Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Thoracic paravertebral blocks (TPVBs)
* Drug: IV metamizole sodium, paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III patients who underwent bilateral reduction mammoplasty Exclusion Criteria: Patients with deficient data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thoracic paravertebral blocks (TPVBs)<br>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)<br>* 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.<br>* Other names: Bupivacaine,fentanyl,tramadol,metamizole sodium,paracetamol;|
| IV metamizole sodium, paracetamol<br>Patients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics. | Drug: IV metamizole sodium, paracetamol<br>* Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.<br>* Other names: Fentanyl,tramadol,metamizole sodium,paracetamol;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Paravertebral Blocks, Ultrasound Guidance, Reduction Mammoplasty, Time to First Pain, Postoperative Analgesia