Post-operative PainPhase 4NCT01902108
Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine
A Phase 4 study testing Bupivacaine and Clonidine in people with Post-operative Pain, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Bupivacaine and Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 4
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First (not recurrent) posterior spinal surgery at the operated site
- American Society of Anesthesiologists class I or II (operative risk)
Who cannot join
- Allergy to local anesthetics or to clonidine
- Pregnancy
- Raynaud's syndrome
- Thromboangiitis obliterans
- History of substance abuse
- Current treatment with corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blind Trial Comparing the Post-operative Analgesic Efficacy of Local Wound Infiltration With Bupivacaine Alone to Bupivacaine With Clonidine in Posterior Spine Surgeries
The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.
Read the detailed description
Patients candidates to posterior spine surgery (Micro-discectomy, Lumbar laminectomy with or without fusion, cervical laminectomy) are asked to participate to this prospective study. After verification of inclusion and exclusion criteria, patients consenting to enter the study are randomly assigned to one of the following subgroups: 1-Pre-incisional wound infiltration with 20 mL of bupivacaine 0.25%. 2- Pre-incisional wound infiltration with 150 μg of clonidine with 20 mL of bupivacaine 0.25%. Demographic parameters, co-morbidities and other pre and per operative medical data are noted. In the post-operative period, patients received a standardized post-operative analgesic protocol (NSAI and paracetamol). Patients are asked to fill their pain diary using Visual Analog Scale (VAS) from day 0 till day 8 after surgery. Morphine rescue consumption is noted. Finally, the percentage of global subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to 100.
- Conditions
- Post-operative Pain
- Being tested
- Bupivacaine, Clonidine
- Keywords
- clonidine, bupivacaine, post-operative pain, arthrodesis, discectomy, local infiltration
- Medical subject headings
- Pain, Postoperative, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone
ClonidineDrug
Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Experimental | Clonidine 150μg added to bupivacaine in a local infiltration before wound incision Receives: Drug: Clonidine |
| Bupivacaine | Active comparator | Bupivacaine 0.25 % alone in the wound infiltration Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area under curve
Pain is assessed on numeric rating scale (NRS) 8times/day during the first 3 days, 3times/day during the next 6days and one mean value during the night. The mean intensity of daily pain is obtained from the different values mentioned during day and night corrected by the duration covered by every value. It may vary from 0 to 10.
Measured: From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h
Secondary outcomes (3)
Area under Curve (AUC) of pain
The AUC during an interval (in days) is calculated by adding the different values of pain assessed during day and night multiplied by the duration (in hours) of sufferance from this amount of pain. The AUC during an interval is proportional to the mean intensity of pain suffered during the same interval. It is expressed in pain unit multiplied by hour
Measured: Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8
Daily rescue opiates consumption
The unit of rescue opiates consumption equals the administration of 5mg of morphine subcutaneously. The minimum interval between 2 rescue opiates consumption is 6 hours. Thus, the rescue opiates consumption may vary from 0 to 4/day.
Measured: From the day of surgery till the 3rd postoperative day
Global subjective patient satisfaction of post-operative wound pain control
It may vary from 0 that means a total dissatisfaction to 100% that means a complete satisfaction
Measured: Assessed at the end of follow-up on Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon
- Investigators
- Joseph Maarrawi, MD, PhD, Principal investigator, Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902108
- Sponsor's protocol ID
- CLON-POBPC
- Status last verified
- Dec 2015
- First submitted
- 7 Jul 2013
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdel Hay J, Kobaiter-Maarrawi S, Tabet P, Moussa R, Rizk T, Nohra G, Okais N, Samaha E, Maarrawi J. Bupivacaine Field Block With Clonidine for Postoperative Pain Control in Posterior Spine Approaches: A Randomized Double-Blind Trial. Neurosurgery. 2018 Jun 1;82(6):790-798. doi: 10.1093/neuros/nyx313.
PubMed 28973650
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Trial Comparing the Post-operative Analgesic Efficacy of Local Wound Infiltration With Bupivacaine Alone to Bupivacaine With Clonidine in Posterior Spine Surgeries
- ClinicalTrials.gov ID
- NCT01902108
- Acronym / sponsor ID
- CLON-POBPC
- Conditions
- Post-operative Pain
- Keywords
- clonidine, bupivacaine, post-operative pain, arthrodesis, discectomy, local infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jul 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.
The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.
Detailed description
Patients candidates to posterior spine surgery (Micro-discectomy, Lumbar laminectomy with or without fusion, cervical laminectomy) are asked to participate to this prospective study. After verification of inclusion and exclusion criteria, patients consenting to enter the study are randomly assigned to one of the following subgroups: 1-Pre-incisional wound infiltration with 20 mL of bupivacaine 0.25%. 2- Pre-incisional wound infiltration with 150 μg of clonidine with 20 mL of bupivacaine 0.25%. Demographic parameters, co-morbidities and other pre and per operative medical data are noted. In the post-operative period, patients received a standardized post-operative analgesic protocol (NSAI and paracetamol). Patients are asked to fill their pain diary using Visual Analog Scale (VAS) from day 0 till day 8 after surgery. Morphine rescue consumption is noted. Finally, the percentage of global subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to 100.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Experimental | Drug: ClonidineClonidine 150μg added to bupivacaine in a local infiltration before wound incision |
| Bupivacaine | Active comparator | Drug: BupivacaineBupivacaine 0.25 % alone in the wound infiltration |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First (not recurrent) posterior spinal surgery at the operated site
- American Society of Anesthesiologists class I or II (operative risk)
Key exclusion criteria (6 listed)
- Allergy to local anesthetics or to clonidine
- Pregnancy
- Raynaud's syndrome
- Thromboangiitis obliterans
- History of substance 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 |
|---|---|---|
| BupivacaineLocal infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone | Drug | Bupivacaine |
| ClonidineClonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision | Drug | Clonidine |
Primary outcome
Mean Area under curve
Time frame: From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h
Pain is assessed on numeric rating scale (NRS) 8times/day during the first 3 days, 3times/day during the next 6days and one mean value during the night. The mean intensity of daily pain is obtained from the different values mentioned during day and night corrected by the duration covered by every value. It may vary from 0 to 10.
3 secondary outcomes
Area under Curve (AUC) of pain
Time frame: Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8
Daily rescue opiates consumption
Time frame: From the day of surgery till the 3rd postoperative day
Global subjective patient satisfaction of post-operative wound pain control
Time frame: Assessed at the end of follow-up on Day 8
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 8 Dec 2015.
- Derived from this study: PubMed 28973650Abdel Hay J, Kobaiter-Maarrawi S, Tabet P, Moussa R, Rizk T, Nohra G, Okais N, Samaha E, Maarrawi J. Bupivacaine Field Block With Clonidine for Postoperative Pain Control in Posterior Spine Approaches: A Randomized Double-Blind Trial. Neurosurgery. 2018 Jun 1;82(6):790-798. doi: 10.1093/neuros/nyx313.
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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.
Joseph Maarrawi, MD, PhD principal investigator
Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Clonidine in people with Post-operative Pain, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 8 Dec 2015. 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 Lebanon. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean Area under curve (time frame: From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902108, which also lists 1 linked publication.
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 8 Dec 2015.