Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-12-31

Brief Summary

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This study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty.

After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The patients were randomized in one of single (Group S: T3-T4) or double injections (Group D: T2-T3\&T4-T5) bilateral TPVB groups (bupivacaine 0.375% 20 mL per side). All patients' dermatomal blockade distributions (T2-T6) were followed for 30 minutes, and then they were given general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. Postoperatively, patients in both groups received IV paracetamol 1 g when numeric rating scale (NRS) pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain scores at postoperative 12th hour. The secondary endpoints were NRS scores and dermatomal blockade distributions through the postoperative first 48 hours, postoperative time until first pain, the total numbers of analgesic requirements on days 1 and 2.

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Detailed Description

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This prospective randomized controlled study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty.

After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The inclusion criteria were female gender, aging between 18 and 70 years, American Society of Anesthesiologists (ASA) physical status of 1-3, capable of consenting, understanding the instructions for using the NRS pain scores and replying the study-based questions, lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB, absence of mental/psychiatric disorders, chronic analgesic/opioid use and alcohol/illicit drug use. The patients were randomized in one of single (Group S: T3-T4-bupivacaine 0.375% 20 mL/injection) or double injections (Group D: T2-T3\&T4-T5-bupivacaine 0.375% 10 mL/injection) bilateral TPVB groups using the sealed envelopes technique. All patients' dermatomal (sensorial) blockade distributions (T2-T6) were tested bilaterally between T2 and T6 dermatomal levels on the midclavicular line in every 5 minutes through the first 30 minutes after TPVB performances, by using the pin-prick test, and then they were given standard general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. The NRS pain scores (0: no pain and 10: worst pain imaginable), and the dermatomal blockade distribution/numbers of blocked dermatomes of all patients on both sides were asked and documented on postoperative 0th min, 1st, 2nd, 6th, 12th, 24th and 48th hours. Postoperatively, patients in both groups received IV paracetamol 1 g when NRS pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain score at 12th hour. The secondary endpoints included the NRS pain scores and the dermatomal blockade distribution/numbers of blocked dermatomes through the postoperative first 48 hours, block application times, number of patients experienced hypotension or required fentanyl intraoperatively, length of stay in postoperative care unit (PACU), postoperative time until first pain (NRS≥4), the total numbers of paracetamol and tramadol requirements, incidence of postoperative nausea and vomiting (PONV) and duration of sleep on postoperative days 1 and 2, patient and surgeon satisfaction scores.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients undergoing reduction mammaplasty, received single or double injection bilateral thoracic paravertebral block (TPVB) for postoperative analgesia

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

* All TPVB procedures were performed by the same 3 senior anesthesiology residents, always under the supervision of 2 attending anesthesiologists (1 senior resident with 1 attending anesthesiologist at a time)
* Preoperatively, the anesthesiologists who were blinded to the group of that specific patient evaluated the sensorial blockade of dermatomes separately on both sides
* Postoperatively, different anesthesiologists who did not participate in the TPVB performance process of that specific patient and were totally blinded to the group again collected the data.
* Surgeons were also blinded.

Study Groups

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Group S (single injection TPVB group)

Patients received bilateral single injection ultrasound-guided TPVB at the level of T3-T4 with 20 mL bupivacaine 0.375% per injection/side.

Group Type ACTIVE_COMPARATOR

Thoracic paravertebral block-single injection

Intervention Type PROCEDURE

The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).

Group D (double injection TPVB group)

Patients received bilateral double injection ultrasound-guided TPVB at the level of T2-T3 and T4-T5 with 10 mL bupivacaine 0.375% per injection (20 mL bupivacaine 0.375% per side as the single injection group).

Group Type ACTIVE_COMPARATOR

Thoracic paravertebral block-double injection

Intervention Type PROCEDURE

The blocks were performed at both T2-T3 and T4-T5 levels bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).

Interventions

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Thoracic paravertebral block-single injection

The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).

Intervention Type PROCEDURE

Thoracic paravertebral block-double injection

The blocks were performed at both T2-T3 and T4-T5 levels bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) physical status of 1-3
* Capable of consenting
* Capable of understanding the instructions for using the NRS pain scores
* Capable of replying the study-based questions
* Lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
* Absence of mental/psychiatric disorders
* Absence of chronic analgesic/opioid use
* Absence of alcohol/illicit drug use

Exclusion Criteria

* Patient refusal
* American Society of Anesthesiologists (ASA) physical status of 4
* Not capable of consenting
* Not capable of understanding the instructions for using the NRS pain scores
* Not capable of replying the study-based questions
* Contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
* Presence of mental/psychiatric disorders
* Presence of chronic analgesic/opioid use
* Presence of alcohol/illicit drug use

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes