Thoracic Spinal Anesthesia in Awake Breast Surgery

Comparison Between Thoracic Para-vertebral Block and Segmental Thoracic Spinal Anesthesia in Breast Cancer Surgery

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: paravertebral group; Other: spinal group

Detailed Description

Thoracic paravertebral block (TPVB) is an alternative method to general anesthesia for patients undergoing breast surgery, because it provides a safe anesthesia with balanced hemodynamic response with unilateral somatic and sympathetic blockade, allows postoperative analgesia lowering narcotic usage , minimal nausea and vomiting rate, early discharge and low cost.

Segmental thoracic spinal anesthesia have introduced for cardiac surgery in adults and children in the early 1990's. Kowalewski et al., performed over 10000 cases of spinal injections without a single case of spinal/epidural hematoma or any neurological complications, also segmental thoracic spinal anesthesia has been used successfully for laparoscopic cholecystectomy and abdominal surgeries. It has some advantages when compared with general anesthesia and can be a sole anesthetic in breast cancer surgery with axillary lymph node clearance especially in critical cases. Among its advantages are the quality of postoperative analgesia, lower incidence of nausea and vomiting, and shorter recovery time, with the consequent early hospital discharge. The dose of the anesthetic is exceedingly low, compared with lumbar spinal anesthesia, given the highly specific block to only certain nerve functions along a section of the cord, there is no blockade of the lower extremities. This means that a significantly larger portion of the body experiences no venal dilation, and may offer a compensatory buffer to adverse changes in blood pressure intra-operatively. there was no recorded of neurological complications.The incidence of parasthesia in a study with 300 patients subjected to thoracic spinal puncture at T10-11 was 4.67% in the cut needle group and 8.67% in the pencil point needle group, similar to that reported in lumbar spinal anesthesia.The aim of the present study is the comparison between two sole regional anesthetic techniques, thoracic para-vertebral block and segmental thoracic spinal anesthesia in breast cancer surgery especially for critically ill patients.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 35516
      • Oncolgy Center, Mansoura University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

ASA II, III, IV patients may have:

1. Cardiovascular disease (e.g., rheumatic heart, systemic hypertension, ischemic heart)
2. Lung disease (e.g., bronchial asthma, COPD)
3. Renal disease (e.g., renal failure, polycystic kidney)
4. Liver disease (e.g., cirrhosis, hepatitis)
5. Endocrine disease (e.g., diabetes mellitus)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: paravertebral group; 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; plain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels.; Other Names: TPVB
Experimental: spinal group; 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; plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection.; Other Names: STSB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the block success rate.	in number, defined as complete sensory block in all dermatomes (T1-T6 ).	within 30 min of injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The paravertebral onset of sensory block	tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.	5, 10, 15, 20, 52, 30 minutes after injection.
The spinal onset of sensory block	tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.	2, 4, 6, 8, 10, 12, 14 minutes after injection.
The power of hand grip (T1/ C8)	four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.	5, 10, 15, 20, 52, 30 minutes after injection.
The power of wrist flexion (C8/C7)	four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.	5, 10, 15, 20, 52, 30 minutes after injection.
The power of elbow flexion (C6/ C5)	four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.	5, 10, 15, 20, 52, 30 minutes after injection.
The onset time of lower limb motor block (Bromage 3)	in minutes, 3= unable to move legs or feet.	5, 10, 15, 20, 25, 30 minutes after injection.
The duration of lower limb motor block (Bromage 0)	minutes, 0= free movement of legs and feet	30, 45, 60, 90,120, 150 minutes after injection.
Ramsey sedation scale	(1 = awake, conscious, no sedation; 2 = calm and compose; 3 = awake on verbal command; 4 = brisk response to gentle tactile stimulation; 5 = awake on vigorous shaking; 6 = unarousable).	0 (basal), then1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Heart rate	beat/minute	0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Systolic blood pressure	millimeter mercury	0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Mean blood pressure	millimeter mercury	0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.
Total ephedrine consumption	milligram, Hypotension defined as 20% drop in baseline blood pressure or systolic pressure below 90 mm Hg)	intraoperative
Total atropine consumption	milligram, Bradycardia defined as heart rate below 50 beat/minute	intraoperative
Total Midazolam consumption	milligram,	intraoperative
Hypotension episodes	in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg).	Intraoperative and postoperative for 24 hours.
Bradycardia episodes	In number. Bradycardia defined as heart rate below 50 beat/minute	Intraoperative and postoperative for 24 hours.
Hypoxia episodes	In number. Hypoxia is defined as defined as respiratory rate <10 breath/ minutes or oxygen saturation less than 90%.	Intraoperative and postoperative for 24 hours.
incidence of nausea	In number.	Intraoperative and postoperative for 24 hours.
incidence of vomiting	In number.	Intraoperative and postoperative for 24 hours.
the incidence of pneumothorax.	in numbers. confirmed by plane X-ray	intraoperative and postoperative for 6 hours.
The incidence of post-dural puncture headache.	in numbers.	postoperative for 72 hours.
The duration of upper limb motor block,	minutes. starting from the time of score 3 to score 0 (0= no motor block).	15, 30, 45, 60, 90 minutes after injection.
Visual analog scale	a 0-10 cm scale, 0 represents no pain and 10 is the worst pain.	at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.
The total mepridine consumption.	milligram	postoperative for 24 hours.
satisfaction of the patient	scale from 0-10, 10= the highest.	after 24 hours from the end of operation.
satisfaction of the surgeon	scale from 0-10, 10= the highest.	within 2 hours from the end of operation.

Collaborators and Investigators

• Sponsor: Alaa Mazy

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2014
• Primary Completion (Actual): November 12, 2016
• Study Completion (Actual): November 12, 2016

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer; ultrasound; analgesia; paravertebral block; thoracic spinal; awake mastectomy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MD/15.05.91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: after publication, for no limit
• IPD Sharing Access Criteria: e mail: alaa_mazy@yahoo.com
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No