Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

Kai Henrik Wiborg Lange

Status: Completed

Conditions: Pain

Treatments: Drug: PCA-pump; Drug: Ropivacaine hydrochloride; Drug: Isotonic Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02576223

H-15008712

2015-002391-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients planned for arthroscopic shoulder surgery.
• Age ≥ 18.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Ropivacaine hydrochloride

Active Comparator group

Description:

Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.

Treatment:

Drug: Ropivacaine hydrochloride

Drug: PCA-pump

Isotonic Saline

Placebo Comparator group

Description:

0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.

Treatment:

Drug: Isotonic Saline

Drug: PCA-pump