NCT02970058

Brief Summary

Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration 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

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

November 17, 2016

Last Update Submit

March 13, 2020

Conditions

Platelet-rich Plasma in Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    7 days

Study Arms (2)

Platelet-rich Plasma

ACTIVE COMPARATOR

30 patients will receive platelet-rich plasma post-spinal anesthesia

Other: Platelet-rich Plasma

Control

PLACEBO COMPARATOR

30 patients will receive sterile saline post-spinal anesthesia

Other: Control

Interventions

Platelet-rich PlasmaOTHER

The active group will receive Platelet-rich Plasma following spinal injection

Platelet-rich Plasma
ControlOTHER

The control group will receive saline as a placebo

Control

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective gynecological surgery.

You may not qualify if:

  • Spinal Pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

RECRUITING

Central Study Contacts

mohmed Bakri, prof

CONTACT

+20882413201mhbakri@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

March 7, 2018

Primary Completion

July 1, 2020

Study Completion

July 15, 2020

Last Updated

March 16, 2020

Record last verified: 2019-03

Locations

EG(1)