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Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty

NCT02671851 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2016-02-10

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

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.

DRUG

IV metamizole sodium, paracetamol

Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02671851 on ClinicalTrials.gov