Pain, PostoperativeNCT06662318
Perioperative Pain Management for Lumbar Spine Surgery
A study testing Fentanyl Citrate, Dexmedetomidine and Lidocaine Hydrochloride in people with Pain, Postoperative, run by Benha University at 1 site in Egypt.
Trial summary
Perioperative pain management is crucial for patients undergoing elective lumbar spine surgery. Moderate to severe postoperative pain can significantly impact recovery, worsen patient outcomes, and potentially lead to chronic pain. Opioids have traditionally been the mainstay of postoperative pain management. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Fentanyl Citrate, Dexmedetomidine and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 15 Jan 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had LDD and required lumbar discectomy,
- Patients are free of exclusion criteria and accepted to participate in the study.
Who cannot join
- The presence of other indications for spinal surgery;
- Obesity of grade ≥II;
- Patients of ASA grade >II;
- opioid dependence for preoperative pain;
- The presence of other causes of preoperative pain;
- The presence of preoperative psychiatric manifestations especially delirium and/or cognitive dysfunction;
- The presence of contraindications for the use of the study drugs;
- The presence of uncontrolled cardiac, renal, or hepatic disorders and essential hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgesic Manipulations to Mitigate Pain After Elective Lumbar Spinal Surgeries: A Prospective Case-controlled Study
Perioperative pain management is crucial for patients undergoing elective lumbar spine surgery. Moderate to severe postoperative pain can significantly impact recovery, worsen patient outcomes, and potentially lead to chronic pain.
Opioids have traditionally been the mainstay of postoperative pain management. However, their use is associated with several adverse effects, including nausea, vomiting, respiratory depression, and the risk of developing chronic pain. To mitigate these risks, there is a growing emphasis on multimodal analgesic approaches that combine various non-opioid medications to provide effective pain relief.
Non-opioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs), regional anesthesia techniques, and adjuvant medications, can be used to reduce opioid requirements and improve patient outcomes. By carefully selecting and combining these modalities, clinicians can optimize pain management strategies for individual patients, minimizing the need for opioids and their associated side effects.
- Conditions
- Pain, Postoperative
- Being tested
- Fentanyl Citrate, Dexmedetomidine, Lidocaine Hydrochloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
Fentanyl was given as a bolus of 1 µg/kg injected followed by a fentanyl infusion of 0.4 µg/kg/h. Fentanyl infusion was continued as Postoperative analgesia for 24 hours in a dose of 0.3 µg/kg/h.
DexmedetomidineDrug
Dexmedetomidine was given as a loading dose of 0.6 µg/kg, which was diluted to a total volume of 10 cc of normal saline and injected before induction of anesthesia over 10 minutes. Then, a DXM infusion prepared to provide 0.2-0.7 µg/kg/h was started Intraoperative; Postoperative DXM infusion was provided in a dose of 0.15 µg/kg/h for 24-h.
Lidocaine HydrochlorideDrug
Lidocaine hydrochloride was provided as 2 mg/kg slowly IV before induction of anesthesia and as an IV infusion at a rate of 3 mg/kg/h. Postoprative lidocaine infusion at a dose of 1.5 mg/kg/h was administered for 24 Postoprative hours.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Not described Receives: Drug: Lidocaine Hydrochloride |
| Group D | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Group F | Active comparator | Not described Receives: Drug: Fentanyl Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.
Value of non-opioid injection in Pain Reduction post operatively manifested by recurrence of pain.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mahrous Shaffik, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662318
- Sponsor's protocol ID
- RC 22/10/2024
- Status last verified
- Nov 2025
- First submitted
- 25 Oct 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesic Manipulations to Mitigate Pain After Elective Lumbar Spinal Surgeries: A Prospective Case-controlled Study
- ClinicalTrials.gov ID
- NCT06662318
- Acronym / sponsor ID
- RC 22/10/2024
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 28 Oct 2024 (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.
Perioperative pain management is crucial for patients undergoing elective lumbar spine surgery. Moderate to severe postoperative pain can significantly impact recovery, worsen patient outcomes, and potentially lead to chronic pain.
Opioids have traditionally been the mainstay of postoperative pain management. However, their use is associated with several adverse effects, including nausea, vomiting, respiratory depression, and the risk of developing chronic pain. To mitigate these risks, there is a growing emphasis on multimodal analgesic approaches that combine various non-opioid medications to provide effective pain relief.
Non-opioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs), regional anesthesia techniques, and adjuvant medications, can be used to reduce opioid requirements and improve patient outcomes. By carefully selecting and combining these modalities, clinicians can optimize pain management strategies for individual patients, minimizing the need for opioids and their associated side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: Lidocaine Hydrochloride |
| Group D | Active comparator | Drug: Dexmedetomidine |
| Group F | Active comparator | Drug: Fentanyl Citrate |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who had LDD and required lumbar discectomy,
- Patients are free of exclusion criteria and accepted to participate in the study.
Key exclusion criteria (8 listed)
- The presence of other indications for spinal surgery;
- Obesity of grade ≥II;
- Patients of ASA grade >II;
- opioid dependence for preoperative pain;
- The presence of other causes of preoperative pain;
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 |
|---|---|---|
| Fentanyl CitrateFentanyl was given as a bolus of 1 µg/kg injected followed by a fentanyl infusion of 0.4 µg/kg/h. Fentanyl infusion was continued as Postoperative analgesia for 24 hours in a dose of 0.3 µg/kg/h. | Drug | Group F |
| DexmedetomidineDexmedetomidine was given as a loading dose of 0.6 µg/kg, which was diluted to a total volume of 10 cc of normal saline and injected before induction of anesthesia over 10 minutes. Then, a DXM infusion prepared to provide 0.2-0.7 µg/kg/h was started Intraoperative; Postoperative DXM infusion was provided in a dose of 0.15 µg/kg/h for 24-h. | Drug | Group D |
| Lidocaine HydrochlorideLidocaine hydrochloride was provided as 2 mg/kg slowly IV before induction of anesthesia and as an IV infusion at a rate of 3 mg/kg/h. Postoprative lidocaine infusion at a dose of 1.5 mg/kg/h was administered for 24 Postoprative hours. | Drug | Group L |
Primary outcome
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.
Time frame: 2 months
Value of non-opioid injection in Pain Reduction post operatively manifested by recurrence of pain.
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 28 Nov 2025.
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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 Fentanyl Citrate, Dexmedetomidine and Lidocaine Hydrochloride in people with Pain, Postoperative, run by Benha University 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 8 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 28 Nov 2025. 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?
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery. (time frame: 2 months). 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 28 Nov 2025.