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

Not Applicable

Recruiting

• Conditions: Ketamine; Spinal Decompression; Analgesia; Erector Spinae Plane Block
• Interventions: Drug: ketamine; Other: Erector Spinae Plane Block; Other: Wound infiltration

• Registration Number: NCT07001605
• Lead Sponsor: Kasr El Aini Hospital

Brief 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 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.

Study Timeline

• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-03
• Study Start: 2025-06-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-06
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• American Society of Anesthesiologists (ASA) status of I-III
• scheduled for open lumber decompression surgery for degenerative stenosis or trauma involving 1or 2 levels without fusion.

Exclusion Criteria

• Refusal to participate
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine group	ketamine	Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery.
ketamine group	Wound infiltration	Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery.
ESPB group	Erector Spinae Plane Block	Patients will be receiving erector spinae plane block

Primary Outcome Measures

Name	Time	Method
quality of recovery	24 hour to 25 hour after surgery	using the QoR-15 questionnaire

Secondary Outcome Measures

Name	Time	Method
pain assessment	30 minutes postoperatively till 24 hours postoperatively	numerical rating scale
nalbuphine requirement	30 minutes postoperatively till 24 hours postoperatively	mg
time to rescue analgesia	30 minutes postoperatively till 24 hours postoperatively	hours

Trial Locations

Locations (1)

Kasr Alaini Hospital; 🇪🇬 Cairo, Egypt