Single and Double Injection Bilateral Thoracic Paravertebral Blocks in Reduction Mammaplasty

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517331
• Other study ID #: 2016/1282
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• 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).
• 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).

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View 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 — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (Numeric rating scale (NRS)) score	NRS pain score (0: no pain, 10: worst pain imaginable) on postoperative 12th hour	12th hour
Secondary	Pain (Numeric rating scale (NRS)) score	NRS pain scores (0: no pain, 10: worst pain imaginable) on postoperative 0th min, 1st, 2nd, 6th, 24th and 48th hours on both sides	0-48 hours
Secondary	Dermatomal blockade distribution/numbers of blocked dermatomes	Preoperatively, the sensorial blockade was tested bilaterally between the T2 and T6 dermatomal levels (4 regions) on the midclavicular line of the patients in every 5 min through the first 30 min after TPVB performances, by using the pin-prick test. Sensations: "normal", "decreased sensation" or "total anesthesia" separately on both sides. The answers such as "decreased sensation" or "total anesthesia" in different dermatomal regions within T2-T6 were accepted as "successfully blocked dermatome", and the numbers of blocked dermatomes out of 4 dermatomal regions were noted for the right and the left sides.	0-30 minutes
Secondary	Dermatomal blockade distribution/numbers of blocked dermatomes	Postoperatively, the sensorial blockade was tested bilaterally between the T2 and T6 dermatomal levels (4 regions) on the midclavicular line of the patients on postoperative 0th min, 1st, 2nd, 6th, 12th, 24th and 48th hours, by using the pin-prick test. Sensations: "normal", "decreased sensation" or "total anesthesia" separately on both sides. The answers such as "decreased sensation" or "total anesthesia" in different dermatomal regions within T2-T6 were accepted as "successfully blocked dermatome", and the numbers of blocked dermatomes out of 4 dermatomal regions were noted for the right and the left sides.	0-48 hours
Secondary	Block application time	The bilateral TPVB application time was defined as the time period between the needle insertion at the first determined level and the needle withdrawal from the last determined level.	2-20 minutes
Secondary	Number of patients experienced hypotension intraoperatively	The mean arterial pressure (MAP) decreased >20% below preinduction value	Intraoperative 2-4 hours
Secondary	Number of patients required fentanyl intraoperatively	If a = 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 µg/kg) was applied intravenously.	Intraoperative 2-4 hours
Secondary	Length of stay in postoanesthesia care unit (PACU)	Discharge from PACU was determined using the White Fast tracking score =12, whereas none of the parameters was <1 in any category	0-1 hours
Secondary	Postoperative time until first pain	Postoperative first pain description (NRS =4)	0-48 hours
Secondary	Paracetamol consumption/the total numbers of paracetamol requirements	Paracetamol was used when postoperative pain NRS =4 in the postanesthesia care unit or on the wards (on postoperative days 1 and 2)	0-48 hours
Secondary	Tramadol consumption/the total numbers of tramadol requirements	Tramadol was used when postoperative pain NRS =4 again after 1 h of paracetamol application in the postanesthesia care unit or on the wards (on postoperative days 1 and 2)	0-48 hours
Secondary	Incidence of postoperative nausea and vomiting (PONV)	Number of feeling nausea or vomiting (on postoperative days 1 and 2)	0-48 hours
Secondary	Duration of sleep	Total hours of sleep per day (on postoperative days 1 and 2)	0-48 hours
Secondary	Patient satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	0-48 hours
Secondary	Surgeon satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	0-48 hours