Clinical trial NCT04517331: Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty
Official title: Comparison of Single and Double Injection Ultrasound-Guided Bilateral Thoracic Paravertebral Block Effects in Patients Undergoing Reduction Mammaplasty: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Thoracic paravertebral blocks
Postoperative analgesia, numeric rating scale
Dermatomal blockade distribution
Postoperative time until first pain
Analgesic consumption
Reduction mammaplasty
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing reduction mammaplasty, received single or double injection bilateral thoracic paravertebral block (TPVB) for postoperative analgesia
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain (Numeric rating scale (NRS)) score
timeFrame: 12th hour
Secondary outcomes:
measure: Pain (Numeric rating scale (NRS)) score
timeFrame: 0-48 hours
measure: Dermatomal blockade distribution/numbers of blocked dermatomes
timeFrame: 0-30 minutes
measure: Dermatomal blockade distribution/numbers of blocked dermatomes
timeFrame: 0-48 hours
measure: Block application time
timeFrame: 2-20 minutes
measure: Number of patients experienced hypotension intraoperatively
timeFrame: Intraoperative 2-4 hours
measure: Number of patients required fentanyl intraoperatively
timeFrame: Intraoperative 2-4 hours
measure: Length of stay in postoanesthesia care unit (PACU)
timeFrame: 0-1 hours
measure: Postoperative time until first pain
timeFrame: 0-48 hours
measure: Paracetamol consumption/the total numbers of paracetamol requirements
timeFrame: 0-48 hours
measure: Tramadol consumption/the total numbers of tramadol requirements
timeFrame: 0-48 hours
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: 0-48 hours
measure: Duration of sleep
timeFrame: 0-48 hours
measure: Patient satisfaction
timeFrame: 0-48 hours
measure: Surgeon satisfaction
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
affiliation: Study Principal Investigator, Corresponding author
name: Emine A Salviz, MD,AssocProf
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.