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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Procedure: Interscalene brachial plexus block; Device: Ultrasound guided technique; Drug: Ropivacaine; Drug: Ropivacaine; Procedure: Intra-articular Ropivacaine injection

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-articular injection	Drug: Ropivacaine; 20ml of 0.375% Ropivacaine; Drug: Ropivacaine; 20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure; 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
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; Drug: Ropivacaine; 20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: April 29, 2012
• First Submitted That Met QC Criteria: April 29, 2012
• First Posted (Estimate): May 1, 2012

Study Record Updates

• Last Update Posted (Estimate): May 2, 2012
• Last Update Submitted That Met QC Criteria: April 30, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 10/S0801/74