Thoracic Spinal Anesthesia in Awake Breast Surgery

NCT ID: NCT03319511

Last Updated: 2017-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-24
• Study Completion Date: 2016-11-12

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.

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.

Conditions

Breast Cancer

Keywords

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

Study Design

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

Study Groups

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

Group Type: ACTIVE_COMPARATOR

paravertebral group

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

spinal group

Intervention Type: OTHER

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

Interventions

spinal group

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

STSB; TPVB

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alaa Mazy

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mazy

Associate professor of anesthesia and surgical intensive care

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oncolgy Center, Mansoura University,

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MD/15.05.91

Identifier Type: -

Identifier Source: org_study_id