Back to resultsEffectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
Primary Purpose
Postoperative Analgesia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interscalene brachial plexus block
Intra-articular Ropivacaine injection
Ultrasound guided technique
Ropivacaine
Ropivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Analgesia
Eligibility Criteria
Inclusion Criteria:
• All adult patients above the age of 18 years undergoing arthroscopic shoulder stabilisation operation
Exclusion Criteria:
- Patients not meeting inclusion criteria
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interscalene brachial plexus block
Intra-articular injection
Arm Description
Outcomes
Primary Outcome Measures
Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation
Secondary Outcome Measures
Post-operative analgesic requirements in the first 24 hours after surgery
Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01589354
Brief Title
Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
Official Title
Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Grampian
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interscalene brachial plexus block
Arm Type
Experimental
Arm Title
Intra-articular injection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Interscalene brachial plexus block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intra-articular Ropivacaine injection
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Ultrasound guided technique
Intervention Description
The block will be performed under U/S guidance
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
20ml of 0.375% Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure
Primary Outcome Measure Information:
Title
Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Post-operative analgesic requirements in the first 24 hours after surgery
Time Frame
24 months
Title
Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• All adult patients above the age of 18 years undergoing arthroscopic shoulder stabilisation operation
Exclusion Criteria:
Patients not meeting inclusion criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M Mahdy, MD
Organizational Affiliation
NHS Grampian
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
We'll reach out to this number within 24 hrs