Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty
- Conditions
- Pain, Postoperative
- Interventions
- Drug: Thoracic paravertebral blocks (TPVBs)Drug: IV metamizole sodium, paracetamol
- Registration Number
- NCT02671851
- Lead Sponsor
- Istanbul University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 64
- ASA I-III patients who underwent bilateral reduction mammoplasty
- Patients with deficient data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Thoracic paravertebral blocks (TPVBs) 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. IV metamizole sodium, paracetamol IV metamizole sodium, paracetamol Patients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.
- Primary Outcome Measures
Name Time Method Time to first pain 0-48 hours Postoperative first pain description NRS ≥4
- Secondary Outcome Measures
Name Time Method Rescue analgesic requirement 0-48 hours Postoperative pain NRS ≥4 on the wards
Pain (NRS) scores 0-48 hours Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
Fentanyl use During the surgery Intraoperative fentanyl was used if heart rate or mean arterial pressure increased \>20% above preinduction values
Tramadol use 0-2 hours Postoperative pain NRS ≥4 in the postoperative care unit
Incidence of Postoperative nausea and vomiting (PONV) 0-48 hours Incidence of PONV
Patient satisfaction (Satisfaction scores) 0-48 hours Satisfaction scores (0: very unsatisfied, 3: very satisfied)
Surgeon satisfaction (Satisfaction scores) 0-48 hours Satisfaction scores (0: very unsatisfied, 3: very satisfied)
Length of stay in the PACU 0-2 hours White's Fast-Tracking Scoring System ≥12 was used for PACU discharge with no score of \<1 in any category
Trial Locations
- Locations (1)
Istanbul University, Department of Anaesthesiology
🇹🇷Istanbul, Turkey