Erector Spinae Plane Block in Scoliotic Adolescents

NCT ID: NCT03968146

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2019-12-02

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.

Detailed Description

All patients will be assessed clinically and investigated for Pulmonary function test and Echocardiography. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) and liver function tests.

an online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the two study groups. Random allocation numbers will be concealed in opaque closed envelops.participants and those assessing/analyzing the outcome(s) will be blind to group assignment.

Eutectic Mixture of Local Anesthetics (EMLA) cream will be applied to the site of venous puncture. After insertion of venous access, all children will receive midazolam at a dose of 0.1 mg/Kg. Intraoperative monitoring will include continuous electrocardiogram (ECG), pulse oximetry, invasive arterial blood pressure, end-tidal carbon dioxide (CO2), inhaled gas analyzer and temperature monitoring.

General anesthesia will be induced in both groups (Erector Spinae group and control group) using propofol 2.5 mg/kg over 20-30 seconds, atracurium 0.5 mg/kg to facilitate endotracheal intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium infused as 0.5 mg/kg/hr. All patients will receive IV ranitidine 2 mg/kg, ondansetron 0.1 mg/kg, cefotaxime 50 mg/kg and acetaminophen 15 mg/kg. An arterial catheter and a urinary catheter will be placed. Then patients will be turned to the prone position.

In group E: will receive Erector Spinae Plane Block (ESPB) In group C: control group will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision. After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.

In both groups, if the analgesia obtained from both methods of ESBP or IV fentanyl 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). Total blood loss, duration of surgery, number of vertebral levels fixed, total fentanyl consumed will be recorded. After completion of surgical procedure and emergence from anesthesia the patient will be referred to post-anaesthesia care unit (PACU). Quality of analgesia will be assessed immediately postoperative and then at 4, 8, 12, 16, and 24 hours postoperatively in the Intensive Care Unit (ICU) by using VAS pain score. All patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours, ketorolac from second day 15 mg q 6 hours, not to exceed 5 days. Patients will also receive ranitidine 2 mg/kg q 12 hours. Vital signs and urinary output will be monitored. Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if visual analogue scale (VAS) pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr. After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg. Morphine will be stopped if maximum hourly dose is reached or the patient becomes sedated (Ramsay score >2), has a ventilatory rate of <12 bpm, or an oxygen saturation of <95%, or has a serious adverse event (allergy, hypotension, severe vomiting).

Patients will be continuously monitored in the PACU and ICU. Naloxone and full resuscitation equipment are available. Time of first need for morphine and total 24 hr morphine consumption will be recorded. Complications e.g nausea, vomiting, pruritis or respiratory depression will be recorded.

Conditions

Scoliosis Idiopathic; Scoliosis; Adolescence; Erector Spinae Plane Block

Study Design

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

Study Groups

Group E

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

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: 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.

Fentanyl

Intervention Type: 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).

rescue Morphine

Intervention Type: 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.

pethidine

Intervention Type: 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.

Ketorolac

Intervention Type: DRUG

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

Acetaminophen

Intervention Type: DRUG

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

Group C

Control group will receive only intravenous fentanyl.

Group Type: OTHER

Fentanyl

Intervention Type: 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).

additional Fentanyl

Intervention Type: DRUG

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

Morphine

Intervention Type: DRUG

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

rescue Morphine

Intervention Type: 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.

pethidine

Intervention Type: 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.

Ketorolac

Intervention Type: DRUG

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

Acetaminophen

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

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).

Intervention Type: DRUG

additional Fentanyl

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

Intervention Type: DRUG

Morphine

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Ketorolac

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

Intervention Type: DRUG

Acetaminophen

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

Intervention Type: DRUG

Other Intervention Names

fentanyl for induction and maintenance; morphine infusion

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

maged gamal

anethesia demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-15-2019

Identifier Type: -

Identifier Source: org_study_id