Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery

• Sponsor: NHS Grampian (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01589354
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Analgesia	Procedure: Interscalene brachial plexus block; Procedure: Intra-articular Ropivacaine injection; Device: Ultrasound guided technique; Drug: Ropivacaine; Drug: Ropivacaine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
• Study Start Date: May 1, 2012
• Anticipated Primary Completion Date: May 1, 2014
• Anticipated Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interscalene brachial plexus block	Procedure: Interscalene brachial plexus block; 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.; Device: Ultrasound guided technique; The block will be performed under U/S guidance; Drug: Ropivacaine; 20ml of 0.375% Ropivacaine
Experimental: Intra-articular injection	Procedure: Intra-articular Ropivacaine injection; 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; Drug: Ropivacaine; 20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure

Outcome Measures

Primary Outcome Measures

1. Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation [24 months]

Secondary Outcome Measures

1. Post-operative analgesic requirements in the first 24 hours after surgery [24 months]

2. Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NHS Grampian

Investigators

• Principal Investigator: Amr M Mahdy, MD, NHS Grampian

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr M Mahdy, Dr, NHS Grampian
• ClinicalTrials.gov Identifier: NCT01589354
• Other Study ID Numbers: 10/S0801/74
• First Posted: May 1, 2012
• Last Update Posted: May 2, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Agnosia; Ropivacaine

Study Results

No Results Posted as of May 2, 2012