Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract SurgeryNCT03436836
Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery
A study testing Nalbuphine, lidocaine, bupivacaine, hyaluronidase , saline and lidocaine, bupivacaine , hyaluronidase in people with Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery, run by Cairo University at 2 sites 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.The aim of this study is evaluation of the effect of nalbuphine when used as an adjuvant to a local anesthetic… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery
- What is being tested?
- Nalbuphine, lidocaine, bupivacaine, hyaluronidase , saline and lidocaine, bupivacaine , hyaluronidase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 14 Jan 2018to 28 Feb 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients aged 40-60 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
2 sites in 1 country.
About this study
Official title: Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery a Randomized Controlled Study
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 nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing cataract surgery
Read the detailed description
44 patients (22 in each group) scheduled for elective cataract surgery using peribulbar block. Patients of Group N received local anesthetics 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 C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).
Addition of nalbuphine to bupivacaine in peribulbar block is associated with reduced the time of onset of globe akinesia, increased the duration of globe akinesia and analgesia with better postoperative pain relief
- Being tested
- Nalbuphine, lidocaine, bupivacaine, hyaluronidase , saline, lidocaine, bupivacaine , hyaluronidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Both groups received 8 ml solution for the peribulbar block, Patients of group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)(16) and 4mg of nalbuphine in 1 ml normal saline. Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe.
If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study.
After adequate analgesia (loss of sensation to touch by a small cotton wool) and akinesia, the surgeon was allowed to start the surgery
lidocaine, bupivacaine, hyaluronidase , salineDrug
lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).
lidocaine, bupivacaine , hyaluronidaseDrug
2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)
| Study group | Role | What they receive |
|---|---|---|
| Group N | Experimental | group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU) and 4mg of nalbuphine in 1 ml normal saline.
Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study Receives: Drug: Nalbuphine; Drug: lidocaine, bupivacaine , hyaluronidase |
| Group C | Active comparator | Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline Receives: Drug: lidocaine, bupivacaine, hyaluronidase , saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block
Duration of the sensory block
Measured: 12 hours Postoperative
Secondary outcomes (5)
Motor block
Duration of the motor block
Measured: 12 hours Postoperative
Sensory block onset
Onset of the sensory block
Measured: 12 hours Postoperative
Mean Arterial blood pressure
Hemodynamic parameter as mean blood pressure(mmHg)
Measured: 24 hours postoperatively
Adverse effects of the used drugs
Adverse effects of the used drugs as nausea and vomiting
Measured: 24 hours postoperatively
Satisfaction assessed at the end of surgical procedure by using a three-point scale
Patient satisfaction and surgeon satisfaction
Measured: 6 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start14 Jan 2018
- Primary completion20 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract SurgeryStudies 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
- Forty-four patients were enrolled in the current study and randomly allocated into two equal groups \[Group N (n=22) and Group C (n=22)\]. Two patients in Group N and three patients in Group C were excluded from the study due to failure of the block to achieve satisfactory surgical condition (inadequate akinesia OMS\>2) so, received additional supplementations 2-3 ml of LA mixture and were excluded from the study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Nadia Yossif Helmy, Ahmed Elbadawy Mahmoud, Abdelhamid, Bassant Mohamed, M.D., Atef Kamel Salama, Mostafa Abdalwahab Elberry
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436836
- Sponsor's protocol ID
- N-93-2017
- Status last verified
- May 2018
- First submitted
- 30 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
- Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03436836
- Acronym / sponsor ID
- N-93-2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Nadia Yossif Helmy, Ahmed Elbadawy Mahmoud, Abdelhamid, Bassant Mohamed, M.D., Atef Kamel Salama, Mostafa Abdalwahab Elberry
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 19 Feb 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.
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 nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing cataract surgery
Detailed description
44 patients (22 in each group) scheduled for elective cataract surgery using peribulbar block. Patients of Group N received local anesthetics 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 C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).
Addition of nalbuphine to bupivacaine in peribulbar block is associated with reduced the time of onset of globe akinesia, increased the duration of globe akinesia and analgesia with better postoperative pain relief
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Forty-four patients were enrolled in the current study and randomly allocated into two equal groups [Group N (n=22) and Group C (n=22)]. Two patients in Group N and three patients in Group C were excluded from the study due to failure of the block to achieve satisfactory surgical condition (inadequate akinesia OMS>2) so, received additional supplementations 2-3 ml of LA mixture and were excluded from the study
| Arm | Type | Receives |
|---|---|---|
| Group N | Experimental | Drug: Nalbuphine, Drug: lidocaine, bupivacaine , hyaluronidasegroup N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU) and 4mg of nalbuphine in 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study |
| Group C | Active comparator | Drug: lidocaine, bupivacaine, hyaluronidase , salinePatients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients aged 40-60 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 |
|---|---|---|
| NalbuphineBoth groups received 8 ml solution for the peribulbar block, Patients of group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)(16) and 4mg of nalbuphine in 1 ml normal saline. Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study. After adequate analgesia (loss of sensation to touch by a small cotton wool) and akinesia, the surgeon was allowed to start the surgery | Drug | Group N |
| lidocaine, bupivacaine, hyaluronidase , salinelidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml). | Drug | Group C |
| lidocaine, bupivacaine , hyaluronidase2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU) | Drug | Group N |
Primary outcome
Sensory block
Time frame: 12 hours Postoperative
Duration of the sensory block
5 secondary outcomes
Motor block
Time frame: 12 hours Postoperative
Sensory block onset
Time frame: 12 hours Postoperative
Mean Arterial blood pressure
Time frame: 24 hours postoperatively
Adverse effects of the used drugs
Time frame: 24 hours postoperatively
Satisfaction assessed at the end of surgical procedure by using a three-point scale
Time frame: 6 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 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nalbuphine, lidocaine, bupivacaine, hyaluronidase , saline and lidocaine, bupivacaine , hyaluronidase in people with Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery, run by Cairo University at 2 sites 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 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 2 sites 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?
Sensory block (time frame: 12 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 30 May 2018.