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CompletedNCT07001605Updated Mar 24, 2026

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

An interventional study of ketamine and Erector Spinae Plane Block in Spinal Decompression, Analgesia and Erector Spinae Plane Block, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 62 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

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Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    ketamine group

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

    Drug: ketamine · Other: Wound infiltration

  • Active comparator
    ESPB group

    Patients will be receiving erector spinae plane block

    Other: Erector Spinae Plane Block

Interventions

  • Drugketamine

    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.

  • OtherErector 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.

  • OtherWound 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

06

What researchers measure

Primary outcomes

  1. quality of recovery

    using the QoR-15 questionnaire

    Time frame: 24 hour to 25 hour after surgery

Secondary outcomes

  1. pain assessment

    numerical rating scale

    Time frame: 30 minutes postoperatively till 24 hours postoperatively

  2. nalbuphine requirement

    mg

    Time frame: 30 minutes postoperatively till 24 hours postoperatively

  3. time to rescue analgesia

    hours

    Time frame: 30 minutes postoperatively till 24 hours postoperatively

07

Study locations

1 site
  • Kasr Alaini Hospital
    Cairo, 11562, Egypt
08

References and documents

Individual participant data

Plan to share: No — data used for statistical analysis are available from the PI upon reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07001605
Lead sponsor
Kasr El Aini Hospital
Responsible party
Maha Mostafa Ahmad, MD (Principal Investigator, Kasr El Aini Hospital) — Principal investigator
First posted
Jun 3, 2025
Start date
Jun 20, 2025
Primary completion
Dec 15, 2025
Completion
Dec 16, 2025
Last update
Mar 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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