NCT07001605

Erector Spinae Block Vs Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery

Comparing the Quality of Recovery of Erector Spinae Block Versus Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the quality of recovery of the erector spinae plane block (ESPB) versus ketamine-based multimodal analgesia regimen after spine decompressive surgery.

Detailed description

Preoperatively, standard monitors will be attached (electrocardiogram, noninvasive blood pressure, and pulse oximetry) and intravenous access will be obtained. Dexamethasone will be administered at dose of 4 mg as an antiemetic prophylaxis. 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 2 mg bolus of morphine will be given. 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

• Spinal Decompression
• Analgesia
• Erector Spinae Plane Block
• Ketamine

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.
OTHER	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

Timeline

• Start date: 2025-06-20
• Primary completion: 2025-12-15
• Completion: 2025-12-16
• First posted: 2025-06-03
• Last updated: 2026-03-24

Locations

1 site across 1 country: Egypt