Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Ropivacaine hydrochloride; Drug: Isotonic Saline; Drug: PCA-pump

• Registration Number: NCT02576223
• Lead Sponsor: Kai Henrik Wiborg Lange

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-15
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine hydrochloride	Ropivacaine hydrochloride	Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.
Ropivacaine hydrochloride	PCA-pump	Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.
Isotonic Saline	Isotonic Saline	0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.
Isotonic Saline	PCA-pump	0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) score at rest at T½	Baseline to 30 minutes	Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).

Secondary Outcome Measures

Name	Time	Method
VAS score during maximum active shoulder abduction from T½ to T6	½, 1, 2, 3, 4, 5, 6 hours	VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) during maximal active shoulder abduction and calculated as area under the curve (AUC).
Morphine consumption.	6 hours	The total amount of morphine administered via the intravenous PCA pump the first 6 hours after nerve block.
VAS score at rest from T½ to T6	½, 1, 2, 3, 4, 5, 6 hours	VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) at rest and calculated as area under the curve (AUC).
Muscle strength at T½	Baseline to 30 minutes	Change in strength of the supraspinatus (abduction of the shoulder) and the infraspinatus muscle (external rotation of the shoulder) measured with a handheld dynamometer from baseline to T½.
Electromyography at T½	Baseline to 30 minutes	Change in activity of the infraspinatus muscle measured with surface electromyography from baseline to T½.

Trial Locations

Locations (2)

Holbæk Sygehus; 🇩🇰 Holbæk, Denmark

Nordsjællands Hospital; 🇩🇰 Hillerød, Denmark