Erector Spinae Block Vs Ketamine-based Multimodal Analges... | NCT07001605

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

NCT07001605

Sponsor

Kasr El Aini Hospital

Status

Completed

Last Update Posted

Mar 24, 2026Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Spinal Decompression
Analgesia
Erector Spinae Plane Block
Ketamine

Interventions

ketamine
Erector Spinae Plane Block
Wound infiltration

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2025Actual

Primary Completion Date

Dec 15, 2025Actual

Completion Date

Dec 16, 2025Actual

First Submitted Date

May 15, 2025

First Submission Date that Met QC Criteria

Jun 2, 2025

First Posted Date

Jun 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 24, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maha Mostafa Ahmad, MD, Principal Investigator, Kasr El Aini HospitalPrincipal Investigator

Lead Sponsor

Kasr El Aini HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of recovery	using the QoR-15 questionnaire	24 hour to 25 hour after surgery

Secondary Outcomes

Measure	Description	Time Frame
pain assessment	numerical rating scale	30 minutes postoperatively till 24 hours postoperatively
nalbuphine requirement	mg	30 minutes postoperatively till 24 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alaini Hospital		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

data used for statistical analysis are available from the PI upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided