Kyphoscoliosis Surgery: Blood Conservation and Analgesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Posterior Spine Surgery

Intervention / Treatment
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* Drug: Local anesthetic-epinephrine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local anesthetic-epinephrine group<br>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<br>* 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.<br>* Other names: infiltration group;|
| Placebo Comparator: saline group<br>after general anesthesia, the same infiltration volume and technique using normal saline. | Drug: Saline<br>* normal saline 100 ml/10 cm of the wound length<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated blood loss | milliliter | Intraoperative | 
| Total Morphine consumption. | milligram | during first 24 hours postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The surgical field visualization for subcutaneous 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, | Intraoperative, 10 minutes after skin incision. | 
| The surgical field visualization for muscular dissection | 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, | Intraoperative, 30 minutes after the thoracolumbar fascia incision, | 
| The surgical field visualization for nails 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, | Intraoperative, 30 minutes after the first nail insertion. | 
| The surgical field visualization for 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, | Intraoperative, 20 minutes after the first osteotomy | 
| The operative duration | minutes, from the start of anesthesia induction to extubation times | Intraoperative | 
| The number of blood transfusion unites. | unites of packed red blood cells | intraoperative | 
| Nitroglycerin consumption | milligram | Intraoperative | 
| Fentanyl consumption | microgram | intraoperative | 
| Atracurium consumption | milligram | intraoperative | 
| Propranolol consumption | milligram | intraoperative | 
| Mean blood pressure (MBP) | millimeter mercury | 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. | 
| Mean heart rate (HR) | beats per minute | 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. | 
| Inhalational isoflurane concentration | percent | intraoperative: at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia induction. | 
| The number of hypertensive episodes | defined as more than 25% rise of MBP than the basal, provided as total number | intraoperative | 
| The number of tachycardic episodes | defined as more than 25% rise of HR than the basal, provided as total number | intraoperative | 
| Ephedrine consumption | milligram | intraoperative | 
| The total amount of fluid utilization. | milliliter | intraoperative | 
| Visual analog score | scale (0-10), 0= no pain | postoperative at 1,4,8,12,16, 20, 24 hours | 
| the time to first analgesic request | minutes | postoperative for 24 hours | 
| Opioid request episodes | number | postoperative for 24 hours | 
| Ambulation time | hours to the time of first standing alone after the operation. | postoperative, the first test after 12 hours, then every 8 hours, up to 72 hours. | 
| Hospital stay | days until the discharge time with the ability to walk, eat, controlled pain. | postoperative, till the time of signed discharge order. up to 10 days | 
| the Incidence of wound complications. | infection, dehiscence, seroma, hematoma, bleeding | postoperative till 2 weeks | 
| Surgeon satisfaction with the operative filed | score (0-10), 10 is the best | within 2 hours from the end of operation | 
| Patient satisfaction with analgesia | score (0-10), 10 is the best | 24 hours after the end of surgery | 
| Urine output | milliliter | intraoperative |