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Completed

NCT Number: NCT07001605

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alaini Hospital

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

Primary outcomes

  1. quality of recovery

    Time frame: 24 hour to 25 hour after surgery

    using the QoR-15 questionnaire

Secondary outcomes

  1. pain assessment

    Time frame: 30 minutes postoperatively till 24 hours postoperatively

    numerical rating scale

  2. nalbuphine requirement

    Time frame: 30 minutes postoperatively till 24 hours postoperatively

    mg

  3. time to rescue analgesia

    Time frame: 30 minutes postoperatively till 24 hours postoperatively

    hours

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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