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Kyphoscoliosis Surgery: Blood Conservation and Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03319563
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Alaa Mazy, Mansoura University

Brief Summary:
Since the first spinal fusion by Hibbs 1911, yet anesthesia for correction of scoliosis is challenging due to frequently associated co-morbidities, the extensive nature of surgery and liability for many complications. Among the major concerns for anesthesiologists are the pain and bleeding. Scoliosis correction accounts for massive blood loss that may exceed more than half of blood volume. There are many strategies for blood conservation; however sometimes some of them may not be suitable. For analgesia, the most frequently loco regional analgesic techniques in spine surgery are intrathecal, epidural or local infiltration techniques. infiltration data reviled inconclusive and heterogeneous results. Our purpose is to optimize blood conservation and analgesia through anatomically based modification of the infiltration technique.

Condition or disease Intervention/treatment Phase
Posterior Spine Surgery Drug: Local anesthetic-epinephrine Drug: Saline Not Applicable

Detailed Description:
The most frequently loco-regional analgesic techniques in scoliosis surgery are intrathecal, epidural, caudal morphine, or local infiltrations techniques including ultrasound guided thoracolumbar interfascial plane block. however these techniques possess some limitations in scoliosis surgery. Local anesthetic infiltration was first applied over 35 years ago in lumbar spine surgery as a reliable technique for pain relief. However meta-analysis of data reviled inconclusive and heterogeneous efficacy results.This conflict arise from the differences in the technique and drugs.There are three levels of infiltration; subcutaneous, muscular and perineural. Its timing either pre-incision or post-surgery. Generally the preemptive and deep infiltration offer better analgesia when compared with post-surgical and superficial forms. Different drugs including local anesthetics, epinephrine and adjuvants can be given as a single injection or infusion. Doses and volumes are also different, usually ranging from 10 to 30 ml at a concentration of 0.25% Bupivacaine. the use of epinephrine helps bleeding control Concomitantly, unlike the other techniques, bupivacaine infiltration was combined at three levels in this study; subcutaneous, muscular and neural paravertebral to provide sensory, motor and sympathetic blockade all together. In addition, this drug combination may help to maintain spinal cord perfusion by avoiding deliberate hypotension. The high volume sufficient for proper tissue infiltration combined at three anatomically guided levels for three types of nerves has not been described so far. This research may benefit all spine surgery patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : October 10, 2017


Arm Intervention/treatment
Experimental: local anesthetic-epinephrine group

after general anesthesia, the Infiltration cocktail was done by the surgeon at three levels:

  1. Subcutaneous: before incision at a volume 20 ml/10 cm/side.
  2. Muscular Paravertebral: before opening the thoracolumbar fascia, using the same previous volume.
  3. Neural paravertebral: after exposure of the transverse processes. A volume of 5 ml/per each process of the same cocktail, 1 cm deep to the surface of the corresponding process before pedicular screws fixation after negative blood aspiration.
Drug: Local anesthetic-epinephrine
  • Bupivacaine 0.5% (Astra Zeneca) 2 mg/Kg.
  • Lidocaine 5 mg/Kg.
  • Epinephrine 5 mcg/ml of the total volume.
  • Add normal saline to a total volume of 100 ml/10 cm of the wound length.
Other Name: infiltration group

Placebo Comparator: saline group
after general anesthesia, the same infiltration volume and technique using normal saline.
Drug: Saline
normal saline 100 ml/10 cm of the wound length
Other Name: control group




Primary Outcome Measures :
  1. Estimated blood loss [ Time Frame: Intraoperative ]
    milliliter

  2. Total Morphine consumption. [ Time Frame: during first 24 hours postoperatively. ]
    milligram


Secondary Outcome Measures :
  1. The surgical field visualization for subcutaneous incision [ Time Frame: Intraoperative, 10 minutes after skin incision. ]
    measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,

  2. The surgical field visualization for muscular dissection [ Time Frame: Intraoperative, 30 minutes after the thoracolumbar fascia incision, ]
    measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,

  3. The surgical field visualization for nails insertion [ Time Frame: Intraoperative, 30 minutes after the first nail insertion. ]
    measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,

  4. The surgical field visualization for osteotomy [ Time Frame: Intraoperative, 20 minutes after the first osteotomy ]
    measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,

  5. The operative duration [ Time Frame: Intraoperative ]
    minutes, from the start of anesthesia induction to extubation times

  6. The number of blood transfusion unites. [ Time Frame: intraoperative ]
    unites of packed red blood cells

  7. Nitroglycerin consumption [ Time Frame: Intraoperative ]
    milligram

  8. Fentanyl consumption [ Time Frame: intraoperative ]
    microgram

  9. Atracurium consumption [ Time Frame: intraoperative ]
    milligram

  10. Propranolol consumption [ Time Frame: intraoperative ]
    milligram

  11. Mean blood pressure (MBP) [ Time Frame: basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia. ]
    millimeter mercury

  12. Mean heart rate (HR) [ Time Frame: basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia. ]
    beats per minute

  13. Inhalational isoflurane concentration [ Time Frame: intraoperative: at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia induction. ]
    percent

  14. The number of hypertensive episodes [ Time Frame: intraoperative ]
    defined as more than 25% rise of MBP than the basal, provided as total number

  15. The number of tachycardic episodes [ Time Frame: intraoperative ]
    defined as more than 25% rise of HR than the basal, provided as total number

  16. Ephedrine consumption [ Time Frame: intraoperative ]
    milligram

  17. The total amount of fluid utilization. [ Time Frame: intraoperative ]
    milliliter

  18. Visual analog score [ Time Frame: postoperative at 1,4,8,12,16, 20, 24 hours ]
    scale (0-10), 0= no pain

  19. the time to first analgesic request [ Time Frame: postoperative for 24 hours ]
    minutes

  20. Opioid request episodes [ Time Frame: postoperative for 24 hours ]
    number

  21. Ambulation time [ Time Frame: postoperative, the first test after 12 hours, then every 8 hours, up to 72 hours. ]
    hours to the time of first standing alone after the operation.

  22. Hospital stay [ Time Frame: postoperative, till the time of signed discharge order. up to 10 days ]
    days until the discharge time with the ability to walk, eat, controlled pain.

  23. the Incidence of wound complications. [ Time Frame: postoperative till 2 weeks ]
    infection, dehiscence, seroma, hematoma, bleeding

  24. Surgeon satisfaction with the operative filed [ Time Frame: within 2 hours from the end of operation ]
    score (0-10), 10 is the best

  25. Patient satisfaction with analgesia [ Time Frame: 24 hours after the end of surgery ]
    score (0-10), 10 is the best

  26. Urine output [ Time Frame: intraoperative ]
    milliliter



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Kyphoscoliosis patients subjected for spinal correction.
  2. Age 8-18 years.
  3. American Society of Anesthesiologists I-II status.

Exclusion Criteria:

  1. Patient or parents refusal.
  2. Infection at surgical site.
  3. Hypersensitivity to amide local anesthetics.
  4. Coagulopathy.
  5. Blood diseases as sickle cell anemia, hemophilia, idiopathic thrombocytopenic purpura.
  6. Sever cardiac, respiratory, renal or hepatic impairment.
  7. Presence of communication barrier.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319563


Locations
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Egypt
Mansoura University Hospital and Delta Hospital
Mansourah, Dakahlya, Egypt, 35516
Sponsors and Collaborators
Mansoura University
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Responsible Party: Alaa Mazy, Associate professor of anesthesia and surgical intensive care, Mansoura University
ClinicalTrials.gov Identifier: NCT03319563    
Other Study ID Numbers: R/17.02.85
PACTR201703002123104 ( Registry Identifier: the Pan African Clinical Trial Registry )
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: no limits
Access Criteria: e mail: alaa_mazy@yahoo.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epinephrine
Anesthetics
Anesthetics, Local
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Central Nervous System Depressants
Sensory System Agents