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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03253198
Other study ID # 2017SNam
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date July 2017

Study information

Verified date May 2018
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date July 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

- Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia

- Revision arthroplasty or arthroplasty for fracture

- Unable/unwilling to consent for enrollment

- Unable to complete postoperative pain survey

- Known adverse drug reaction or allergy to the medications used

- Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)

- Patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone)

- Patients under the age of 18 years

- Patients with history of hepatic disease

- Pregnant or breastfeeding women.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Saline
A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative
Bupivacaine liposome
an interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)

Locations

Country Name City State
United States Rothman Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary morphine and morphine equivalent consumption 24 hours post surgery
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06464770 - Optimizing Infection Prophylaxis Prior to Shoulder Surgery N/A