Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
This study evaluates two anaesthetic techniques namely interscalene brachial plexus block and intra-articular local anaesthetic injection. Both techniques are currently used for providing postoperative pain relief following arthroscopic shoulder stabilisation operation. It will be a randomised controlled trial involving 30 patients in two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 2, 2012
April 1, 2012
2 years
April 29, 2012
April 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation
24 months
Secondary Outcomes (2)
Post-operative analgesic requirements in the first 24 hours after surgery
24 months
Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures
24 months
Study Arms (2)
Interscalene brachial plexus block
EXPERIMENTALIntra-articular injection
EXPERIMENTALInterventions
An interscalene block will be performed pre-operatively using ultrasound guidance and the peripheral nerve stimulator (with the patient awake) using 20 ml of 0.375% Ropivacaine.
The procedure will be done by the surgeon at the end of the operation, with an intra-articular injection of 20 ml 0.75% Ropivacaine through the arthroscopic cannula after closure of the anterior wound
The block will be performed under U/S guidance
Eligibility Criteria
You may qualify if:
- All adult patients above the age of 18 years undergoing arthroscopic shoulder stabilisation operation
You may not qualify if:
- Patients unable to give informed consent
- Patient refusal to participate in the study
- Contraindications to Interscalene block
- Allergy to local anaesthetics
- Peripheral neuropathy from any cause
- Patients on opiates for chronic pain
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Grampianlead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amr M Mahdy, MD
NHS Grampian
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 29, 2012
First Posted
May 1, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 2, 2012
Record last verified: 2012-04