Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty

February 9, 2016 updated by: Emine Aysu Salviz, MD, Istanbul University

Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anaesthesia in Patients Undergoing Reduction Mammoplasty: A Historical Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul University, Department of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female patients undergoing bilateral reduction mammoplasty

Description

Inclusion Criteria:

  • ASA I-III patients who underwent bilateral reduction mammoplasty

Exclusion Criteria:

  • Patients with deficient data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Fentanyl,tramadol,metamizole sodium,paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first pain
Time Frame: 0-48 hours
Postoperative first pain description NRS ≥4
0-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fentanyl use
Time Frame: During the surgery
Intraoperative fentanyl was used if heart rate or mean arterial pressure increased >20% above preinduction values
During the surgery
Tramadol use
Time Frame: 0-2 hours
Postoperative pain NRS ≥4 in the postoperative care unit
0-2 hours
Rescue analgesic requirement
Time Frame: 0-48 hours
Postoperative pain NRS ≥4 on the wards
0-48 hours
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
0-2 hours
Pain (NRS) scores
Time Frame: 0-48 hours
Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
0-48 hours
Incidence of Postoperative nausea and vomiting (PONV)
Time Frame: 0-48 hours
Incidence of PONV
0-48 hours
Patient satisfaction (Satisfaction scores)
Time Frame: 0-48 hours
Satisfaction scores (0: very unsatisfied, 3: very satisfied)
0-48 hours
Surgeon satisfaction (Satisfaction scores)
Time Frame: 0-48 hours
Satisfaction scores (0: very unsatisfied, 3: very satisfied)
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Emine A Salviz, MD, Design and conduct the study, review and analyze the data, and write the manuscript

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/83

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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