Erector Spinea Plane Block in Pediatric Hip Surgery

Postoperative Pain Clinical Trial

Official title:

The Effect of Erector Spinea Plane Block on the Postoperative Analgesia in Pediatric Hip Surgery: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374396
• Other study ID #: 33779/4/20
• Status: Completed
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: February 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries, the total morphine consumption in the first postoperative day will be the primary outcome and the time to first request for rescue analgesia and postoperative pain score will be the secondary outcome.

The study will be carried out on pediatric patients undergoing hip surgery where they will receive real or sham ultrasound guided erector spinae plane block before the onset of the surgery.

Description:

This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries.

Primary outcome: Total morphine consumption in the first postoperative day. Secondary outcome: The time to first request for rescue analgesia and postoperative pain score.

This clinical trial will be carried out in Tanta University Hospitals for a period of 6 month that may be extended on pediatric patients scheduled for surgical treatment of hip disorder under general anesthesia.

A written informed consent will be obtained from the parents of all patients. Randomization will be performed by an independent data manager assigned the patients to groups based on a computer-generated randomization program introduced in closed opaque envelope.

Group 1 (20 patients): patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at the level of second lumbar vertebra after induction of anesthesia and before the start of surgery without injection of local anesthetics.

Group 2 (20 patients): patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block att the level of second lumbar vertebra after induction of anesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine.

Anesthetic technique All the patients will be adequately assessed preoperatively in the anesthesia clinic through history taking, general and local examination, and requesting investigation. Adequate explanation of the procedure, benefit, and potential hazards will be done to the parents with final reassurance of them. All children will receive sedation in the form of oral midazolam 0.5 mg/kg 15 minutes before admission to the operating room.

Upon admission to the operating room, intravascular access will be obtained with starting i.v infusion of Dextrose 5% in normal saline (7 ml/kg). Then, the patients will be attached to a monitor of pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide, temperature, and 5 leads electrocardiogram. Induction of anesthesia will be carried out using sevoflurane 6% in oxygen: air (4:1) till the child loss the consciousness, then, fentanyl 0.5 ug/kg will be given intravenously and atracurium 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation. A suitable sized endotracheal tube will be introduced and secured with connection of the patients to a mechanical ventilator (pressure-controlled mode) which parameters will be adjusted to maintain end-tidal carbon dioxide 36-40 mmHg.

Anesthesia will be maintained by sevoflurane (1 MAC) with incremental doses of atracurium. Also, incremental doses of fentanyl 0.5 ug/kg will be given i.v in case of increase bispectral index (BIS) more than 60 or by increase in the heart rate or the mean arterial pressure by more than 20% of the baseline values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• Children aged between 1-5 years old, of both sexes, American Society of Anesthesiologists (ASA) physical status class I-II and scheduled for surgical treatment of hip disorder under general anesthesia will be included in this study

Exclusion Criteria:

1. Parental refusal.

2. Preexisting spinal deformity or profound mental retardation.

3. Obese Children

4. Known or suspected allergy to local anesthetics.

5. Known or suspected coagulopathy

6. Major cardiac, renal, or hepatic disorders.

7. Children undergoing combined or bilateral surgeries.

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Real ultrasound-guided single shot erector spinae plane block (ESP B)
ESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 mL/kg- of bupivacaine 0.25% will be injected confirming correct position by visualizing the solution lifting the ESM off the transverse process .Spread of LA between the L1 and L4 transverse processes will be thereafter visually tracked with the transducer. In the control group, no local anesthetics will be injected.

Radiation:
• Sham ultrasound-guided single shot erector spinae plane block (ESP B)
EESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. No local anesthetics will be injected

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Tanta	Algharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption in the first postoperative day	Calculation of the total dose of morphine consumed in the first day after surgery	The first 24 hours after surgery
Secondary	The time to first request for rescue analgesia	The time interval from the end of the surgery till the first dose of morphine administrated	The first 24 hours after surgery
Secondary	Postoperative pain score	The postoperative pain score (CHEOPS pain score)	every 2 hours in the first 8 hours then every 4 hours till 24 hours