Postoperative PainNCT05624957
Lidocaine Irrigation in Shoulder Arthroscopy
A study testing Lidocaine epinephrine and Epinephrin in people with Postoperative Pain and Analgesia, run by Minia University at 1 site in Egypt.
Trial summary
Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Analgesia
- What is being tested?
- Lidocaine epinephrine and Epinephrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2022to 1 Aug 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-60
- Both genders
- Shoulder arthroscopy
- ASA I-III
Who cannot join
- Drug allergy
- Psychiatric disorder
- Opioid dependence
- Liver disease
- Patient refuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study
Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid.
The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.
- Conditions
- Postoperative Pain, Analgesia
- Being tested
- Lidocaine epinephrine, Epinephrin
- Keywords
- Postoperative pain, Lidocaine, Shoulder arthroscopy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine epinephrineDrug
Under aseptic condition every one litre of fluid irrigation will be mixture with 10 ml of lidocaine 2% and 0.25mg epinephrine and the last one use before end of surgery dexamethasone 8 mg will be added.
EpinephrinDrug
0.25 mg epinephrine mixed with one litre of fluid irrigation
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | The patients will undergo shoulder arthroscopy with lidocaine epinephrine fluids irrigation. Receives: Drug: Lidocaine epinephrine |
| control group | Placebo comparator | The patients will undergo shoulder arthroscopy with epinephrine fluids irrigation only. Receives: Drug: Epinephrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
total analgesic consumption
total nalbuphine consumed one day after surgery
Measured: 24 hours
Secondary outcomes (2)
first analgesic request
time of PCA request
Measured: 24 hours
Visual analogue pain score
pain intensity at rest and movement from 0-10 which 0 no pain and 10 the worst pain
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 posted22 Nov 2022
- Study start25 Nov 2022
- Primary completion1 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mokhtar Elshorbagy Hetta, Minia University
- Investigators
- hassan m. hetta, lecturer, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624957
- Sponsor's protocol ID
- 475:10/2022
- Status last verified
- Oct 2023
- First submitted
- 3 Nov 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05624957
- Acronym / sponsor ID
- 475:10/2022
- Conditions
- Postoperative Pain, Analgesia
- Keywords
- Postoperative pain, Lidocaine, Shoulder arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 22 Nov 2022 (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.
Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid.
The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: Lidocaine epinephrineThe patients will undergo shoulder arthroscopy with lidocaine epinephrine fluids irrigation. |
| control group | Placebo comparator | Drug: EpinephrinThe patients will undergo shoulder arthroscopy with epinephrine fluids irrigation only. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-60
- Both genders
- Shoulder arthroscopy
- ASA I-III
Key exclusion criteria (5 listed)
- Drug allergy
- Psychiatric disorder
- Opioid dependence
- Liver disease
- Patient refuse
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 |
|---|---|---|
| Lidocaine epinephrineUnder aseptic condition every one litre of fluid irrigation will be mixture with 10 ml of lidocaine 2% and 0.25mg epinephrine and the last one use before end of surgery dexamethasone 8 mg will be added. | Drug | lidocaine |
| Epinephrin0.25 mg epinephrine mixed with one litre of fluid irrigation | Drug | control group |
Primary outcome
total analgesic consumption
Time frame: 24 hours
total nalbuphine consumed one day after surgery
2 secondary outcomes
first analgesic request
Time frame: 24 hours
Visual analogue pain score
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 19 Oct 2023.
- Individual participant dataSharing planned: No
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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.
hassan m. hetta, lecturer principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine epinephrine and Epinephrin in people with Postoperative Pain and Analgesia, run by Minia 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 5 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 19 Oct 2023. 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.
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?
total analgesic consumption (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 19 Oct 2023.