aysu Salviz, MD, Istanbul University:
Thoracic Paravertebral Blocks
Ultrasound Guidance
Reduction Mammoplasty
Time to First Pain
Postoperative Analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Dipyrone
Fentanyl
Tramadol
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents