Thoracic Spinal Anesthesia in Awake Breast Surgery

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319511
• Other study ID #: MD/15.05.91
• Status: Completed
• Phase: N/A
• First received: October 16, 2017
• Last updated: October 19, 2017
• Start date: November 24, 2014
• Est. completion date: November 12, 2016

Study information

• Verified date: October 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 12, 2016
• Est. primary completion date: November 12, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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 a 2 adrenergic agonist local anesthetic drugs.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• spinal group
plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 µg. once injection.
• 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.

Locations

Country	Name	City	State
Egypt	Oncolgy Center, Mansoura University,	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Mazy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the block success rate.	in number, defined as complete sensory block in all dermatomes (T1-T6 ).	within 30 min of injection
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Total ephedrine consumption	milligram, Hypotension defined as 20% drop in baseline blood pressure or systolic pressure below 90 mm Hg)	intraoperative
Secondary	Total atropine consumption	milligram, Bradycardia defined as heart rate below 50 beat/minute	intraoperative
Secondary	Total Midazolam consumption	milligram,	intraoperative
Secondary	Hypotension episodes	in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg).	Intraoperative and postoperative for 24 hours.
Secondary	Bradycardia episodes	In number. Bradycardia defined as heart rate below 50 beat/minute	Intraoperative and postoperative for 24 hours.
Secondary	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.
Secondary	incidence of nausea	In number.	Intraoperative and postoperative for 24 hours.
Secondary	incidence of vomiting	In number.	Intraoperative and postoperative for 24 hours.
Secondary	the incidence of pneumothorax.	in numbers. confirmed by plane X-ray	intraoperative and postoperative for 6 hours.
Secondary	The incidence of post-dural puncture headache.	in numbers.	postoperative for 72 hours.
Secondary	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.
Secondary	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.
Secondary	The total mepridine consumption.	milligram	postoperative for 24 hours.
Secondary	satisfaction of the patient	scale from 0-10, 10= the highest.	after 24 hours from the end of operation.
Secondary	satisfaction of the surgeon	scale from 0-10, 10= the highest.	within 2 hours from the end of operation.