Suprascapular Nerve Block as Postoperative Analgesia Afte... | NCT02576223

Studies
Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

NCT02576223

Sponsor

Kai Henrik Wiborg Lange

Status

Completed

Last Update Posted

Mar 21, 2024Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Ropivacaine hydrochloride
Isotonic Saline
PCA-pump

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-002391-24	EudraCT Number

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015Actual

Primary Completion Date

Aug 27, 2018Actual

Completion Date

Aug 27, 2018Actual

First Submitted Date

Oct 13, 2015

First Submission Date that Met QC Criteria

Oct 14, 2015

First Posted Date

Oct 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2024

Last Update Posted Date

Mar 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kai Henrik Wiborg Lange, Head of Research, Hillerod Hospital, DenmarkSponsor-Investigator

Lead Sponsor

Kai Henrik Wiborg LangeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ropivacaine hydrochloride	Active Comparator	Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.	Drug: Ropivacaine hydrochloride Drug: PCA-pump
Isotonic Saline	Placebo Comparator	0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.	Drug: Isotonic Saline Drug: PCA-pump

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine hydrochloride	Drug	Ropivacaine injected perineural at the suprascapular nerve.	Ropivacaine hydrochloride

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Steen-Hansen	Nordsjaellands Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nordsjællands Hospital		Hillerød		3400	Denmark
Holbæk Sygehus

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine
D012965	Sodium Chloride
D009020	Morphine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided