Kyphoscoliosis Surgery: Blood Conservation and Analgesia

NCT ID: NCT03319563

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2017-10-10

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.

Conditions

Posterior Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

local anesthetic-epinephrine group

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.

Group Type: EXPERIMENTAL

Local anesthetic-epinephrine

Intervention Type: DRUG

• 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 group

after general anesthesia, the same infiltration volume and technique using normal saline.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

normal saline 100 ml/10 cm of the wound length

Interventions

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.

Intervention Type: DRUG

Saline

normal saline 100 ml/10 cm of the wound length

Intervention Type: DRUG

Other Intervention Names

infiltration group; control group

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mazy Mazy

Associate professor of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University Hospital and Delta Hospital

Al Mansurah, Dakahlya, Egypt

Countries

Egypt

Other Identifiers

PACTR201703002123104

Identifier Type: REGISTRY

Identifier Source: secondary_id

R/17.02.85

Identifier Type: -

Identifier Source: org_study_id