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

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01589354
• Other study ID #: 10/S0801/74
• Status: Not yet recruiting
• Phase: N/A
• First received: April 29, 2012
• Last updated: April 30, 2012
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: April 2012
• Source: NHS Grampian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: NHS Grampian
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

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.
• 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

Device:
• Ultrasound guided technique
The block will be performed under U/S guidance

Drug:
• Ropivacaine
20ml of 0.375% Ropivacaine
• Ropivacaine
20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NHS Grampian

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation		24 months	No
Secondary	Post-operative analgesic requirements in the first 24 hours after surgery		24 months	No
Secondary	Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures		24 months	No