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Combined Intra-articular Shoulder Injection and Stellate Ganglion Block in Chronic Post-mastectomy Shoulder Pain

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ClinicalTrials.gov Identifier: NCT03586154
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nevert Adel, Mansoura University

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Combination Product: Platelet rich plasma Drug: ketamine and bupivacaine injection Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Investigators were not allowed to know randomization codes and block size until all calculations and measurements had been entered into the database for all patients. All medical caregivers, investigators and patients were blinded to group allocation. One hour before the injection procedure of an enrolled patient, a nurse (not otherwise participating in the study) opened a sealed opaque envelope containing group allocation, and then filled the assigned drug injection for each patient according to the protocol of randomization.
Primary Purpose: Treatment
Official Title: Combined Platelet Rich Plasma Intra-articular Shoulder Injection and Stellate Ganglion Block. A New Technique for Management of Chronic Post-mastectomy Shoulder Pain Syndrome
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Group A
patients were subjected to ultrasound guided SGB using 1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml
Drug: ketamine and bupivacaine injection
1 ml ketamine in a dose of o.5 ml/kg plus 5ml bupivacaine 0.5% in a total volume 10 ml

Active Comparator: Group B
patients were subjected to ultrasound guided SGB using 1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml plus posterior approach shoulder injection with PRP.
Combination Product: Platelet rich plasma
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
Other Name: PRP

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




Primary Outcome Measures :
  1. Visual analogue score [ Time Frame: Before injection and 1, 2, 3 months after injection ]
    Visual analogue score (VAS) was done at rest and at shoulder movement before injection, one, two and three months after injection. VAS was explained to the patients during assessment as 0 equal no pain and 10 equal worst imaginable pain. Shoulder mobility was assessed while the patient was sitting using goniometry.


Secondary Outcome Measures :
  1. Range of motion [ Time Frame: Before injection and one month after injection ]
    It was measured in degrees in five position (extension, flexion, and abduction, internal and external rotation) before and one month after injection.

  2. Disability of arm [ Time Frame: Before injection and 1, 2 , 3 months after injection ]
    shoulder and hand (DASH) questionnaire was done before injection, one, two and three months after injection.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-mastectomy shoulder pain
  • age of 18 to less than 65 years

Exclusion Criteria:

  • refusal to participate
  • Patients with acute shoulder pain (trauma, acute postsurgical pain)
  • secondary adhesive capsulitis (prior surgery or non-surgically induced states of shoulder affection by adhesive capsulitis)
  • hypersensitivity to amide local anesthetics
  • general contraindications to SGB and cardiac and hepatic, renal or respiratory failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586154


Locations
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Egypt
MansouraU
Mansourah, Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohamed Tahan, MD Professor of Anesthesia, Medical Faculty, Mansoura University

Additional Information:
Publications:

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Responsible Party: Nevert Adel, Principal investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03586154     History of Changes
Other Study ID Numbers: MansouraU Nevert
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nevert Adel, Mansoura University:
Ketamine; pain; platelet rich plasma; mastectomy; shoulder

Additional relevant MeSH terms:
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Breast Neoplasms
Shoulder Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action