Erector Spinae Block Vs Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery
NCT ID: NCT07001605
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2025-06-20
2025-09-30
Brief Summary
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Detailed Description
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Thirty min before induction of anesthesia all patients will receive 15 mg ketorolac and 1 gm paracetamol intravenously.
General anesthesia will be induced by 1 mcg/kg fentanyl and 2 mg/kg propofol titrated till loss of verbal response. Tracheal intubation will be facilitated by 0.5 mg/kg atracurium. General anesthesia will be maintained by isoflurane (end-tidal isoflurane concentration of 1-1.2%) in air-oxygen admixture.
Fentanyl boluses of 50 mcg will be given in case of inadequate analgesia (heart rate and or systolic blood pressure increase by 20% from the baseline in absence of other causes) Intraoperative hemodynamic management will be according to the discretion of the attending anesthetist.
Postoperatively, all Patients will receive oral 1 gm of paracetamol every 6 h and 400 mg ibuprofen every 8 h.
Pain assessments using NRS (Numerical Rating Scale) at rest and during movement at 0.5 , 4, 10, 18 and 24 h postoperatively. If NRS score is \> 3, intravenous nalbuphine 0.1 mg/kg (lean body weight) titrated to response will be given (maximum single dose is 20 mg and maximum daily dose is 160 mg).
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs.
At the end of 24 h postoperatively, patient's quality of recovery will be assessed using QoR-15 questionnaire and patient's satisfaction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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ketamine group
Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery.
ketamine
after induction of anesthesia, patients will receive ketamine bolus of 0.5 mL/kg followed by continuous infusion of 0.12 mL/k/hr until the end of surgical procedure.
Wound infiltration
wound infiltration at the end of the surgery before the closure of fascia and subcutaneous tissues using a total of 20 ml of 0.25% bupivacaine
ESPB group
Patients will be receiving erector spinae plane block
Erector Spinae Plane Block
after induction of anesthesia, patients will receive ultrasound guided ESPB. A total of 40 mL of 0.25% bupivacaine will be injected bilaterally at the level of transverse process opposing to the mid-point of the planned incision.
Interventions
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ketamine
after induction of anesthesia, patients will receive ketamine bolus of 0.5 mL/kg followed by continuous infusion of 0.12 mL/k/hr until the end of surgical procedure.
Erector Spinae Plane Block
after induction of anesthesia, patients will receive ultrasound guided ESPB. A total of 40 mL of 0.25% bupivacaine will be injected bilaterally at the level of transverse process opposing to the mid-point of the planned incision.
Wound infiltration
wound infiltration at the end of the surgery before the closure of fascia and subcutaneous tissues using a total of 20 ml of 0.25% bupivacaine
Eligibility Criteria
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Inclusion Criteria
* scheduled for open lumber decompression surgery for degenerative stenosis or trauma involving 1or 2 levels without fusion.
Exclusion Criteria
* Contraindication for peripheral regional anesthesia such as infection and coagulopathy.
* Inability to comprehend the Numeric Rating Scale (NRS) or Patients who has cognitive function impairment
* Preoperative renal or hepatic insufficiency
* History of Opioid abuse.
* Allergy to any of the study drugs
20 Years
ALL
No
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Maha Mostafa Ahmad, MD
Principal Investigator
Locations
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Kasr Alaini Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Anesthesia, Pain Management and Surgical ICU Department
Role: primary
Other Identifiers
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N-18-2025
Identifier Type: -
Identifier Source: org_study_id
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