Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Amr M Mahdy, NHS Grampian.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Amr M Mahdy, NHS Grampian Identifier:
First received: April 29, 2012
Last updated: April 30, 2012
Last verified: April 2012
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 Intervention
Postoperative Analgesia
Procedure: Interscalene brachial plexus block
Procedure: Intra-articular Ropivacaine injection
Device: Ultrasound guided technique
Drug: Ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Amr M Mahdy, NHS Grampian:

Primary Outcome Measures:
  • Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation [ Time Frame: 24 months ]

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

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01589354

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

Responsible Party: Amr M Mahdy, Dr, NHS Grampian Identifier: NCT01589354     History of Changes
Other Study ID Numbers: 10/S0801/74
Study First Received: April 29, 2012
Last Updated: April 30, 2012

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017