CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Platelet rich plasma +1 morecombination
Likely dose
Platelet rich plasma 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03586154
NCT03586154Phase 4Completed

Combined Platelet Rich Plasma Intra-articular Shoulder Injection and Stellate Ganglion Block. A New Technique for Management of Chronic Post-mastectomy Shoulder Pain Syndrome

Mansoura University·interventional·Posted Jul 13, 2018·Updated Jul 16, 2018

In Brief

A Phase 4 clinical trial evaluating Platelet rich plasma and ketamine and bupivacaine injection for Breast Neoplasms. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Background and Purpose: Adhesive capsulitis of the shoulder is commonly found in patients after breast cancer treatment. We aimed to determine the effectiveness of combined shoulder joint intra-articular injection of platelet rich plasma (PRP) with stellate ganglion block (SGB) with ketamine \&bupivacaine injection as a new technique for frozen shoulder (FS) management after mastectomy. Methods: Sixty four patients with chronic post-mastectomy shoulder pain and stiffness were randomly allocated into one of two groups: group A; ultrasound guided SGB (1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml) and group B; ultrasound guided SGB plus posterior approach shoulder injection with PRP. Visual analogue score (VAS) at rest and at shoulder movement, range of motions (ROM) of shoulder and disability of arm, shoulder and hand (DASH) questionnaire were recorded.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJul 13, 2018
Enrollment StartAug 1, 2017
Primary CompletionJan 2, 2018
Study CompletionApr 2, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.0 years ago

Interventions

Platelet rich plasmacombination

combined platelet rich plasma and 1 ml ketamine in a dose of o.5 ml/kg plus 5ml bupivacaine 0.5% in a total volume 10 ml

ketamine and bupivacaine injectiondrug

1 ml ketamine in a dose of o.5 ml/kg plus 5ml bupivacaine 0.5% in a total volume 10 ml