Kyphoscoliosis Surgery: Blood Conservation and Analgesia

• ClinicalTrials.gov Identifier: NCT03319563
• Recruitment Status: Completed
• First Posted: October 24, 2017
• Last Update Posted: October 26, 2020
• Sponsor: Mansoura University
• Information provided by (Responsible Party): Alaa Mazy Mazy, Mansoura University

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: local anesthetic-epinephrine group; after general anesthesia, the Infiltration cocktail was done by the surgeon at three levels: Subcutaneous: before incision at a volume 20 ml/10 cm/side.; Muscular Paravertebral: before opening the thoracolumbar fascia, using the same previous volume.; 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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Egypt

Mansoura University Hospital and Delta Hospital

Mansourah, Dakahlya, Egypt, 35516

Sponsors and Collaborators

Mansoura University

More Information

• Responsible Party: Alaa Mazy 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
• Last Update Posted: October 26, 2020
• Last Verified: October 2020

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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