Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks

Anesthesia Clinical Trial

Official title:

Randomized Prospective Study to Evaluate Efficacy and Safety of Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks for Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852421
• Other study ID #: 17477
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: August 15, 2016
• Start date: August 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast surgeries resulting in reduced narcotic consumption, reduced nausea, improved quality of recovery, reduced chronic pain and possibly reduced metastasis with breast cancer. Traditionally, PVB is done by multiple injections below T1-T5 transverse processes. With multiple injections, the risk is increased for a pleural, an intraneural, and/or an intravascular injection. Recently, ultrasonography is being used to facilitate PVB. The use of ultrasound imaging enables real-time needle visualization during the procedure. This may improve efficacy and reduce the chances of complication like pneumothorax. Currently, there are no data comparing ultrasound-guided single injection technique with multiple injections technique with regards to extent of spread for PVB. Our objective is to investigate the extent of dermatomal spread of PVB when equal volumes of local anesthetic are injected at one versus five paravertebral sites for patients undergoing major breast surgery. In addition, the investigators wish to compare the performance time and duration of analgesia.

Methodology: After local REB approval, 72 patients undergoing a unilateral mastectomy with or without axillary node dissection will be randomized to receive either single or multiple injections PVB. The PVB will be performed in prone position under real-time ultrasound guidance using a para-sagittal approach.The patients in single injection group will receive single injection PVB at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham injections. Patients in the multiple injection group will receive five injections of PVB from T1 to T5 level. 5 ml of 0.5% ropivacaine will be injected at each level. Pleural drift will be used as a sign of correct needle tip location and local anaesthetic spread. The pinprick method will be used to assess the extent of dermatomal blockade, 20 minutes following the completion of procedure. All patients will receive a standardized general anesthesia for the surgery. Any adverse events including pneumothorax, epidural spread, LA toxicity/seizure, total spinal, will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Females, age 18 to 80 years, scheduled to receive unilateral mastectomy surgery, with or without axillary node dissection

• Able to give informed consent

• Able to cooperate with study process

• Availability of home telephone.

Exclusion Criteria:

• Patient refusal or lack of informed consent

• allergy to local anesthetic and other medications used in the study

• Bilateral mastectomies

• Coexisting hematological disorder or with deranged coagulation parameters

• Pre-existing major organ dysfunction such as hepatic and renal failure

• Significant thoracic kyphoscoliosis

• History of previous thoracic surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Breast Neoplasms

Intervention

Procedure:
• Single injection paravertebral block
The patients in single injection group will receive single injection paravertebral block at T3-T4 level with 25 ml of 0.5% "ropivacaine" and four subcutaneous sham injections
• Multiple injection paravertebral blocks
Patients in the multiple injection group will receive five injections of paravertebral blocks from T1 to T5 level. 5 ml of 0.5% "ropivacaine" was injected at each level.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre University Hospital	London	Ontario
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Boughey JC, Goravanchi F, Parris RN, Kee SS, Frenzel JC, Hunt KK, Ames FC, Kuerer HM, Lucci A. Improved postoperative pain control using thoracic paravertebral block for breast operations. Breast J. 2009 Sep-Oct;15(5):483-8. doi: 10.1111/j.1524-4741.2009.00763.x. Epub 2009 Jul 13. — View Citation

Cheema S, Richardson J, McGurgan P. Factors affecting the spread of bupivacaine in the adult thoracic paravertebral space. Anaesthesia. 2003 Jul;58(7):684-7. — View Citation

Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4. — View Citation

Lönnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. — View Citation

Naja ZM, El-Rajab M, Al-Tannir MA, Ziade FM, Tayara K, Younes F, Lönnqvist PA. Thoracic paravertebral block: influence of the number of injections. Reg Anesth Pain Med. 2006 May-Jun;31(3):196-201. — View Citation

O Riain SC, Donnell BO, Cuffe T, Harmon DC, Fraher JP, Shorten G. Thoracic paravertebral block using real-time ultrasound guidance. Anesth Analg. 2010 Jan 1;110(1):248-51. doi: 10.1213/ANE.0b013e3181c35906. Epub 2009 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory dermatomal spread	20 minutes after block performance	20 minutes	No
Secondary	Time to performance of procedure		Duration of procedure	No
Secondary	Cephalic and caudal dermatomal spread		20 minutes after block performance	No
Secondary	Incidence of complication	Follow-up phone call	24 hours	Yes
Secondary	VAS pain scores in PACU	During PACU stay	6 hours	No
Secondary	Duration of self-reported numbness at the surgical site	At follow-up phone call	24 hours	No