Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Ropivacaine hydrochloride
- Conditions
- Pain
- Sponsor
- Kai Henrik Wiborg Lange
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Visual analogue scale (VAS) score at rest at T½
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline.
Detailed Description
Postoperative pain management after arthroscopic shoulder surgery traditionally includes opioids and/or an interscalene brachial plexus block(IBPB). Opioid consumption often leads to unpleasant side effects including nausea, vomitting and sedation. IBPB offers very efficient pain relief but includes the discomfort of a paralyzed arm. Furthermore this approach often also leads to unilateral paresis of the phrenic nerve causing reduced respiratory capacity. The latter offering discomfort and a potential risk in patients with lung diseases or heavy overweight. The suprascapular nerve is the most important nerve to the shoulder and a selective block of this nerve could offer a good pain relief without the mentioned side effects. In this randomized study the investigators wish to examine the pain relieving effect of a selective block of the suprascapular nerve after arthroscopic shoulder surgery. 40 patients are randomized to a block of this nerve with either active drug (Ropivacaine) or placebo (Saline). All patients will get a PCA (Patient Controlled Analgesia) pump for administration of i.v. morphine in doses based on age and weight. Patient are being monitored for 6 hours. The primary outcome is reduction in VAS at rest from baseline to 30 minutes after nerve block.
Investigators
Kai Henrik Wiborg Lange
Head of Research
Hillerod Hospital, Denmark
Eligibility Criteria
Inclusion Criteria
- •Patients planned for arthroscopic shoulder surgery.
- •ASA class ≤ 3.
Exclusion Criteria
- •Patients with VAS never ≥5 mm during the first hour after arrivel to the post anesthesia care unit.
- •Patients unable to cooperate.
- •Patients unable to understand or speak danish.
- •Allergy towards the used drugs.
- •Abuse of alcohol- and/or medicine - investigators assessment.
- •Usage of opioids on a daily basis (not including Tramadole).
- •Pregnancy (It is obligatory for all fertile women in the study to take a hcg urine test).
- •Operations involving the clavicle.
- •Operations converted to open surgery.
Arms & Interventions
Ropivacaine hydrochloride
Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.
Intervention: Ropivacaine hydrochloride
Ropivacaine hydrochloride
Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.
Intervention: PCA-pump
Isotonic Saline
0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.
Intervention: Isotonic Saline
Isotonic Saline
0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.
Intervention: PCA-pump
Outcomes
Primary Outcomes
Visual analogue scale (VAS) score at rest at T½
Time Frame: Baseline to 30 minutes
Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).
Secondary Outcomes
- VAS score during maximum active shoulder abduction from T½ to T6(½, 1, 2, 3, 4, 5, 6 hours)
- Morphine consumption.(6 hours)
- VAS score at rest from T½ to T6(½, 1, 2, 3, 4, 5, 6 hours)
- Muscle strength at T½(Baseline to 30 minutes)
- Electromyography at T½(Baseline to 30 minutes)