Nalbuphine,Fentanyl and Local Anesthetic MixturePhase 4NCT03824665
Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture
A Phase 4 study testing Nalbuphine Group and Fentanyl Group in people with Nalbuphine,Fentanyl and Local Anesthetic Mixture, run by Cairo University at 1 site in Egypt.
Trial summary
Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal,epidural, caudal anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration of postoperative analgesia. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nalbuphine,Fentanyl and Local Anesthetic Mixture
- What is being tested?
- Nalbuphine Group and Fentanyl Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2019to 18 May 2019
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged 40-70 years.
- both sex.
- ASA physical status Ι\&II.
- Patient with axial globe length below 26
Who cannot join
- Refusal of the patient to participate in the study.
- Coagulation abnormalities(INR>1.4).
- More than ASA II.
- High myopia with axial length more than 26 mm.
- Mentally retarded patients and failure of proper communication as in deafness .
- Morbidly obese patients(BMI>35)
- Patients with glaucoma (increased IOP>20mmgh)
- Patients with history of hypersensitivity to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture for Peribulbar Block During Posterior Segment Surgery in Adult Patients a Prospective Randomized Clinical Trial
Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal,epidural, caudal anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration of postoperative analgesia. The aim of this study is evaluation of the effect of 4 mg Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl 20 μg to LAM and LAM alone
Read the detailed description
120 patients (40 in each group) scheduled for elective posterior chamber surgery using peribulbar block. Patients of Group N received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group F received 6 ml of 0.5% bupivacaine 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 20 μg fentanyl in 1 ml saline (total 8 ml) and Group C received 6 ml of 0.5% bupivacaine,1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).
Study outcomes included evaluation and scoring (onset and duration) of eyelid and globe akinesia, total 15-min akinesia score and duration of block.
Intraoperative hemodynamic measures were measured every 15 minutes during the whole procedure and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was hourly-assessed using Visual Analogue Score (VAS) and analgesia was provided at VAS of >5.
Anesthetic procedure After securing intravenous access, non-invasive monitoring for blood pressure (SBP, DBP, MAP), E.C.G, and pulse oximetry (SpO2) were applied. tetracaine eye drops 0.5% applied to all patients as topical anesthesia. All patients were sedated using midazolam (0.05 mg/kg) as a preanesthetic medication I.V prior to receive LAM injection with nasal oxygen mask. Two ml of lidocaine 2% were diluted with 8 ml saline 3ml of LAM assigned for each group was injected in the medial canthus (the tunnel between the caruncle and the medial canthal angle) using needle 3-cm length and 27G inserted at angle of 45° between the caruncle and medial canthal angle till the tip of the needle touch the ethmoid bone then the direction of the needle was changed to 90° with the hub of the needle at level of the iris. Another 5 ml of LAM was injected at the extreme inferotemporal border of the orbit with the same needle directed downward and medially below the globe. Light orbital compression applied for 1 minute; then eye was evaluated 1, 3, 5 and 10 minutes for appearance of proptosis and chemosis.
All patients receive intraoperative non-invasive monitoring for blood pressure measures (SBP, DBP, MAP),E.C.G, and pulse oximetry (SpO2) prior to local anesthetic injection.
- Being tested
- Nalbuphine Group, Fentanyl Group, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine GroupDrug
Also called Group N
All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline
Fentanyl GroupDrug
Also called Group F
All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline
Control GroupDrug
Also called Group C
All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
Patients were categorized into three groups according to the type of additive used with the LAM as follows:
Group C (Control group): included patients assigned to receive 1 ml normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine Group | Active comparator | Nalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine Receives: Drug: Nalbuphine Group |
| Fentanyl Group | Active comparator | Fentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl Receives: Drug: Fentanyl Group |
| Control group | Active comparator | Control group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline Receives: Drug: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of eyelid and globe akinesia
The onset of eyelid and globe akinesia was assessed till complete recovery
Measured: 24 hours Postoperative
Secondary outcomes (3)
Blood pressure
Blood pressure (mmHg) .Hypotension is defined as a 20% decrease in MAP in relation to baseline measures
Measured: 24 hours Postoperative
Heart rate
Heart rate (beat/minute).Bradycardia were defined as a 20% decrease in HR in relation to baseline measures
Measured: 24 hours Postoperative
Post Operative analgesia
Assessed by using 11-points Visual Analogue Score (VAS) every hour for 6-hrs PO and was scored as 0 if no pain up to 10 which indicates sever pain sensation. PO analgesia was provided as if VAS was >5 in the form of I.M injection of pethidine50 mg
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start5 Feb 2019
- Primary completion10 May 2019
- Study completion18 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nalbuphine,Fentanyl and Local Anesthetic MixtureStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ahmed Abdalla Mohamed, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824665
- Sponsor's protocol ID
- Nalbuphine Versus Fentanyl
- Status last verified
- May 2019
- First submitted
- 19 Jan 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till Press
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalbuphine, Fentanyl and no Additive to Local Anaesthetic Mixture for Peribulbar Block During Posterior Segment Surgery in Adult Patients a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03824665
- Acronym / sponsor ID
- Nalbuphine Versus Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 18 May 2019 (actual)
- First posted
- 31 Jan 2019 (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.
Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal,epidural, caudal anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration of postoperative analgesia. The aim of this study is evaluation of the effect of 4 mg Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl 20 μg to LAM and LAM alone
Detailed description
120 patients (40 in each group) scheduled for elective posterior chamber surgery using peribulbar block. Patients of Group N received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group F received 6 ml of 0.5% bupivacaine 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 20 μg fentanyl in 1 ml saline (total 8 ml) and Group C received 6 ml of 0.5% bupivacaine,1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).
Study outcomes included evaluation and scoring (onset and duration) of eyelid and globe akinesia, total 15-min akinesia score and duration of block.
Intraoperative hemodynamic measures were measured every 15 minutes during the whole procedure and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was hourly-assessed using Visual Analogue Score (VAS) and analgesia was provided at VAS of >5.
Anesthetic procedure After securing intravenous access, non-invasive monitoring for blood pressure (SBP, DBP, MAP), E.C.G, and pulse oximetry (SpO2) were applied. tetracaine eye drops 0.5% applied to all patients as topical anesthesia. All patients were sedated using midazolam (0.05 mg/kg) as a preanesthetic medication I.V prior to receive LAM injection with nasal oxygen mask. Two ml of lidocaine 2% were diluted with 8 ml saline 3ml of LAM assigned for each group was injected in the medial canthus (the tunnel between the caruncle and the medial canthal angle) using needle 3-cm length and 27G inserted at angle of 45° between the caruncle and medial canthal angle till the tip of the needle touch the ethmoid bone then the direction of the needle was changed to 90° with the hub of the needle at level of the iris. Another 5 ml of LAM was injected at the extreme inferotemporal border of the orbit with the same needle directed downward and medially below the globe. Light orbital compression applied for 1 minute; then eye was evaluated 1, 3, 5 and 10 minutes for appearance of proptosis and chemosis.
All patients receive intraoperative non-invasive monitoring for blood pressure measures (SBP, DBP, MAP),E.C.G, and pulse oximetry (SpO2) prior to local anesthetic injection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Evaluation of the analgesic and hemodynamic outcome of nalbuphine or fentanyl versus a control group for peribulbar block (PBB) during posterior chamber surgery.
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine Group | Active comparator | Drug: Nalbuphine GroupNalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine |
| Fentanyl Group | Active comparator | Drug: Fentanyl GroupFentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl |
| Control group | Active comparator | Drug: Control GroupControl group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged 40-70 years.
- both sex.
- ASA physical status Ι\&II.
- Patient with axial globe length below 26
Key exclusion criteria (8 listed)
- Refusal of the patient to participate in the study.
- Coagulation abnormalities(INR>1.4).
- More than ASA II.
- High myopia with axial length more than 26 mm.
- Mentally retarded patients and failure of proper communication as in deafness .
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 |
|---|---|---|
| Nalbuphine GroupAlso: Group NAll patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline | Drug | Nalbuphine Group |
| Fentanyl GroupAlso: Group FAll patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline | Drug | Fentanyl Group |
| Control GroupAlso: Group CAll patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group C (Control group): included patients assigned to receive 1 ml normal saline. | Drug | Control group |
Primary outcome
Onset of eyelid and globe akinesia
Time frame: 24 hours Postoperative
The onset of eyelid and globe akinesia was assessed till complete recovery
3 secondary outcomes
Blood pressure
Time frame: 24 hours Postoperative
Heart rate
Time frame: 24 hours Postoperative
Post Operative analgesia
Time frame: 24 hours Postoperative
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 21 May 2019.
- Individual participant dataSharing planned: Undecided. Till Press
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.
Ahmed Abdalla Mohamed, M.D principal investigator
Cairo University
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 Nalbuphine Group and Fentanyl Group in people with Nalbuphine,Fentanyl and Local Anesthetic Mixture, 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 4 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 21 May 2019. 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 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?
Onset of eyelid and globe akinesia (time frame: 24 hours Postoperative). 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 21 May 2019.