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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

This study is not yet open for participant recruitment.
Verified April 2012 by NHS Grampian
Sponsor:
Information provided by (Responsible Party):
Amr M Mahdy, NHS Grampian
ClinicalTrials.gov Identifier:
NCT01589354
First received: April 29, 2012
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by NHS Grampian:

Primary Outcome Measures:
  • Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative analgesic requirements in the first 24 hours after surgery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589354

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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 19, 2013