NCT04610307

Brief Summary

Pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 26, 2020

Last Update Submit

October 30, 2020

Conditions

Pain, ProceduralPain, PostoperativeSatisfaction, Patient

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

control group

PLACEBO COMPARATOR

patients receiving 1 % plain xylocaine

Procedure: buffered anesthesia

intervention group

EXPERIMENTAL

patients receiving buffered 1 % xylocaine

Procedure: buffered anesthesia

Interventions

buffered anesthesiaPROCEDURE

patients will undergo surgery under buffered local anesthesia

control groupintervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I to III
  • Brachiocephalic arteriovenous fistula
  • Radiocephalic arteriovenous fistula

You may not qualify if:

  • basiic vein transposition
  • redo surgery emergency surgery
  • failure to understand the questionnnare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital

Lahore, 0092, Pakistan

Location

MeSH Terms

Conditions

Pain, ProceduralPain, PostoperativePatient Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Anum Arif

CONTACT

+923422398424dranumarif@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Anum Arif

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 30, 2020

Study Start

November 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)