Erector Spinae Plane Block in Scoliotic Adolescents

NCT03968146 | Completed Phase 2

• 1 other identifier: N-15-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach for perioperative pain management with decreasing the opioids requirement, improving recovery and decreasing ICU stay.

Conditions

Scoliosis Idiopathic; Scoliosis; Adolescence; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.

  the first 24 hours post-operative period.

Secondary Outcomes (2)

• Total fentanyl consumption

  intraoperative period

• Visual Analogue Scale

  the first 24 hours post-operative period.

Study Arms (2)

Group E

ACTIVE COMPARATOR

patients will receive Erector Spinae plane block in addition to intravenous fentanyl

Procedure: Erector Spinae Plane Block; Drug: Fentanyl; Drug: rescue Morphine; Drug: pethidine; Drug: Ketorolac; Drug: Acetaminophen

Group C

OTHER

Control group will receive only intravenous fentanyl.

Drug: Fentanyl; Drug: additional Fentanyl; Drug: Morphine; Drug: rescue Morphine; Drug: pethidine; Drug: Ketorolac; Drug: Acetaminophen

Interventions

Erector Spinae Plane Block PROCEDURE

The linear multi-frequency 6-13 megahertz transducer will be used. In the prone position,under aseptic conditions, the probe will be placed in a longitudinal position 2-3 cm lateral to the vertebral column. The transverse processes of the vertebrae at (mid) level of surgery, the Erector Spinae muscle and the psoas muscle are identified. A 22 gauge echogenic needle will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, A test dose of 5% dextrose in water can expand the fascial plane and confirm needle-tip location prior to injection of local anaesthetic. Then, 0.5 ml/kg of bupivacaine 0.25% with 0.1 mg/kg dexamethasone and adrenaline 1 : 200000 will be injected between erector spinea muscle and transverse process, taking in consideration not exceeding the toxic dose of bupivacaine; 4 mg/kg . the same procedure will be repeated on the contralateral side.

Group E

Fentanyl DRUG

patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).

Also known as: fentanyl for induction and maintenance

Group C; Group E

additional Fentanyl DRUG

patients will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision.

Group C

Morphine DRUG

After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.

Also known as: morphine infusion

Group C

rescue Morphine DRUG

Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if VAS pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr.

Group C; Group E

pethidine DRUG

After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg.

Group C; Group E

Ketorolac DRUG

patients will receive IV ketorolac from the postoperative second day 15 mg q 6 hours, not to exceed 5 days.

Group C; Group E

Acetaminophen DRUG

patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours

Group C; Group E

Eligibility Criteria

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

You may qualify if:

• American society of Anesthesia classification (ASA) I-II
• Patients undergoing dorsal spine instrumentation for scoliosis.

You may not qualify if:

• Refusal of block.
• Bleeding tendency with prothrombin concentration PC less than 75 % or platelet count less than 150,000/µL.
• Skin lesion, wounds or infection at the puncture site.
• Known allergy to local anaesthetic drugs.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Fentanyl; Neoadjuvant Therapy; Maintenance; Morphine; Meperidine; Ketorolac; Acetaminophen

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Health Care Facilities Workforce and Services; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anethesia demonstrator

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: June 18, 2019
• Primary Completion: November 5, 2019
• Study Completion: December 2, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Locations

EG (1)