Clinical trial NCT03319563: Kyphoscoliosis Surgery: Blood Conservation and Analgesia
Official title: High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Spine Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 52
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Total Morphine consumption.
timeFrame: during first 24 hours postoperatively.
Secondary outcomes:
measure: The surgical field visualization for subcutaneous incision
timeFrame: Intraoperative, 10 minutes after skin incision.
measure: The surgical field visualization for muscular dissection
timeFrame: Intraoperative, 30 minutes after the thoracolumbar fascia incision,
measure: The surgical field visualization for nails insertion
timeFrame: Intraoperative, 30 minutes after the first nail insertion.
measure: The surgical field visualization for osteotomy
timeFrame: Intraoperative, 20 minutes after the first osteotomy
measure: The operative duration
timeFrame: Intraoperative
measure: The number of blood transfusion unites.
timeFrame: intraoperative
measure: Nitroglycerin consumption
timeFrame: Intraoperative
measure: Fentanyl consumption
timeFrame: intraoperative
measure: Atracurium consumption
timeFrame: intraoperative
measure: Propranolol consumption
timeFrame: intraoperative
measure: Mean blood pressure (MBP)
timeFrame: 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.
measure: Mean heart rate (HR)
timeFrame: 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.
measure: Inhalational isoflurane concentration
timeFrame: intraoperative: at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia induction.
measure: The number of hypertensive episodes
timeFrame: intraoperative
measure: The number of tachycardic episodes
timeFrame: intraoperative
measure: Ephedrine consumption
timeFrame: intraoperative
measure: The total amount of fluid utilization.
timeFrame: intraoperative
measure: Visual analog score
timeFrame: postoperative at 1,4,8,12,16, 20, 24 hours
measure: the time to first analgesic request
timeFrame: postoperative for 24 hours
measure: Opioid request episodes
timeFrame: postoperative for 24 hours
measure: Ambulation time
timeFrame: postoperative, the first test after 12 hours, then every 8 hours, up to 72 hours.
measure: Hospital stay
timeFrame: postoperative, till the time of signed discharge order. up to 10 days
measure: the Incidence of wound complications.
timeFrame: postoperative till 2 weeks
measure: Surgeon satisfaction with the operative filed
timeFrame: within 2 hours from the end of operation
measure: Patient satisfaction with analgesia
timeFrame: 24 hours after the end of surgery
measure: Urine output
timeFrame: intraoperative
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Hospital and Delta Hospital
state: Dakahlya
Study officials:
References: