Kyphoscoliosis Surgery: Blood Conservation and Analgesia

NCT03319563 | Completed DMC

• 2 other identifiers: R/17.02.85PACTR201703002123104
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Spine Surgery

Outcome Measures

Primary Outcomes (2)

• Estimated blood loss

  milliliter

  Intraoperative

• Total Morphine consumption.

  milligram

  during first 24 hours postoperatively.

Secondary Outcomes (26)

• The surgical field visualization for subcutaneous incision

  Intraoperative, 10 minutes after skin incision.

• The surgical field visualization for muscular dissection

  Intraoperative, 30 minutes after the thoracolumbar fascia incision,

• The surgical field visualization for nails insertion

  Intraoperative, 30 minutes after the first nail insertion.

• The surgical field visualization for osteotomy

  Intraoperative, 20 minutes after the first osteotomy

• The operative duration

  Intraoperative

Study Arms (2)

local anesthetic-epinephrine group

EXPERIMENTAL

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.

Drug: Local anesthetic-epinephrine

saline group

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Local anesthetic-epinephrine 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.

Also known as: infiltration group

local anesthetic-epinephrine group

Saline DRUG

normal saline 100 ml/10 cm of the wound length

Also known as: control group

saline group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Kyphoscoliosis patients subjected for spinal correction.
• Age 8-18 years.
• American Society of Anesthesiologists I-II status.

You may not qualify if:

• Patient or parents refusal.
• Infection at surgical site.
• Hypersensitivity to amide local anesthetics.
• Coagulopathy.
• Blood diseases as sickle cell anemia, hemophilia, idiopathic thrombocytopenic purpura.
• Sever cardiac, respiratory, renal or hepatic impairment.
• Presence of communication barrier.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital and Delta Hospital

Al Mansurah, Dakahlya, 35516, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride; Control Groups

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 24, 2017
• Study Start: April 11, 2017
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: no limits
• Access Criteria: e mail: alaa\ mazy@yahoo.com

Locations

EG (1)