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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01589354
Other study ID # 10/S0801/74
Secondary ID
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


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
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