PainPhase 2NCT01838707
Postoperative Epidural Analgesia in Spine Fusion Surgery
A Phase 2 study testing 0.125% Bupivacaine HCL @ 4-5 ml/h, 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h and 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h in people with Pain, run by Assiut University at 1 site in Egypt.
Trial summary
we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- 0.125% Bupivacaine HCL @ 4-5 ml/h, 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h and 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2007to Mar 2013
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing spine fusion surgery.
Who cannot join
- Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.
Trial locations and contacts
1 site in 1 country.
About this study
we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.
- Conditions
- Pain
- Being tested
- 0.125% Bupivacaine HCL @ 4-5 ml/h, 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h, 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
- Keywords
- postoperative, spine surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.125% Bupivacaine HCL @ 4-5 ml/hDrug
0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/hDrug
0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/hDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | 0.125% Bupivacaine HCL @ 4-5 ml/h Receives: Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h |
| Bupivacaine, Morphine | Active comparator | 0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h Receives: Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h |
| Bupivacaine, Fentanyl | Active comparator | 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h Receives: Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
- Pain will be assessed using the VAS ranging from "0" (no pain) to "10" (worst imaginable pain). Pain will be evaluated at rest, while coughing, and during mobilization. Maneuvers of particular clinical importance for postoperative mobilization (alone and with help) will be chosen: Turning in bed, standing in front of the bed and walking, and using the toilet without help. The time needed until the patient can first successfully perform these maneuvers will be documented.
Measured: first 3 postoperative days
Secondary outcomes (1)
assessment of patients' satisfaction
verbal rating score will be used (4 = very satisfied, 3 = satisfied, 2 = neutral, 1 = dissatisfied, and 0 = very dissatisfied).
Measured: First 3 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startDec 2007
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Askar, Assiut University
- Investigators
- Omnia A Abd El Raof, M.Sc., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838707
- Sponsor's protocol ID
- 1976
- Status last verified
- Apr 2013
- First submitted
- 20 Apr 2013
- Last updated
- 25 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Epidural Analgesia in Spine Fusion Surgery
- ClinicalTrials.gov ID
- NCT01838707
- Acronym / sponsor ID
- 1976
- Conditions
- Pain
- Keywords
- postoperative, spine surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Apr 2013 (estimated)
- 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.
we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h0.125% Bupivacaine HCL @ 4-5 ml/h |
| Bupivacaine, Morphine | Active comparator | Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h |
| Bupivacaine, Fentanyl | Active comparator | Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients undergoing spine fusion surgery.
Key exclusion criteria (1 listed)
- Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.
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 |
|---|---|---|
| 0.125% Bupivacaine HCL @ 4-5 ml/h | Drug | Bupivacaine |
| 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h | Drug | Bupivacaine, Morphine |
| 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h | Drug | Bupivacaine, Fentanyl |
Primary outcome
Assessment of pain
Time frame: first 3 postoperative days
• Pain will be assessed using the VAS ranging from "0" (no pain) to "10" (worst imaginable pain). Pain will be evaluated at rest, while coughing, and during mobilization. Maneuvers of particular clinical importance for postoperative mobilization (alone and with help) will be chosen: Turning in bed, standing in front of the bed and walking, and using the toilet without help. The time needed until the patient can first successfully perform these maneuvers will be documented.
1 secondary outcome
assessment of patients' satisfaction
Time frame: First 3 postoperative days
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 25 Apr 2013.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Omnia A Abd El Raof, M.Sc. principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.125% Bupivacaine HCL @ 4-5 ml/h, 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h and 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h in people with Pain, run by Assiut 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 1 inclusion and 1 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 25 Apr 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of pain (time frame: first 3 postoperative days). 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 25 Apr 2013.