Rotator Cuff TearPhase 2NCT03034382
Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries
A Phase 2 study testing Morphine, Nalbuphine and Bupivacaine 0.5% in people with Rotator Cuff Tear, run by Assiut University at 1 site in Egypt.
Trial summary
the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Morphine, Nalbuphine and Bupivacaine 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jun 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
- ASA physical status I - Ш.
Who cannot join
- Infection at the site of injection.
- Coagulopathy or other bleeding diathesis.
- Known allergy to drugs in the study
- Preexisting neurologic deficits in the area to be blocked.
- Inability to communicate with the investigator and the hospital staff.
- History of chronic opioid use.
- Morbid obesity BMI>40.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals
Asyut, 71515
Ayman A Mamdouh, AssProf, 01066066001 ext. 002, aymanosman2000@yahoo.com
About this study
Official title: Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine
the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.
- Conditions
- Rotator Cuff Tear
- Being tested
- Morphine, Nalbuphine, Bupivacaine 0.5%, Lidocaine Hydrochloride 1% and epinephrine 1:400,000
- Keywords
- morphine, nalbuphine, arthroscopic rotator cuff repair, ultrasound guided interscalene block
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called morphine sulphate
5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
NalbuphineDrug
Also called nubain
5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Bupivacaine 0.5%Drug
Also called Marcaine HCL
10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block
Lidocaine Hydrochloride 1% and epinephrine 1:400,000Drug
Also called lidocaine HCL and Adrenaline
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Experimental | 5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. Receives: Drug: Morphine; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000 |
| Nalbuphine | Experimental | 5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. Receives: Drug: Nalbuphine; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000 |
| Morphine and Nalbuphine | Experimental | 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block Receives: Drug: Morphine; Drug: Nalbuphine; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000 |
| Bupivacaine 0.5% | Placebo comparator | 10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block. Receives: Drug: Bupivacaine 0.5%; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total number of analgesic requests
the combination of opioid agonist and mixed agonist-antagonist peripherally prevents the development of early tolerance of the opioid agonist; thus the agonist would maintain the same efficacy and this will be obvious clinically by a reduction in the requests for supplementary analgesia.
Measured: 72 hours postoperative followup
Secondary outcomes (6)
duration of analgesia
duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.
Measured: 72 hours followup
patient satisfaction
- The patient satisfaction score. Patients were also asked to rate their satisfaction with the analgesia on a scale of 0-10 (0 for total dissatisfaction to 10 for total satisfaction).
Measured: 72 hours followup
The first time to ask for analgesics
Measured: 72 hours followup
sedation score
recorded every 4 hours; ranging from alert, drowsy, sleeping but responsive to verbal commands up to unarousable (we consider sedation score 3 or more as clinically significant sedation that mandate close patient observation every hour).
Measured: 72 hours followup
number of vomiting attacks
recorded every 4 hours. A vomiting attack was defined by events of vomiting that occurred in a rapid sequence (<1 minute between events). If vomiting was separated by more than 1 minute; they will be considered to be separate attacks. Retching (the same as vomiting but without expulsion of gastric contents) was considered as vomiting. If the patient experienced vomiting; ondansetron 4 mg IV was given.
Measured: 72 hours followup
itching
Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).
Measured: 72 hours followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Abbas Hassan, Assiut University
- Investigators
- Mahmoud A Aly, Prof, Study chair, Assiut University HospitalsKawser H Mohammed, Prof, Study chair, Assiut University HospitalsAyman A Mamdouh, Ass Prof, Study director, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034382
- Sponsor's protocol ID
- SH1
- Status last verified
- May 2017
- First submitted
- 19 Jan 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine
- ClinicalTrials.gov ID
- NCT03034382
- Acronym / sponsor ID
- SH1
- Conditions
- Rotator Cuff Tear
- Keywords
- morphine, nalbuphine, arthroscopic rotator cuff repair, ultrasound guided interscalene block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 27 Jan 2017 (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 aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Morphine | Experimental | Drug: Morphine, Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,0005 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. |
| Nalbuphine | Experimental | Drug: Nalbuphine, Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,0005 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. |
| Morphine and Nalbuphine | Experimental | Drug: Morphine, Drug: Nalbuphine, Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,0005 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block |
| Bupivacaine 0.5% | Placebo comparator | Drug: Bupivacaine 0.5%, Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,00010 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
- ASA physical status I - Ш.
Key exclusion criteria (7 listed)
- Infection at the site of injection.
- Coagulopathy or other bleeding diathesis.
- Known allergy to drugs in the study
- Preexisting neurologic deficits in the area to be blocked.
- Inability to communicate with the investigator and the hospital staff.
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 |
|---|---|---|
| MorphineAlso: morphine sulphate5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block | Drug | Morphine, Morphine and Nalbuphine |
| NalbuphineAlso: nubain5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block | Drug | Morphine and Nalbuphine, Nalbuphine |
| Bupivacaine 0.5%Also: Marcaine HCL10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block | Drug | Bupivacaine 0.5% |
| Lidocaine Hydrochloride 1% and epinephrine 1:400,000Also: lidocaine HCL and Adrenaline10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block | Drug | Bupivacaine 0.5%, Morphine, Morphine and Nalbuphine, Nalbuphine |
Primary outcome
the total number of analgesic requests
Time frame: 72 hours postoperative followup
the combination of opioid agonist and mixed agonist-antagonist peripherally prevents the development of early tolerance of the opioid agonist; thus the agonist would maintain the same efficacy and this will be obvious clinically by a reduction in the requests for supplementary analgesia.
6 secondary outcomes
duration of analgesia
Time frame: 72 hours followup
patient satisfaction
Time frame: 72 hours followup
The first time to ask for analgesics
Time frame: 72 hours followup
sedation score
Time frame: 72 hours followup
number of vomiting attacks
Time frame: 72 hours followup
itching
Time frame: 72 hours followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud A Aly, Prof study chair
Assiut University Hospitals
Kawser H Mohammed, Prof study chair
Assiut University Hospitals
Ayman A Mamdouh, Ass Prof study director
Assiut University Hospitals
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 Morphine, Nalbuphine and Bupivacaine 0.5% in people with Rotator Cuff Tear, 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 2 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: status not confirmed, as of the sponsor's last update on 22 May 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa A Husien, Msc (01002953253 ext. 002, shimo.9feb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total number of analgesic requests (time frame: 72 hours postoperative followup). 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 22 May 2017.