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Completed

NCT Number: NCT03319511

Thoracic Spinal Anesthesia in Awake Breast 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.

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Key information

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oncolgy Center, Mansoura University,

Al Mansurah, DK, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

spinal group

Other

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

Other names: STSB

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.

Other names: TPVB

Primary outcomes

  1. the block success rate.

    Time frame: within 30 min of injection

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

Secondary outcomes

  1. The paravertebral onset of sensory block

    Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.

    tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.

  2. The spinal onset of sensory block

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

    tested for loss of sensation, with a needle along the anterior axillary line from T1-T6 on the blocked side.

  3. The power of hand grip (T1/ C8)

    Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.

    four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.

  4. The power of wrist flexion (C8/C7)

    Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.

    four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.

  5. The power of elbow flexion (C6/ C5)

    Time frame: 5, 10, 15, 20, 52, 30 minutes after injection.

    four grades (0-3), 0= no motor block, 1= partial, 2= almost complete, 3= complete motor block.

  6. The onset time of lower limb motor block (Bromage 3)

    Time frame: 5, 10, 15, 20, 25, 30 minutes after injection.

    in minutes, 3= unable to move legs or feet.

  7. The duration of lower limb motor block (Bromage 0)

    Time frame: 30, 45, 60, 90,120, 150 minutes after injection.

    minutes, 0= free movement of legs and feet

  8. Ramsey sedation scale

    Time frame: 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.

    (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).

  9. Heart rate

    Time frame: 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.

    beat/minute

  10. Systolic blood pressure

    Time frame: 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.

    millimeter mercury

  11. Mean blood pressure

    Time frame: 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.

    millimeter mercury

  12. Total ephedrine consumption

    Time frame: intraoperative

    milligram, Hypotension defined as 20% drop in baseline blood pressure or systolic pressure below 90 mm Hg)

  13. Total atropine consumption

    Time frame: intraoperative

    milligram, Bradycardia defined as heart rate below 50 beat/minute

  14. Total Midazolam consumption

    Time frame: intraoperative

    milligram,

  15. Hypotension episodes

    Time frame: Intraoperative and postoperative for 24 hours.

    in number. Hypotension (20% drop in baseline blood pressure or systolic pressure below 90 mm Hg).

  16. Bradycardia episodes

    Time frame: Intraoperative and postoperative for 24 hours.

    In number. Bradycardia defined as heart rate below 50 beat/minute

  17. Hypoxia episodes

    Time frame: Intraoperative and postoperative for 24 hours.

    In number. Hypoxia is defined as defined as respiratory rate <10 breath/ minutes or oxygen saturation less than 90%.

  18. incidence of nausea

    Time frame: Intraoperative and postoperative for 24 hours.

    In number.

  19. incidence of vomiting

    Time frame: Intraoperative and postoperative for 24 hours.

    In number.

  20. the incidence of pneumothorax.

    Time frame: intraoperative and postoperative for 6 hours.

    in numbers. confirmed by plane X-ray

  21. The incidence of post-dural puncture headache.

    Time frame: postoperative for 72 hours.

    in numbers.

  22. The duration of upper limb motor block,

    Time frame: 15, 30, 45, 60, 90 minutes after injection.

    minutes. starting from the time of score 3 to score 0 (0= no motor block).

  23. Visual analog scale

    Time frame: at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.

    a 0-10 cm scale, 0 represents no pain and 10 is the worst pain.

  24. The total mepridine consumption.

    Time frame: postoperative for 24 hours.

    milligram

  25. satisfaction of the patient

    Time frame: after 24 hours from the end of operation.

    scale from 0-10, 10= the highest.

  26. satisfaction of the surgeon

    Time frame: within 2 hours from the end of operation.

    scale from 0-10, 10= the highest.

Sponsors and collaborators

Lead sponsor

Alaa Mazy

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2017
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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