Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

Pain Clinical Trial

Official title:

Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576223
• Other study ID #: H-15008712
• Secondary ID: 2015-002391-24
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: August 27, 2018

Study information

• Verified date: March 2024
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ropivacaine hydrochloride
Ropivacaine injected perineural at the suprascapular nerve.
• Isotonic Saline
Saline injected perineural at the suprascapular nerve.
• PCA-pump
PCA (Patient controlled analgesia) pump with the following settings: Age > 70 years or weight < 60 kg: bolus dose 2,5 mg i.v. morphine, 15 minutes lockout Age < 70 years and weight > 60 kg: bolus dose 5 mg i.v. morphine, 15 minutes lockout Lockout time 15 minutes.

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Holbæk Sygehus	Holbæk

Sponsors (1)

Lead Sponsor	Collaborator
Kai Henrik Wiborg Lange

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS) score at rest at T½	Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).	Baseline to 30 minutes
Secondary	VAS score during maximum active shoulder abduction from T½ to T6	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).	½, 1, 2, 3, 4, 5, 6 hours
Secondary	VAS score at rest from T½ to T6	VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) at rest and calculated as area under the curve (AUC).	½, 1, 2, 3, 4, 5, 6 hours
Secondary	Morphine consumption.	The total amount of morphine administered via the intravenous PCA pump the first 6 hours after nerve block.	6 hours
Secondary	Electromyography at T½	Change in activity of the infraspinatus muscle measured with surface electromyography from baseline to T½.	Baseline to 30 minutes
Secondary	Muscle strength at T½	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.	Baseline to 30 minutes