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

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ClinicalTrials.gov Identifier: NCT01589354
Recruitment Status : Unknown
Verified April 2012 by Amr M Mahdy, NHS Grampian.
Recruitment status was:  Not yet recruiting
First Posted : May 1, 2012
Last Update Posted : May 2, 2012
Sponsor:
Information provided by (Responsible Party):

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
Postoperative Analgesia Procedure: Interscalene brachial plexus block Procedure: Intra-articular Ropivacaine injection Device: Ultrasound guided technique Drug: Ropivacaine

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

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U.S. FDA Resources

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 [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Post-operative analgesic requirements in the first 24 hours after surgery [ Time Frame: 24 months ]
  2. Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures [ Time Frame: 24 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589354


Sponsors and Collaborators
NHS Grampian
Investigators
Principal Investigator: Amr M Mahdy, MD NHS Grampian
More Information

Responsible Party: Amr M Mahdy, Dr, NHS Grampian
ClinicalTrials.gov Identifier: NCT01589354     History of Changes
Other Study ID Numbers: 10/S0801/74
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents