Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-10 @ 12:17 AM
Study NCT ID:
NCT07001605
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Block Vs Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery
Sponsor:
Kasr El Aini Hospital
Organization:
Study Overview
Official Title:
Comparing the Quality of Recovery of Erector Spinae Block Versus Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery: a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: