- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04610307
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA
October 30, 2020 updated by: Dr Anum Arif, Combined Military Hospital, Pakistan
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
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lahore, Pakistan, 0092
- Combined Military Hospital
-
Contact:
- Email: dranumarif@yahoo.com
-
Principal Investigator:
- Anum Arif, MBBS FCPS
-
Sub-Investigator:
- Brig Ahsin Manzoor Bhatti, MBBS FCPS FRCS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I to III
- Brachiocephalic arteriovenous fistula
- Radiocephalic arteriovenous fistula
Exclusion Criteria:
- basiic vein transposition
- redo surgery emergency surgery
- failure to understand the questionnnare
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: control group
patients receiving 1 % plain xylocaine
|
patients will undergo surgery under buffered local anesthesia
|
EXPERIMENTAL: intervention group
patients receiving buffered 1 % xylocaine
|
patients will undergo surgery under buffered local anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2020
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
December 1, 2020
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (ACTUAL)
October 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 3, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMHLahore
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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