Kyphoscoliosis Surgery: Blood Conservation and Analgesia

Not Applicable

Completed

• Conditions: Posterior Spine Surgery
• Interventions: Drug: Saline; Drug: Local anesthetic-epinephrine

• Registration Number: NCT03319563
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2017-04-11
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline group	Saline	after general anesthesia, the same infiltration volume and technique using normal saline.
local anesthetic-epinephrine group	Local anesthetic-epinephrine	after general anesthesia, the Infiltration cocktail was done by the surgeon at three levels: 1. Subcutaneous: before incision at a volume 20 ml/10 cm/side. 2. Muscular Paravertebral: before opening the thoracolumbar fascia, using the same previous volume. 3. 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.

Primary Outcome Measures

Name	Time	Method
Estimated blood loss	Intraoperative	milliliter
Total Morphine consumption.	during first 24 hours postoperatively.	milligram

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University Hospital and Delta Hospital; 🇪🇬 Mansourah, Dakahlya, Egypt