Clinical trial NCT02576223: Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery
Official title: Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Peripheral Nerve Blocks
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale (VAS) score at rest at T½
timeFrame: Baseline to 30 minutes
Secondary outcomes:
measure: VAS score during maximum active shoulder abduction from T½ to T6
timeFrame: ½, 1, 2, 3, 4, 5, 6 hours
measure: VAS score at rest from T½ to T6
timeFrame: ½, 1, 2, 3, 4, 5, 6 hours
measure: Morphine consumption.
timeFrame: 6 hours
measure: Electromyography at T½
timeFrame: Baseline to 30 minutes
measure: Muscle strength at T½
timeFrame: Baseline to 30 minutes
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
Study officials:
affiliation: Nordsjællands Hospital
name: Christian Steen-Hansen
role: PRINCIPAL_INVESTIGATOR
References: