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NCT Number: NCT03319563

Kyphoscoliosis Surgery: Blood Conservation and Analgesia

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.

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Key information

Conditions

Posterior Spine Surgery

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital and Delta Hospital

Al Mansurah, Dakahlya, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Local anesthetic-epinephrine

Drug
  • 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 names: infiltration group

Saline

Drug

normal saline 100 ml/10 cm of the wound length

Other names: control group

Primary outcomes

  1. Estimated blood loss

    Time frame: Intraoperative

    milliliter

  2. Total Morphine consumption.

    Time frame: during first 24 hours postoperatively.

    milligram

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2017
Registry last updated
Oct 26, 2020

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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