NCT04620720

Brief Summary

we will assess post operative pain after surgery of modified radical mastectomy at 12 and 24 hours post operatively on arm movement and on rest

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
51

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2020

Shorter than P25 for early_phase_1

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

Study Start

First participant enrolled

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
22 days 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 9, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 4, 2020

Last Update Submit

November 4, 2020

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • post operative pain score

    Visual analog score for pain from 0 to 10. O means no pain. 1 is least and 10 is most severe pain

    12 hours post oepratively

Secondary Outcomes (1)

  • analgesia requirement

    12 hours post oepratively

Study Arms (2)

control group

NO INTERVENTION

routuine analgesics wil be given

intervention group

EXPERIMENTAL

patient will receive cap gabapentin 1200 mg 2 hours before surgery

Drug: capule gabapentin

Interventions

capule gabapentinDRUG

neuropathic analgesic

intervention group

Eligibility Criteria

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

You may qualify if:

  • All Females, age ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study

You may not qualify if:

  • Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in previous 8 weeks , Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants ,analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension and Acute or Chronic Renal Failure on the basis of medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anum

Karachi, Select A State Or Province, 00921, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Anum Arif, MBBS FCPS

    Combined military hospital lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anum Arif, MBBS FCPS

CONTACT

+923422398424dranumarif@yahoo.com

Ammad Asim, MBBS FCPS

CONTACT

+923422398424ammadasim@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Anum Arif

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 9, 2020

Study Start

August 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)