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Clinical Trials/NCT02671851
NCT02671851
Completed
Not Applicable

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

Istanbul University1 site in 1 country64 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Thoracic paravertebral blocks (TPVBs)
Conditions
Pain, Postoperative
Sponsor
Istanbul University
Enrollment
64
Locations
1
Primary Endpoint
Time to first pain
Status
Completed
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
January 2016
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emine Aysu Salviz, MD

M.D., Attending Anesthesiologist

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • ASA I-III patients who underwent bilateral reduction mammoplasty

Exclusion Criteria

  • Patients with deficient data

Arms & Interventions

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.

Intervention: Thoracic paravertebral blocks (TPVBs)

IV metamizole sodium, paracetamol

Patients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.

Intervention: IV metamizole sodium, paracetamol

Outcomes

Primary Outcomes

Time to first pain

Time Frame: 0-48 hours

Postoperative first pain description NRS ≥4

Secondary Outcomes

  • Rescue analgesic requirement(0-48 hours)
  • Pain (NRS) scores(0-48 hours)
  • Fentanyl use(During the surgery)
  • Tramadol use(0-2 hours)
  • Incidence of Postoperative nausea and vomiting (PONV)(0-48 hours)
  • Patient satisfaction (Satisfaction scores)(0-48 hours)
  • Surgeon satisfaction (Satisfaction scores)(0-48 hours)
  • Length of stay in the PACU(0-2 hours)

Study Sites (1)

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