Back to resultsEFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA
Primary Purpose
Pain, Procedural, Pain, Postoperative, Satisfaction, Patient
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
buffered anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Procedural
Eligibility Criteria
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
Sites / Locations
- Combined Military Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
intervention group
Arm Description
patients receiving 1 % plain xylocaine
patients receiving buffered 1 % xylocaine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04610307
First Posted
October 26, 2020
Last Updated
October 30, 2020
Sponsor
Combined Military Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT04610307
Brief Title
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA
Official Title
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN DURING ARTERIOVEONUS FISTULA
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural, Pain, Postoperative, Satisfaction, Patient
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
patients receiving 1 % plain xylocaine
Arm Title
intervention group
Arm Type
Experimental
Arm Description
patients receiving buffered 1 % xylocaine
Intervention Type
Procedure
Intervention Name(s)
buffered anesthesia
Intervention Description
patients will undergo surgery under buffered local anesthesia
Primary Outcome Measure Information:
Title
pain score
Description
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
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anum Arif
Phone
+923422398424
Email
dranumarif@yahoo.com
Facility Information:
Facility Name
Combined Military Hospital
City
Lahore
ZIP/Postal Code
0092
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anum Arif, MBBS FCPS
Phone
03422398424
Email
dranumarif@yahoo.com
Ext
Arif
Email
dranumarif@yahoo.com
First Name & Middle Initial & Last Name & Degree
Anum Arif, MBBS FCPS
First Name & Middle Initial & Last Name & Degree
Brig Ahsin Manzoor Bhatti, MBBS FCPS FRCS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA
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