Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty

NCT04517331 | Completed

• 1 other identifier: 2016/1282
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

Thoracic paravertebral blocks; Postoperative analgesia, numeric rating scale; Dermatomal blockade distribution; Postoperative time until first pain; Analgesic consumption; Reduction mammaplasty

Outcome Measures

Primary Outcomes (1)

• Pain (Numeric rating scale (NRS)) score

  NRS pain score (0: no pain, 10: worst pain imaginable) on postoperative 12th hour

  12th hour

Secondary Outcomes (14)

• Pain (Numeric rating scale (NRS)) score

  0-48 hours

• Dermatomal blockade distribution/numbers of blocked dermatomes

  0-30 minutes

• Dermatomal blockade distribution/numbers of blocked dermatomes

  0-48 hours

• Block application time

  2-20 minutes

• Number of patients experienced hypotension intraoperatively

  Intraoperative 2-4 hours

Study Arms (2)

Group S (single injection TPVB group)

ACTIVE COMPARATOR

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

Procedure: Thoracic paravertebral block-single injection

Group D (double injection TPVB group)

ACTIVE COMPARATOR

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).

Procedure: Thoracic paravertebral block-double injection

Interventions

Thoracic paravertebral block-single injection 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 S (single injection TPVB group)

Thoracic paravertebral block-double injection 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).

Group D (double injection TPVB group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (3)

• Salviz EA, Sivrikoz N, Ozonur A, Orhan-Sungur M, Savran-Karadeniz M, Altun D, Hocaoglu E, Celet-Ozden B, Tugrul KM. Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anesthesia in Patients Undergoing Reduction Mammaplasty: A Historical Cohort Study. Plast Reconstr Surg. 2017 Jan;139(1):20e-28e. doi: 10.1097/PRS.0000000000002842.

  PMID: 28027224 RESULT

• Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.

  PMID: 22055006 RESULT

• Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.

  PMID: 17023279 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Emine A Salviz, MD,AssocProf

  Study Principal Investigator, Corresponding author

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 18, 2020
• Study Start: December 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)