Thoracic Spinal Anesthesia in Awake Breast Surgery

NCT03319511 | Completed DMC

• 1 other identifier: MD/15.05.91
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia is the conventional technique used for breast surgery. breast surgery is associated with a high incidence of postoperative pain, it is estimated that over 50 % of women suffer chronic pain following breast cancer surgery. Regional anesthesia is a good alternative to general anesthesia for breast cancer surgery, providing superior analgesia and fewer side effects related to a standard opiate-based analgesia. there is no evident optimal regional techniques for operative procedures on the breast and axilla, like high thoracic epidural, cervical epidural, paravertebral block, intrerpleural block, PECs block, serratus plane block and segmental thoracic spinal anesthesia. Regional anesthesia decreases operative stress, provides beneficial hemodynamic effects especially for critically ill patients and decreases postoperative morbidity and mortality. Also it reduces post-operative nausea and vomiting and provides prolonged post-operative sensory block, minimizing narcotic requirements. Additionally, this application positively affects the early start of feeding and mobilization.

Conditions

Breast Cancer

Keywords

thoracic spinal; awake mastectomy; paravertebral block; analgesia; ultrasound; breast cancer

Outcome Measures

Primary Outcomes (1)

• the block success rate.

  in number, defined as complete sensory block in all dermatomes (T1-T6 ).

  within 30 min of injection

Secondary Outcomes (26)

• The paravertebral onset of sensory block

  5, 10, 15, 20, 52, 30 minutes after injection.

• The spinal onset of sensory block

  2, 4, 6, 8, 10, 12, 14 minutes after injection.

• The power of hand grip (T1/ C8)

  5, 10, 15, 20, 52, 30 minutes after injection.

• The power of wrist flexion (C8/C7)

  5, 10, 15, 20, 52, 30 minutes after injection.

• The power of elbow flexion (C6/ C5)

  5, 10, 15, 20, 52, 30 minutes after injection.

Study Arms (2)

paravertebral group

ACTIVE COMPARATOR

ultrasound guided, in sitting position, or lateral position, at T2 and T4 levels, using 22 G spinal needle, in plane technique, traversing the costo-transverse ligament

Other: paravertebral group

spinal group

EXPERIMENTAL

Ultrasound guided, In the lateral decubitus or sitting position, the puncture performed via para-median approach, at the T4-T5 or T5-T6 interspace, with a 27G spinal needle. After piercing the ligamentum flavum, the needle's stylet removed and the hub observed for free flow of CSF; injection when there is a flow of clear CSF.

Other: spinal group

Interventions

spinal group OTHER

plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection.

Also known as: STSB

spinal group

paravertebral group OTHER

plain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels.

Also known as: TPVB

paravertebral group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Gender Eligibility Details: female patients scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II, III, IV patients may have:
• Cardiovascular disease (e.g., rheumatic heart, systemic hypertension, ischemic heart)
• Lung disease (e.g., bronchial asthma, COPD)
• Renal disease (e.g., renal failure, polycystic kidney)
• Liver disease (e.g., cirrhosis, hepatitis)
• Endocrine disease (e.g., diabetes mellitus)

You may not qualify if:

• Patient refusal
• Contraindication to regional anesthesia (coagulopathy, local infection),
• Spinal deformities.
• An allergy to α 2 adrenergic agonist local anesthetic drugs.

Sponsors & Collaborators

• Alaa Mazy: lead

Study Sites (1)

Oncolgy Center, Mansoura University,

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: a dorsal thoracic gauze cover.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 24, 2017
• Study Start: November 24, 2014
• Primary Completion: November 12, 2016
• Study Completion: November 12, 2016
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: after publication, for no limit
• Access Criteria: e mail: alaa\ mazy@yahoo.com

Locations

EG (1)