Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks

NCT ID: NCT02852421

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-05-31

Brief 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.

Conditions

Breast Neoplasms; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multiple injection paravertebral blocks

Patients in this group will receive five injections of paravertebral blocks from T1 to T5 level. 5 ml of 0.5% "ropivacaine" was injected at each level.

Group Type: ACTIVE_COMPARATOR

Multiple injection paravertebral blocks

Intervention Type: PROCEDURE

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.

Single injection paravertebral block

Patients in single injection group will receive single injection paravertebral blocks at T3-T4 level with 25 ml of 0.5% "ropivacaine" and four subcutaneous sham injections.

Group Type: EXPERIMENTAL

Single injection paravertebral block

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Sugantha Ganapathy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Joseph's Health Care

London, Ontario, Canada

London Health Sciences Centre University Hospital

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 19624418 (View on PubMed)

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. doi: 10.1097/00000542-200610000-00008.

Reference Type: BACKGROUND

PMID: 17006061 (View on PubMed)

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. doi: 10.1046/j.1365-2044.2003.03189_1.x.

Reference Type: BACKGROUND

PMID: 12886912 (View on PubMed)

Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.

Reference Type: BACKGROUND

PMID: 7573876 (View on PubMed)

Naja ZM, El-Rajab M, Al-Tannir MA, Ziade FM, Tayara K, Younes F, Lonnqvist PA. Thoracic paravertebral block: influence of the number of injections. Reg Anesth Pain Med. 2006 May-Jun;31(3):196-201. doi: 10.1016/j.rapm.2005.12.004.

Reference Type: BACKGROUND

PMID: 16701182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19933536 (View on PubMed)

Uppal V, Sondekoppam RV, Sodhi P, Johnston D, Ganapathy S. Single-Injection Versus Multiple-Injection Technique of Ultrasound-Guided Paravertebral Blocks: A Randomized Controlled Study Comparing Dermatomal Spread. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):575-581. doi: 10.1097/AAP.0000000000000631.

Reference Type: DERIVED

PMID: 28665874 (View on PubMed)

Other Identifiers

17477

Identifier Type: -

Identifier Source: org_study_id