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

NCT03586154 | Completed Phase 4 DMC

• 1 other identifier: MansouraU Nevert
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Ketamine; pain; platelet rich plasma; mastectomy; shoulder

Outcome Measures

Primary Outcomes (1)

• Visual analogue score

  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.

  Before injection and 1, 2, 3 months after injection

Secondary Outcomes (2)

• Range of motion

  Before injection and one month after injection

• Disability of arm

  Before injection and 1, 2 , 3 months after injection

Study Arms (2)

Group A

OTHER

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

Group B

ACTIVE COMPARATOR

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; Drug: ketamine and bupivacaine injection

Interventions

Platelet rich plasma COMBINATION_PRODUCT

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

Also known as: PRP

Group B

ketamine and bupivacaine injection DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

MansouraU

Al Mansurah, Mansoura, 35516, Egypt

Location

Related Publications (11)

• Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.

  PMID: 15655557 BACKGROUND

• Waltho D, Rockwell G. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion. Can J Surg. 2016 Sep;59(5):342-50. doi: 10.1503/cjs.000716.

  PMID: 27668333 BACKGROUND

• Ebaugh D, Spinelli B, Schmitz KH. Shoulder impairments and their association with symptomatic rotator cuff disease in breast cancer survivors. Med Hypotheses. 2011 Oct;77(4):481-7. doi: 10.1016/j.mehy.2011.06.015. Epub 2011 Jul 18.

  PMID: 21764521 BACKGROUND

• Leonidou A, Woods DA. A preliminary study of manipulation under anaesthesia for secondary frozen shoulder following breast cancer treatment. Ann R Coll Surg Engl. 2014 Mar;96(2):111-5. doi: 10.1308/003588414X13824511649652.

  PMID: 24780667 BACKGROUND

• Yang S, Park DH, Ahn SH, Kim J, Lee JW, Han JY, Kim DK, Jeon JY, Choi KH, Kim W. Prevalence and risk factors of adhesive capsulitis of the shoulder after breast cancer treatment. Support Care Cancer. 2017 Apr;25(4):1317-1322. doi: 10.1007/s00520-016-3532-4. Epub 2016 Dec 9.

  PMID: 27942856 BACKGROUND

• Aslani H, Nourbakhsh ST, Zafarani Z, Ahmadi-Bani M, Ananloo ME, Beigy M, Salehi S. Platelet-Rich Plasma for Frozen Shoulder: A Case Report. Arch Bone Jt Surg. 2016 Jan;4(1):90-3.

  PMID: 26894228 BACKGROUND

• Lipov EG, Joshi JR, Sanders S, Slavin KV. A unifying theory linking the prolonged efficacy of the stellate ganglion block for the treatment of chronic regional pain syndrome (CRPS), hot flashes, and posttraumatic stress disorder (PTSD). Med Hypotheses. 2009 Jun;72(6):657-61. doi: 10.1016/j.mehy.2009.01.009. Epub 2009 Feb 23.

  PMID: 19237252 BACKGROUND

• Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.

  PMID: 26831629 BACKGROUND

• Peng PW, Cheng P. Ultrasound-guided interventional procedures in pain medicine: a review of anatomy, sonoanatomy, and procedures. Part III: shoulder. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):592-605. doi: 10.1097/AAP.0b013e318231e068.

  PMID: 22005657 BACKGROUND

• Stubblefield MD, Custodio CM. Upper-extremity pain disorders in breast cancer. Arch Phys Med Rehabil. 2006 Mar;87(3 Suppl 1):S96-9; quiz S100-1. doi: 10.1016/j.apmr.2005.12.017.

  PMID: 16500198 BACKGROUND

• Kulkarni KR, Kadam AI, Namazi IJ. Efficacy of stellate ganglion block with an adjuvant ketamine for peripheral vascular disease of the upper limbs. Indian J Anaesth. 2010 Nov;54(6):546-51. doi: 10.4103/0019-5049.72645.

  PMID: 21224973 BACKGROUND

Related Links

• Urbaniak GC, Plous S. Research randomizer. Retrieved July. 1997;7:2008.
• Sweeny J, Grossman BJ. Blood collection, storage and component preparation methods. Tech Manual 14th ed Bethesda MD Am Assoc Blood Banks. 2002;955-8.
• Welsh WJ. Autologous platelet gel: clinical function and usage in plastic surgery. Cosmet Derm. 2000;11:13.

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Ketamine; Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Mohamed Tahan, MD

  Professor of Anesthesia, Medical Faculty, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 13, 2018
• Study Start: August 1, 2017
• Primary Completion: January 2, 2018
• Study Completion: April 2, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)