Post Operative PainNCT06661746
Efficient Postoperative Pain Management With Multimodal IV
A study testing Multimodal IV analgesia and epidural analgesia in people with Post Operative Pain, run by Benha University at 1 site in Egypt.
Trial summary
Postoperative pain remains a prevalent concern despite ongoing improvements in surgical methods and pain management strategies. Opioids, while commonly prescribed, frequently lead to undesirable side effects. Epidural analgesia, though a viable option, carries its risks and complications. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Multimodal IV analgesia and epidural analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 15 Nov 2024
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were assigned for surgical intervention;
- Patients of ASA grade I-III;
- Patients were free of exclusion criteria;
Who cannot join
- Patients who are not in ASA grade I-III;
- Patients who had uncontrolled hypertension and/or diabetes mellitus;
- Patients who had uncompensated cardiac, renal, or hepatic diseases;
- Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
- Patients who refused to sign the informed consent were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Intravenous Analgesia Using Half-dose of Ketamine, Lidocaine and Magnesium Sulfate Provides Efficient Postoperative Analgesia for Patients Undergoing Major Abdominal Surgery: Randomized, Case-controlled Study
Postoperative pain remains a prevalent concern despite ongoing improvements in surgical methods and pain management strategies. Opioids, while commonly prescribed, frequently lead to undesirable side effects. Epidural analgesia, though a viable option, carries its risks and complications. Recent research indicates that combining intravenous lidocaine and ketamine can significantly alleviate postoperative pain and decrease the reliance on opioids within the initial 24 hours following surgery. This approach offers a promising alternative with minimal additional adverse effects, suggesting a potential shift in pain management practices.
- Conditions
- Post Operative Pain
- Being tested
- Multimodal IV analgesia, epidural analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal IV analgesiaDrug
Multimodal IV analgesia of lidocaine, ketamine and MS
epidural analgesiaDrug
Opioid-based and epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Group | Active comparator | Not described Receives: Drug: Multimodal IV analgesia |
| Epidural Group | Active comparator | Not described Receives: Drug: epidural analgesia |
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.
Value of Multimodal injection in Pain Reduction post operatively manifested by recurrence of pain.
Measured: 3 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 start15 Jul 2024
- Primary completion30 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman M Elafifi, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661746
- Sponsor's protocol ID
- Rc 1-7-2024
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2024
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intravenous Analgesia Using Half-dose of Ketamine, Lidocaine and Magnesium Sulfate Provides Efficient Postoperative Analgesia for Patients Undergoing Major Abdominal Surgery: Randomized, Case-controlled Study
- ClinicalTrials.gov ID
- NCT06661746
- Acronym / sponsor ID
- Rc 1-7-2024
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (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.
Postoperative pain remains a prevalent concern despite ongoing improvements in surgical methods and pain management strategies. Opioids, while commonly prescribed, frequently lead to undesirable side effects. Epidural analgesia, though a viable option, carries its risks and complications. Recent research indicates that combining intravenous lidocaine and ketamine can significantly alleviate postoperative pain and decrease the reliance on opioids within the initial 24 hours following surgery. This approach offers a promising alternative with minimal additional adverse effects, suggesting a potential shift in pain management practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Group | Active comparator | Drug: Multimodal IV analgesia |
| Epidural Group | Active comparator | Drug: epidural analgesia |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients were assigned for surgical intervention;
- Patients of ASA grade I-III;
- Patients were free of exclusion criteria;
Key exclusion criteria (5 listed)
- Patients who are not in ASA grade I-III;
- Patients who had uncontrolled hypertension and/or diabetes mellitus;
- Patients who had uncompensated cardiac, renal, or hepatic diseases;
- Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
- Patients who refused to sign the informed consent were excluded from the study.
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 |
|---|---|---|
| Multimodal IV analgesiaMultimodal IV analgesia of lidocaine, ketamine and MS | Drug | Multimodal Group |
| epidural analgesiaOpioid-based and epidural analgesia | Drug | Epidural Group |
Primary outcome
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative follow up.
Time frame: 3 months
Value of Multimodal 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 24 Dec 2024.
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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 Multimodal IV analgesia and epidural analgesia in people with Post Operative Pain, 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 3 inclusion and 5 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 Dec 2024. 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. (time frame: 3 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 24 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.