Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine SurgeriesNCT03463083
Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries
A study testing Dexmedetomidine, Bupivacaine and Fentanyl in people with Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries, run by Cairo University at 1 site in Egypt.
Trial summary
To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries
- What is being tested?
- Dexmedetomidine, Bupivacaine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2018to 6 May 2018
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All male patients between the age group of 18 and 65 years
- Patients of American Society of Anaesthesiologists (ASA) class I and II.
- Patients who will undergo lumbar spine surgeries (laminectomy ± discectomy for PIVD (Prolapse of intervertebral disc), will be enrolled for this study
Who cannot join
- All Patients below the age of 18 years and above 65 years. Also All female patient are excluded from the study.
- Other spine surgeries rather than laminectomy, also surgeries on more than two levels.
- Patients with haematological disease, bleeding or coagulation test abnormalities, psychiatric diseases.
- 4 .Patiensts with history of drug abuse, allergy to any study medication. . 4 .Patients with cervical and thoracic spine surgeries, tubercular spine , any permanent neurological disorders and vertebral deformeties such as scoliosis and spondylolisthesis.
- 5. Pregnant and lactating patients .
- Withdrawal criteria :
- Accidental Dural puncture.
Trial locations and contacts
1 site in 1 country.
About this study
To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters
Read the detailed description
Relieving post-operative pain of spine surgeries has become an indispensable component in anesthesiology. Various methods have been tried for the management of post-operative pain in spine surgeries out of which regional techniques are becoming most promising. The quality of regional anesthesia has been reported to improve with the addition of opioids (such as morphine, fentanyl, and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate, neostigmine, ketamine, and midazolam), but no drug to inhibit nociception is without associated adverse effects . α2 adrenergic agonists have both analgesic and sedative properties when used as an adjuvant in regional anesthesia. Dexmedetomidine is an S-enantiomer of medetomidine with a higher specificity for α2-adrenoreceptor (α2 : α1, 1620 : 1) compared to clonidine (α2 : α1, 220 : 1). It was first introduced into practical use as intravenous sedative after the approval of U.S. Food and Drug Administration in 1999. Since then it has been investigated as the anxiolytic, sympatholytic, and analgesic properties related to α2-adrenoceptor binding, and it is now being used as a co-analgesic drug. As adjuvant, neuroaxial administration is the appropriate route to dexmedetomidine, because the analgesic effect of α2-agonists mostly occurs at spinal level, and dexmedetomidin's high lipophilicity facilitates rapid absorption into the cerebrospinal fluid and binding to the spinal cord α2-adrenoreceptor. regional-administeration of dexmedetomidine has been shown to exert potent antinociceptive effects in animals. To date, a few studies have reported on the effects of epidural dexmedetomidine combined with local anesthetics in humans. . Administration of an α2-agonist via an intrathecal or epidural route provides an analgesic effect in postoperative pain without severe sedation. This effect is due to the sparing of supraspinal CNS sites from excessive drug exposure, resulting in robust analgesia without heavy sedation . The adverse effects of dexmedetomidine include hypotension, hypertension, nausea, bradycardia, atrial fibrillation, and hypoxia. Fentanyl is one of the short-acting narcotic analgesics with potent morphine-like action . Neuroaxial administration of lipophilic opioids such as Fentanyl and sufentanyl tends to provide a rapid onset of analgesia. Their rapid clearance from cerebrospinal fluid may limit cephalic spread and the development of certain side effects such as delayed respiratory depression
- Being tested
- Dexmedetomidine, Bupivacaine, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine bupivacaine versus fentanyl bupivacaine
All cases of spine surgery will be done under G.A with the patient in prone position. After surgery an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
- The pain score, by using VAS
- Onset of analgesia (fall of VAS<4 ).
- Peak level of analgesia ( VAS score 0).
- Duration of analgesia (once the patient asks fwith VAS>4).
- Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
- Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.
BupivacaineDrug
All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
- The pain score, by using VAS
- Onset of analgesia (fall of VAS<4 ).
- Peak level of analgesia ( VAS score 0).
- Duration of analgesia (once the patient asks fwith VAS>4).
- Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
- Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.
FentanylDrug
All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
- The pain score, by using VAS
- Onset of analgesia (fall of VAS<4 ).
- Peak level of analgesia ( VAS score 0).
- Duration of analgesia (once the patient asks fwith VAS>4).
- Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
- Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine dexmedetomidine group | Active comparator | Group 1 (bupivacaine + dexmedetomidine (BD) group); will Receive an epidural study solution of 18 ml of 0.25% of bupivacaine hydrochloride plus 1 ml of dexmedetomidine (1 mcg/kg) plus 1 ml normal saline keeping the total volume of 20 ml in a syringe pump . Receives: Drug: Dexmedetomidine; Drug: Bupivacaine |
| Bupivacaine fentanyl group | Active comparator | Group 2 (bupivacaine + fentanyl (BF) group) ; will Receive an epidural study solution of 18 ml of 0.25% bupivacaine plus 2 ml fentanyl (1 mcg/kg) keeping the total volume of 20 ml in a syringe pump . Receives: Drug: Bupivacaine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative analgesia duration assessment
The duration of effective analgesia; "it is the duration of complete pain relief (zero pain) and ends by the appearance of any pain (even VAS is of one)."
Measured: 24 hours
Secondary outcomes (9)
Post-operative assessment of pain
Post-operative assessment of pain using The Visual Analogue Scale (VAS: 0= no pain and 10 = worst possible pain).
Measured: 24 hours
Complete sensory and motor block
Time taken to achieve complete sensory and motor block
Measured: 24 hours
Sedation assessment
Post operative assessment of sedation using modified Ramsay scale (Grade 1, Patient is anxious and agitated or restless, 2, Patient is co-operative, oriented, and tranquil, 3, Patient responds to commands only; 4, Patient exhibits brisk response to light glabellar tap or loud auditory stimulus,5, Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus,6, Patient exhibits no response )
Measured: 24 hours
Heart rate monitoring
Perioperative hemodynamics
Measured: 24 hours
Mean arterial blood pressure
Perioperative hemodynamics
Measured: 24 hours
Vomiting assessment
Post-operative assessment of vomiting
Measured: 24 hours
Itching assessment
Post-operative assessment of itching
Measured: 24 hours
Urine retention assessment
Post-operative assessment of urine retention
Measured: 24 hours
Post-operative Neusea
Post-operative Neusea assessment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start4 Mar 2018
- Primary completion2 May 2018
- Study completion6 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine SurgeriesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This double-blind, prospective, randomised clinically controlled study is designed to study the efficacy of epidural analgesia of dexmedetomidine and compare the analgesic effect of its epidural injection with bupivacaine versus fentanyl with bupivacaine in the post operative period of elective spine surgeries. To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan, Mohamed Mahmoud Mohamed, ismaiel saied hammad
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463083
- Sponsor's protocol ID
- N-115-2017
- Status last verified
- May 2018
- First submitted
- 29 Dec 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Via scholar Gate
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries
- ClinicalTrials.gov ID
- NCT03463083
- Acronym / sponsor ID
- N-115-2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan, Mohamed Mahmoud Mohamed, ismaiel saied hammad
- Study start
- 4 Mar 2018 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 6 May 2018 (actual)
- First posted
- 13 Mar 2018 (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.
To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters
Detailed description
Relieving post-operative pain of spine surgeries has become an indispensable component in anesthesiology. Various methods have been tried for the management of post-operative pain in spine surgeries out of which regional techniques are becoming most promising. The quality of regional anesthesia has been reported to improve with the addition of opioids (such as morphine, fentanyl, and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate, neostigmine, ketamine, and midazolam), but no drug to inhibit nociception is without associated adverse effects . α2 adrenergic agonists have both analgesic and sedative properties when used as an adjuvant in regional anesthesia. Dexmedetomidine is an S-enantiomer of medetomidine with a higher specificity for α2-adrenoreceptor (α2 : α1, 1620 : 1) compared to clonidine (α2 : α1, 220 : 1). It was first introduced into practical use as intravenous sedative after the approval of U.S. Food and Drug Administration in 1999. Since then it has been investigated as the anxiolytic, sympatholytic, and analgesic properties related to α2-adrenoceptor binding, and it is now being used as a co-analgesic drug. As adjuvant, neuroaxial administration is the appropriate route to dexmedetomidine, because the analgesic effect of α2-agonists mostly occurs at spinal level, and dexmedetomidin's high lipophilicity facilitates rapid absorption into the cerebrospinal fluid and binding to the spinal cord α2-adrenoreceptor. regional-administeration of dexmedetomidine has been shown to exert potent antinociceptive effects in animals. To date, a few studies have reported on the effects of epidural dexmedetomidine combined with local anesthetics in humans. . Administration of an α2-agonist via an intrathecal or epidural route provides an analgesic effect in postoperative pain without severe sedation. This effect is due to the sparing of supraspinal CNS sites from excessive drug exposure, resulting in robust analgesia without heavy sedation . The adverse effects of dexmedetomidine include hypotension, hypertension, nausea, bradycardia, atrial fibrillation, and hypoxia. Fentanyl is one of the short-acting narcotic analgesics with potent morphine-like action . Neuroaxial administration of lipophilic opioids such as Fentanyl and sufentanyl tends to provide a rapid onset of analgesia. Their rapid clearance from cerebrospinal fluid may limit cephalic spread and the development of certain side effects such as delayed respiratory depression
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This double-blind, prospective, randomised clinically controlled study is designed to study the efficacy of epidural analgesia of dexmedetomidine and compare the analgesic effect of its epidural injection with bupivacaine versus fentanyl with bupivacaine in the post operative period of elective spine surgeries. To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine dexmedetomidine group | Active comparator | Drug: Dexmedetomidine, Drug: BupivacaineGroup 1 (bupivacaine + dexmedetomidine (BD) group); will Receive an epidural study solution of 18 ml of 0.25% of bupivacaine hydrochloride plus 1 ml of dexmedetomidine (1 mcg/kg) plus 1 ml normal saline keeping the total volume of 20 ml in a syringe pump . |
| Bupivacaine fentanyl group | Active comparator | Drug: Bupivacaine, Drug: FentanylGroup 2 (bupivacaine + fentanyl (BF) group) ; will Receive an epidural study solution of 18 ml of 0.25% bupivacaine plus 2 ml fentanyl (1 mcg/kg) keeping the total volume of 20 ml in a syringe pump . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All male patients between the age group of 18 and 65 years
- Patients of American Society of Anaesthesiologists (ASA) class I and II.
- Patients who will undergo lumbar spine surgeries (laminectomy ± discectomy for PIVD (Prolapse of intervertebral disc), will be enrolled for this study
Key exclusion criteria (7 listed)
- All Patients below the age of 18 years and above 65 years. Also All female patient are excluded from the study.
- Other spine surgeries rather than laminectomy, also surgeries on more than two levels.
- Patients with haematological disease, bleeding or coagulation test abnormalities, psychiatric diseases.
- 4 .Patiensts with history of drug abuse, allergy to any study medication. . 4 .Patients with cervical and thoracic spine surgeries, tubercular spine , any permanent neurological disorders and vertebral deformeties such as scoliosis and spondylolisthesis.
- 5. Pregnant and lactating patients .
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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine bupivacaine versus fentanyl bupivacaineAll cases of spine surgery will be done under G.A with the patient in prone position. After surgery an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted . 1. The pain score, by using VAS 2. Onset of analgesia (fall of VAS<4 ). 3. Peak level of analgesia ( VAS score 0). 4. Duration of analgesia (once the patient asks fwith VAS>4). 5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min. 6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension. | Drug | Bupivacaine dexmedetomidine group |
| BupivacaineAll cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted . 1. The pain score, by using VAS 2. Onset of analgesia (fall of VAS<4 ). 3. Peak level of analgesia ( VAS score 0). 4. Duration of analgesia (once the patient asks fwith VAS>4). 5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min. 6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension. | Drug | Bupivacaine dexmedetomidine group, Bupivacaine fentanyl group |
| FentanylAll cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted . 1. The pain score, by using VAS 2. Onset of analgesia (fall of VAS<4 ). 3. Peak level of analgesia ( VAS score 0). 4. Duration of analgesia (once the patient asks fwith VAS>4). 5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min. 6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension. | Drug | Bupivacaine fentanyl group |
Primary outcome
Post-operative analgesia duration assessment
Time frame: 24 hours
The duration of effective analgesia; "it is the duration of complete pain relief (zero pain) and ends by the appearance of any pain (even VAS is of one)."
9 secondary outcomes
Post-operative assessment of pain
Time frame: 24 hours
Complete sensory and motor block
Time frame: 24 hours
Sedation assessment
Time frame: 24 hours
Heart rate monitoring
Time frame: 24 hours
Mean arterial blood pressure
Time frame: 24 hours
Vomiting assessment
Time frame: 24 hours
Itching assessment
Time frame: 24 hours
Urine retention assessment
Time frame: 24 hours
Post-operative Neusea
Time frame: 24 hours
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 30 May 2018.
- Individual participant dataSharing planned: No. Via scholar Gate
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 Dexmedetomidine, Bupivacaine and Fentanyl in people with Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries, run by Cairo 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 7 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 30 May 2018. 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?
Post-operative analgesia duration assessment (time frame: 24 hours). 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 30 May 2018.