Shoulder PainNCT04284007
Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine
A study testing Perineural levobupivacaine, Perineural dexamethasone in addition to levobupivacaine and Intravenous dexamethasone with perineural levobupivacaine in people with Shoulder Pain, run by Mansoura University at 1 site in Egypt.
Trial summary
Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management. The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Perineural levobupivacaine, Perineural dexamethasone in addition to levobupivacaine and Intravenous dexamethasone with perineural levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2019to Dec 2020
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status grade I and grade II.
Who cannot join
- Patient refusal.
- Neuromuscular diseases (as myopathies, myasthenia gravies, …...)
- Hematological diseases, bleeding or coagulation abnormality.
- Psychiatric diseases.
- Local skin infection
- Sepsis at site of the block.
Show all 12Show fewer
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2
- contralateral phrenic palsy
- pneumothorax
- pneumectomy
- severe COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries
Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
Read the detailed description
Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.
- Conditions
- Shoulder Pain
- Being tested
- Perineural levobupivacaine, Perineural dexamethasone in addition to levobupivacaine, Intravenous dexamethasone with perineural levobupivacaine
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural levobupivacaineDrug
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
Perineural dexamethasone in addition to levobupivacaineDrug
Patients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
Intravenous dexamethasone with perineural levobupivacaineDrug
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline.
| Study group | Role | What they receive |
|---|---|---|
| Perineural levobupivacaine with intravenous saline | Active comparator | Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline. Receives: Drug: Perineural levobupivacaine |
| Perineural dexamethasone in addition to levobupivacaine | Experimental | Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline. Receives: Drug: Perineural dexamethasone in addition to levobupivacaine |
| Intravenous dexamethasone with perineural levobupivacaine | Experimental | Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone. Receives: Drug: Intravenous dexamethasone with perineural levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia
as measured by time to first analgesic requirement.
Measured: for 24 hour postoperatively
Secondary outcomes (13)
Onset of Sensory block
Patients will be closely observed until 30 minutes after the end of local anesthetic injection. Block success will be defined as loss of sensation to pinprick in the C4 and C5 sensory dermatome distribution measured 30 minutes after the end of local anesthetic injection. sensory block will be assessed by pin prick test using a 3point scale: • Grade 0 = Normal sensation.
- Grade 1 = loss of sensation to pin prick (analgesia).
- Grade 2 = loss of sensation to touch (anaesthesia). Onset time for sensory block will be defined as the time interval between the end of local anaesthesia administration and complete sensory block (score 2).
Measured: For 30 min after injecting local anesthetic
Duration of sensory block
defined as the time interval between complete sensory block (score 2) and complete resolution of anaesthesia on all nerves (score 0)
Measured: within 24 hours after the surgery.
Onset time of motor block
Motor block will be determined according to the modified Bromage scale:
- Grade 0 = Normal motor function with full flexion and extention of elbow.
- Grade 1 = Decrease motor power.
- Grade 2 = Complete motor block. Onset time of motor block will be defined as the time interval between end of local anaesthetic administration and complete motor block (grade 2).
Measured: For 30 min after injecting local anesthic
Duration of motor block
defined as the time interval between complete motor block (score 2) and complete recovery of motor function of the arm (score 0).
Measured: within 24 hours after the surge
Intraoperative Heart rate changes
Heart rate changes
Measured: For 3 hours after surgery
Intraoperative Mean arterial blood pressure changes
Mean arterial blood pressure changes
Measured: For 3 hours after surgery
Intraoperative analgesic consumption
the intraoperative analgesic dose consumption would be calculated The investigators can use fentanyl as analgesic if the patient required during the surgery ( 50-100 mic)
Measured: For 3 hours after surgery
Postoperative heart rate changes
Measured: For one hour after admission to the postoperative anesthesia care unit
Postoperative Mean arterial blood pressure changes
Measured: For one hour after admission to the postoperative anesthesia care unit
Postoperative peripheral oxygen saturation changes
Measured: For one hour after admission to the postoperative anesthesia care unit
Pain score
The VAS is represented with straight line with one end has the anchor " no pain" and it takes 0, while the other end of the line has the anchor " pain as bad as it could be" and it takes 10.
The patient will receive the rescue analgesic when the score is more than 4)
Measured: Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.
Total analgesic need and the onset of first intravenous analgesia
Total analgesic need to rescue analgesic (pethidine) calculated by mg. And the onset of time for first intravenous analgesia during the 24 hours postoperative by hours.
Measured: After transportation of the patient from PACU up to 24 hours postoperative.
Patient satisfaction: 2-point scale
concerning the procedure is assessed using a 2-point scale (1= satisfied, I would want the same anesthesia / analgesia method for the next surgery, 2= unsatisfied, I would want a different anesthesia / analgesia method for the next surgery).
Measured: first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start2 Dec 2019
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nahla S El-Ebahnsawy, MD, Study chair, Professor of Anesthesia and Surgical Intensive CareHazem E Moawed, MD, Study director, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284007
- Sponsor's protocol ID
- MFM_IRB, MS.18.03.65 -
- Status last verified
- Feb 2020
- First submitted
- 28 Dec 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries
- ClinicalTrials.gov ID
- NCT04284007
- Acronym / sponsor ID
- MFM_IRB, MS.18.03.65 -
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Feb 2020 (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.
Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
Detailed description
Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perineural levobupivacaine with intravenous saline | Active comparator | Drug: Perineural levobupivacainePatients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline. |
| Perineural dexamethasone in addition to levobupivacaine | Experimental | Drug: Perineural dexamethasone in addition to levobupivacainePatients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline. |
| Intravenous dexamethasone with perineural levobupivacaine | Experimental | Drug: Intravenous dexamethasone with perineural levobupivacainePatients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status grade I and grade II.
Key exclusion criteria (12 listed)
- Patient refusal.
- Neuromuscular diseases (as myopathies, myasthenia gravies, …...)
- Hematological diseases, bleeding or coagulation abnormality.
- Psychiatric diseases.
- Local skin infection
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 |
|---|---|---|
| Perineural levobupivacainePatients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline. | Drug | Perineural levobupivacaine with intravenous saline |
| Perineural dexamethasone in addition to levobupivacainePatients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline. | Drug | Perineural dexamethasone in addition to levobupivacaine |
| Intravenous dexamethasone with perineural levobupivacainePatients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline. | Drug | Intravenous dexamethasone with perineural levobupivacaine |
Primary outcome
Duration of postoperative analgesia
Time frame: for 24 hour postoperatively
as measured by time to first analgesic requirement.
13 secondary outcomes
Onset of Sensory block
Time frame: For 30 min after injecting local anesthetic
Duration of sensory block
Time frame: within 24 hours after the surgery.
Onset time of motor block
Time frame: For 30 min after injecting local anesthic
Duration of motor block
Time frame: within 24 hours after the surge
Intraoperative Heart rate changes
Time frame: For 3 hours after surgery
Intraoperative Mean arterial blood pressure changes
Time frame: For 3 hours after surgery
Intraoperative analgesic consumption
Time frame: For 3 hours after surgery
Postoperative heart rate changes
Time frame: For one hour after admission to the postoperative anesthesia care unit
Postoperative Mean arterial blood pressure changes
Time frame: For one hour after admission to the postoperative anesthesia care unit
Postoperative peripheral oxygen saturation changes
Time frame: For one hour after admission to the postoperative anesthesia care unit
Pain score
Time frame: Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.
Total analgesic need and the onset of first intravenous analgesia
Time frame: After transportation of the patient from PACU up to 24 hours postoperative.
Patient satisfaction: 2-point scale
Time frame: first 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Yes. The raw data
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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.
Nahla S El-Ebahnsawy, MD study chair
Professor of Anesthesia and Surgical Intensive Care
Hazem E Moawed, MD study director
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineural levobupivacaine, Perineural dexamethasone in addition to levobupivacaine and Intravenous dexamethasone with perineural levobupivacaine in people with Shoulder Pain, run by Mansoura 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 1 inclusion and 12 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 25 Feb 2020. 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?
Results are not available in the source record.
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?
Duration of postoperative analgesia (time frame: for 24 hour postoperatively). 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 25 Feb 2020.