Erector Spinea Plane Block in Pediatric Hip Surgery

NCT ID: NCT04374396

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2021-02-02

Brief 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.

Detailed 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.

Conditions

Postoperative Pain; Opioid Use

Study Design

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

Study Groups

Group 1

patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery without injection of local anesthetics

Group Type: SHAM_COMPARATOR

Sham ultrasound-guided single shot erector spinae plane block (ESP B)

Intervention Type: RADIATION

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

Group 2

patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine.

Group Type: EXPERIMENTAL

Real ultrasound-guided single shot erector spinae plane block (ESP B)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Abdelkhalik Ahmed Ismaiel

Assistant Professor of Anesthesia - Tanta Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Ismaiel, M.D

Role: STUDY_DIRECTOR

Lecturer of Anesthesia and Intensive Care, Tanta University

Mohamed Abdullah, M.D

Role: STUDY_DIRECTOR

Assistant Professor of Anesthesia and Intensive Care, Tanta University

Locations

Faculty of Medicine

Tanta, Algharbia, Egypt

Countries

Egypt

Other Identifiers

33779/4/20

Identifier Type: -

Identifier Source: org_study_id