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

NCT07001605 | Completed

• 1 other identifier: N-18-2025
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Decompression; Analgesia; Erector Spinae Plane Block; Ketamine

Outcome Measures

Primary Outcomes (1)

• quality of recovery

  using the QoR-15 questionnaire

  24 hour to 25 hour after surgery

Secondary Outcomes (3)

• pain assessment

  30 minutes postoperatively till 24 hours postoperatively

• nalbuphine requirement

  30 minutes postoperatively till 24 hours postoperatively

• time to rescue analgesia

  30 minutes postoperatively till 24 hours postoperatively

Study Arms (2)

ketamine group

ACTIVE COMPARATOR

Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery.

Drug: ketamine; Other: Wound infiltration

ESPB group

ACTIVE COMPARATOR

Patients will be receiving erector spinae plane block

Other: Erector Spinae Plane Block

Interventions

ketamine DRUG

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.

ketamine group

Erector Spinae Plane Block OTHER

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.

ESPB group

Wound infiltration OTHER

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

ketamine group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 3, 2025
• Study Start: June 20, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 16, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)