Pain, ProceduralNCT04610307
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA
A study testing buffered anesthesia in people with Pain, Procedural and Pain, Postoperative, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural, Pain, Postoperative, Satisfaction, Patient
- What is being tested?
- buffered anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2020to 1 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I to III
- Brachiocephalic arteriovenous fistula
- Radiocephalic arteriovenous fistula
Who cannot join
- basiic vein transposition
- redo surgery emergency surgery
- failure to understand the questionnnare
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Combined Military Hospital
Lahore, 0092
Anum Arif, MBBS FCPS, 03422398424, dranumarif@yahoo.com
dranumarif@yahoo.com
About this study
Official title: EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN DURING ARTERIOVEONUS FISTULA
Pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups
Read the detailed description
All patients meeting inclusion criteria will be randomly enrolled in two groups. Intervention group will receive buffered lignocaine . at the end of procedure data will be recorded regarding pain VASscore and satisfaction score
- Conditions
- Pain, Procedural, Pain, Postoperative, Satisfaction, Patient
- Being tested
- buffered anesthesia
- Medical subject headings
- Pain, Procedural, Pain, Postoperative, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buffered anesthesiaProcedure or surgery
patients will undergo surgery under buffered local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | patients receiving 1 % plain xylocaine Receives: Procedure: buffered anesthesia |
| intervention group | Experimental | patients receiving buffered 1 % xylocaine Receives: Procedure: buffered anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
pain score on visual analog score on a scale of 0 to 10. 0 means no pain. 1 is least pain and 10 is maximum pain
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anum Arif, Combined Military Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610307
- Sponsor's protocol ID
- CMHLahore
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN DURING ARTERIOVEONUS FISTULA
- ClinicalTrials.gov ID
- NCT04610307
- Acronym / sponsor ID
- CMHLahore
- Conditions
- Pain, Procedural, Pain, Postoperative, Satisfaction, Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 30 Oct 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.
Pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups
Detailed description
All patients meeting inclusion criteria will be randomly enrolled in two groups. Intervention group will receive buffered lignocaine . at the end of procedure data will be recorded regarding pain VASscore and satisfaction score
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: buffered anesthesiapatients receiving 1 % plain xylocaine |
| intervention group | Experimental | Procedure: buffered anesthesiapatients receiving buffered 1 % xylocaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I to III
- Brachiocephalic arteriovenous fistula
- Radiocephalic arteriovenous fistula
Key exclusion criteria (3 listed)
- basiic vein transposition
- redo surgery emergency surgery
- failure to understand the questionnnare
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 |
|---|---|---|
| buffered anesthesiapatients will undergo surgery under buffered local anesthesia | Procedure or surgery | control group, intervention group |
Primary outcome
pain score
Time frame: 60 minutes
pain score on visual analog score on a scale of 0 to 10. 0 means no pain. 1 is least pain and 10 is maximum pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing buffered anesthesia in people with Pain, Procedural and Pain, Postoperative, run by Combined Military Hospital, Pakistan 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 3 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 3 Nov 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 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.
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 Anum Arif (+923422398424, dranumarif@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 60 minutes). 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 3 Nov 2020.