EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVE... | NCT04610307

Studies
EFFECT OF BUFFERED LOCAL ANESTHESIA ON PAIN IN ARETERIOVENOUS FISTULA

NCT04610307

Sponsor

Combined Military Hospital, Pakistan

Status

Unknown status

Last Update Posted

Nov 3, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Pain, Procedural
Pain, Postoperative
Satisfaction, Patient

Interventions

buffered anesthesia

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Estimated

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Oct 26, 2020

First Submission Date that Met QC Criteria

Oct 26, 2020

First Posted Date

Oct 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2020

Last Update Posted Date

Nov 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Anum Arif, Dr Anum Arif, Combined Military Hospital, PakistanPrincipal Investigator

Lead Sponsor

Combined Military Hospital, PakistanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Placebo Comparator	patients receiving 1 % plain xylocaine	Procedure: buffered anesthesia
intervention group	Experimental	patients receiving buffered 1 % xylocaine	Procedure: buffered anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
buffered anesthesia	Procedure	patients will undergo surgery under buffered local anesthesia	control group intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	60 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anum Arif	Contact	+923422398424		dranumarif@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Combined Military Hospital		Lahore		0092	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073818	Pain, Procedural
D010149	Pain, Postoperative
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided