Kyphoscoliosis Surgery: Blood Conservation and Analgesia

High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in 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.

Study Overview

• Status: Completed
• Conditions: Posterior Spine Surgery
• Intervention / Treatment: Drug: Local anesthetic-epinephrine; Drug: Saline

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlya
    • Mansourah, Dakahlya, Egypt, 35516
      • Mansoura University Hospital and Delta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: control group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Anesthetics; Anesthetics, Local; Epinephrine
• Other Study ID Numbers: R/17.02.85; PACTR201703002123104 (Registry Identifier: the Pan African Clinical Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: after publication
• IPD Sharing Time Frame: no limits
• IPD Sharing Access Criteria: e mail: alaa_mazy@yahoo.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No