Kyphoscoliosis Surgery: Blood Conservation and Analgesia

Posterior Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319563
• Other study ID #: R/17.02.85
• Secondary ID: PACTR20170300212
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: October 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posterior Spine Surgery

Intervention

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.
• Saline
normal saline 100 ml/10 cm of the wound length

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital and Delta Hospital	Mansourah	Dakahlya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss	milliliter	Intraoperative
Primary	Total Morphine consumption.	milligram	during first 24 hours postoperatively.
Secondary	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.
Secondary	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,
Secondary	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.
Secondary	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
Secondary	The operative duration	minutes, from the start of anesthesia induction to extubation times	Intraoperative
Secondary	The number of blood transfusion unites.	unites of packed red blood cells	intraoperative
Secondary	Nitroglycerin consumption	milligram	Intraoperative
Secondary	Fentanyl consumption	microgram	intraoperative
Secondary	Atracurium consumption	milligram	intraoperative
Secondary	Propranolol consumption	milligram	intraoperative
Secondary	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.
Secondary	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.
Secondary	Inhalational isoflurane concentration	percent	intraoperative: at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia induction.
Secondary	The number of hypertensive episodes	defined as more than 25% rise of MBP than the basal, provided as total number	intraoperative
Secondary	The number of tachycardic episodes	defined as more than 25% rise of HR than the basal, provided as total number	intraoperative
Secondary	Ephedrine consumption	milligram	intraoperative
Secondary	The total amount of fluid utilization.	milliliter	intraoperative
Secondary	Visual analog score	scale (0-10), 0= no pain	postoperative at 1,4,8,12,16, 20, 24 hours
Secondary	the time to first analgesic request	minutes	postoperative for 24 hours
Secondary	Opioid request episodes	number	postoperative for 24 hours
Secondary	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.
Secondary	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
Secondary	the Incidence of wound complications.	infection, dehiscence, seroma, hematoma, bleeding	postoperative till 2 weeks
Secondary	Surgeon satisfaction with the operative filed	score (0-10), 10 is the best	within 2 hours from the end of operation
Secondary	Patient satisfaction with analgesia	score (0-10), 10 is the best	24 hours after the end of surgery
Secondary	Urine output	milliliter	intraoperative