PainPhase 3NCT06717672
Effect of Lidocaine in Reducing Opioids Requirement in Day Care Surgery
A Phase 3 study testing Lidocaine 2% without vessel constrictor and Normal Saline in people with Pain and Post-operative Pain Control, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
1. *Reduced opioid consumption 2. *Decreased pain scores 3. *Fewer opioid-related side effects 4. *Improved patient satisfaction Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Post-operative Pain Control, Post-operative Pain
- What is being tested?
- Lidocaine 2% without vessel constrictor and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2023to 10 May 2024
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1 and 2
- patient age between 18 and 65 years
- Patient undergoing ambulatory surgeries
Who cannot join
- Pregnant women
- Allergic to Lidocaine Patient who had fever and treated with antibiotic and steroid in last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lidocaine in Decreasing Perioperative Analgesic Opioids Requirement After Ambulatory Surgery
- *Reduced opioid consumption
- *Decreased pain scores
- *Fewer opioid-related side effects
- *Improved patient satisfaction
Read the detailed description
Studies have shown that lidocaine can reduce opioid consumption by 20-50% in the perioperative period.
Studies have shown that lidocaine can reduce opioid consumption by 20-50% in the perioperative period.
By reducing opioid consumption, lidocaine can also decrease the incidence of opioid-related side effects, such as nausea, vomiting, and respiratory depression.
Lidocaine's analgesic effects can improve patient satisfaction and reduce anxiety related to pain
- Conditions
- Pain, Post-operative Pain Control, Post-operative Pain
- Being tested
- Lidocaine 2% without vessel constrictor, Normal Saline
- Keywords
- Lidocaine, Opiods, Peri-operative pain, Decrease Opioid requirement, Ambulatory surgeries
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% without vessel constrictorDrug
- _Lidocaine 2% provides rapid and effective local anesthesia for minor surgical procedures, such as biopsies, excisions, and suturing.
- _Pain relief_: Lidocaine 2% has been shown to provide significant pain relief in patients with acute pain, such as post-operative pain, trauma, and burns.
- _Reducing pain intensity_: Lidocaine 2% has been shown to reduce pain intensity by 30-50% in various clinical studies.
Normal SalineDrug
Normal saline used is an iv fluid given for fluid replacement
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | intervention group recieve inj lidocaine Receives: Drug: Lidocaine 2% without vessel constrictor |
| Control group | Placebo comparator | control group receive Normal saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative pain
Visual Analog pain scale to rate pain scale comprises 0 to 10 score 0 minimum to 10 Maximum
Measured: at 2 hours, 4 hours, 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start5 Nov 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanesh Tanwani, Liaquat National Hospital & Medical College
- Investigators
- Hanesh Tanwani Dr Hanesh Tanwani, Principal investigator, Liaquat National Hospital and Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717672
- Sponsor's protocol ID
- ANS-2021-192-2750
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: \*Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. Patient confidentiality\*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lidocaine in Decreasing Perioperative Analgesic Opioids Requirement After Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT06717672
- Acronym / sponsor ID
- ANS-2021-192-2750
- Conditions
- Pain, Post-operative Pain Control, Post-operative Pain
- Keywords
- Lidocaine, Opiods, Peri-operative pain, Decrease Opioid requirement, Ambulatory surgeries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 5 Dec 2024 (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.
- *Reduced opioid consumption
- *Decreased pain scores
- *Fewer opioid-related side effects
- *Improved patient satisfaction
Detailed description
Studies have shown that lidocaine can reduce opioid consumption by 20-50% in the perioperative period.
Studies have shown that lidocaine can reduce opioid consumption by 20-50% in the perioperative period.
By reducing opioid consumption, lidocaine can also decrease the incidence of opioid-related side effects, such as nausea, vomiting, and respiratory depression.
Lidocaine's analgesic effects can improve patient satisfaction and reduce anxiety related to pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Lidocaine 2% without vessel constrictorintervention group recieve inj lidocaine |
| Control group | Placebo comparator | Drug: Normal Salinecontrol group receive Normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1 and 2
- patient age between 18 and 65 years
- Patient undergoing ambulatory surgeries
Key exclusion criteria (2 listed)
- Pregnant women
- Allergic to Lidocaine Patient who had fever and treated with antibiotic and steroid in last month
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 2% without vessel constrictor1. _Lidocaine 2% provides rapid and effective local anesthesia for minor surgical procedures, such as biopsies, excisions, and suturing. 2. _Pain relief_: Lidocaine 2% has been shown to provide significant pain relief in patients with acute pain, such as post-operative pain, trauma, and burns. 3. _Reducing pain intensity_: Lidocaine 2% has been shown to reduce pain intensity by 30-50% in various clinical studies. | Drug | Intervention group |
| Normal SalineNormal saline used is an iv fluid given for fluid replacement | Drug | Control group |
Primary outcome
Peri-operative pain
Time frame: at 2 hours, 4 hours, 6 hours
Visual Analog pain scale to rate pain scale comprises 0 to 10 score 0 minimum to 10 Maximum
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 10 Dec 2024.
- Systemic lidocaine decreased the perioperative opioid analgesic requirements but failed to reduce discharge time after ambulatory surgery Allannah McKay 1, Antje Gottschalk, Annette Ploppa, Marcel E Durieux, Danja S GrovesLink provided by the sponsor.
- Individual participant dataSharing planned: No. *Informed consent*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. Patient confidentiality*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families.
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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.
Hanesh Tanwani Dr Hanesh Tanwani principal investigator
Liaquat National Hospital and Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine 2% without vessel constrictor and Normal Saline in people with Pain and Post-operative Pain Control, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 3 inclusion and 2 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 10 Dec 2024. 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 Pakistan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Peri-operative pain (time frame: at 2 hours, 4 hours, 6 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 10 Dec 2024.