Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ropivacaine hydrochloride; Drug: Isotonic Saline; Drug: PCA-pump

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordsjællands Hospital
  • Holbæk, Denmark, 4300
    • Holbæk Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine hydrochloride; Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.	Drug: Ropivacaine hydrochloride; Ropivacaine injected perineural at the suprascapular nerve.; Other Names: Ropivacaine, Naropin; Drug: 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.; Other Names: Morphine
Placebo Comparator: Isotonic Saline; 0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.	Drug: Isotonic Saline; Saline injected perineural at the suprascapular nerve.; Other Names: Saline; Drug: 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.; Other Names: Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption.	The total amount of morphine administered via the intravenous PCA pump the first 6 hours after nerve block.	6 hours
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
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
Electromyography at T½	Change in activity of the infraspinatus muscle measured with surface electromyography from baseline to T½.	Baseline to 30 minutes
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

Collaborators and Investigators

• Sponsor: Kai Henrik Wiborg Lange
• Investigators: Principal Investigator: Christian Steen-Hansen, Nordsjællands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimated): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral Nerve Blocks
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: H-15008712; 2015-002391-24 (EudraCT Number)