Erector Spinae Plane Block in Scoliotic Adolescents

NCT03968146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-12-03

No results posted yet for this study

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

Interventions

PROCEDURE

Erector Spinae Plane Block

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.

DRUG

Fentanyl

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).

DRUG

additional Fentanyl

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

DRUG

Morphine

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

DRUG

rescue Morphine

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.

DRUG

pethidine

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

DRUG

Ketorolac

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

DRUG

Acetaminophen

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

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2019-11-05
Completion
2019-12-02

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968146 on ClinicalTrials.gov