Spinal DecompressionNCT07001605
Erector Spinae Block Vs Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery
A study testing ketamine, Erector Spinae Plane Block and Wound infiltration in people with Spinal Decompression and Analgesia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Decompression, Analgesia, Erector Spinae Plane Block
- What is being tested?
- ketamine, Erector Spinae Plane Block and Wound infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2025to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Spinal Decompression, Analgesia, Erector Spinae Plane Block, Ketamine
- Being tested
- ketamine, Erector Spinae Plane Block, Wound infiltration
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
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 BlockOther
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 infiltrationOther
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
| Study group | Role | What they receive |
|---|---|---|
| ketamine group | Active comparator | Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery. Receives: Drug: ketamine; Other: Wound infiltration |
| ESPB group | Active comparator | Patients will be receiving erector spinae plane block Receives: Other: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery
using the QoR-15 questionnaire
Measured: 24 hour to 25 hour after surgery
Secondary outcomes (3)
pain assessment
numerical rating scale
Measured: 30 minutes postoperatively till 24 hours postoperatively
nalbuphine requirement
mg
Measured: 30 minutes postoperatively till 24 hours postoperatively
time to rescue analgesia
hours
Measured: 30 minutes postoperatively till 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start20 Jun 2025
- Primary completion15 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DecompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001605
- Sponsor's protocol ID
- N-18-2025
- Status last verified
- Mar 2026
- First submitted
- 15 May 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data used for statistical analysis are available from the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07001605
- Acronym / sponsor ID
- N-18-2025
- Conditions
- Spinal Decompression, Analgesia, Erector Spinae Plane Block, Ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine group | Active comparator | Drug: ketamine, Other: Wound infiltrationPatients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery. |
| ESPB group | Active comparator | Other: Erector Spinae Plane BlockPatients will be receiving erector spinae plane block |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamineafter 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. | Drug | ketamine group |
| Erector Spinae Plane Blockafter 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. | Other | ESPB group |
| Wound infiltrationwound 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 | Other | ketamine group |
Primary outcome
quality of recovery
Time frame: 24 hour to 25 hour after surgery
using the QoR-15 questionnaire
3 secondary outcomes
pain assessment
Time frame: 30 minutes postoperatively till 24 hours postoperatively
nalbuphine requirement
Time frame: 30 minutes postoperatively till 24 hours postoperatively
time to rescue analgesia
Time frame: 30 minutes postoperatively till 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. data used for statistical analysis are available from the PI upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine, Erector Spinae Plane Block and Wound infiltration in people with Spinal Decompression and Analgesia, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of recovery (time frame: 24 hour to 25 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.