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NCT Number: NCT02671851

Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul University, Department of Anaesthesiology

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III patients who underwent bilateral reduction mammoplasty

Exclusion criteria

  • Patients with deficient data

Treatment and study plan

Thoracic paravertebral blocks (TPVBs)

Drug

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

Drug

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

Other names: Fentanyl,tramadol,metamizole sodium,paracetamol

Primary outcomes

  1. Time to first pain

    Time frame: 0-48 hours

    Postoperative first pain description NRS ≥4

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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