Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

NCT ID: NCT02576223

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-08-27

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine hydrochloride

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine hydrochloride

Intervention Type: DRUG

Ropivacaine injected perineural at the suprascapular nerve.

PCA-pump

Intervention Type: DRUG

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.

Isotonic Saline

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

Group Type: PLACEBO_COMPARATOR

Isotonic Saline

Intervention Type: DRUG

Saline injected perineural at the suprascapular nerve.

PCA-pump

Intervention Type: DRUG

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.

Interventions

Ropivacaine hydrochloride

Ropivacaine injected perineural at the suprascapular nerve.

Intervention Type: DRUG

Isotonic Saline

Saline injected perineural at the suprascapular nerve.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ropivacaine, Naropin; Saline; Morphine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kai Henrik Wiborg Lange

OTHER

Sponsor Role: lead

Responsible Party

Kai Henrik Wiborg Lange

Head of Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian Steen-Hansen

Role: PRINCIPAL_INVESTIGATOR

Nordsjaellands Hospital

Locations

Nordsjællands Hospital

Hillerød, , Denmark

Holbæk Sygehus

Holbæk, , Denmark

Countries

Denmark

Other Identifiers

2015-002391-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-15008712

Identifier Type: -

Identifier Source: org_study_id