Clinical trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on recovery after hip and knee replacements

Start 3 Feb 2023 · End 6 Apr 2025 · Status Ended · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ended

Participants planned 222

Countries 1

Sites 2

Osteoarthritis of the hip and knee

Investigating whether or not participants are able to safely and independently walk 5 meters (also when using walking aid) within 6 hours of surgery depending on the type of anaesthesia used.

Key facts

Sponsor: Hvidovre Hospital
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Musculoskeletal Diseases [C05], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
Trial duration: 3 Feb 2023 → 6 Apr 2025
Decision date (initial): 2022-11-17
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No
Funding sources: The Novo Nordisk Foundation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Investigating whether or not participants are able to safely and independently walk 5 meters (also when using walking aid) within 6 hours of surgery depending on the type of anaesthesia used.

Secondary objectives 2

Evaluate postoperative pain, fulfilment of discharge criteria, vital signs, nausea and vomiting, dizziness, quality of recovery, postoperative delirium, urinary retention and use of pain medication depending on the type of anaesthesia used
Evaluate occurence of emergency room contacts, complications, readmissions and mortality within 30 days of surgery.

Conditions and MedDRA coding

Osteoarthritis of the hip and knee

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Clinical and radiological knee osteoarthritis meeting the indications for primary total hip, total knee or unicompartmental knee arthroplasty. ≥18 years of age. Able to speak and understand Danish. Able to give informed consent and must be cognitively intact.

Exclusion criteria 1

Lives in an institution. Uses walking aid such as a walker or a wheelchair. Terminal illness. Has contraindications for either general or spinal anaesthesia. Has objections to receiving either general or spinal anaesthesia. Requires anxiolytics as premedication prior to anaesthesia. Traumatic aetiology as a basis for surgical indication. Altered pain perception and / or neurologic affection due to diabetes or other disorders. Daily preoperative use of opioids > 30 mg of morphine milligram equivalents (MME). Standard primary arthroplasty procedure is evaluated not to be suitable.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Whether or not the participant is able to safely and independently walk 5 meters (also when using walking aid) within 6 hours of surgery.

Secondary endpoints 9

Fulfilment of discharge criteria
Pain score and opioid use
Postoperative nausea and vomiting (PONV)
Dizziness score
Quality of Recovery (QoR-15)
Opioid-Related Symptom Distress Scale (ORSDS) questionnaire
3-minute Diagnostic Interview – Confusion Assessment Method (3D-CAM)
Urinary retention
Emergency room contacts, complications, readmission or mortality within 30 days of surgery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Bupivacaine Hydrochloride

SUB00902MIG · Substance

Active substance: Bupivacaine Hydrochloride
Pharmaceutical form: INJECTION
Route of administration: INTRATHECAL
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remifentanil

SUB10272MIG · Substance

Active substance: Remifentanil
Pharmaceutical form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 20000 µg microgram(s)
Max total dose: 20000 µg microgram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remifentanil

SUB10272MIG · Substance

Active substance: Remifentanil
Pharmaceutical form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 20000 µg microgram(s)
Max total dose: 20000 µg microgram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Remifentanil

SUB10272MIG · Substance

Active substance: Remifentanil
Pharmaceutical form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 20000 µg microgram(s)
Max total dose: 20000 µg microgram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Propofol

SUB10116MIG · Substance

Active substance: Propofol
Pharmaceutical form: EMULSION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 3400 mg milligram(s)
Max total dose: 3400
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Propofol

SUB10116MIG · Substance

Active substance: Propofol
Pharmaceutical form: EMULSION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 3400 mg milligram(s)
Max total dose: 3400 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 11

Ropivacaine Hydrochloride

SUB04264MIG · Substance

Active substance: Ropivacaine Hydrochloride
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: LOCAL INJECTION
Max daily dose: 200 ml millilitre(s)
Max total dose: 200 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ondansetron

SUB09445MIG · Substance

Active substance: Ondansetron
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 8 mg milligram(s)
Max total dose: 8 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tranexamic Acid

SUB11214MIG · Substance

Active substance: Tranexamic Acid
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 4 g gram(s)
Max total dose: 4 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sodium Lactate

SUB15300MIG · Substance

Active substance: Sodium Lactate
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INFUSION
Max daily dose: 10 l litre(s)
Max total dose: 10 l litre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sufentanil

SUB10671MIG · Substance

Active substance: Sufentanil
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 5 µg/Kg microgram(s)/kilogram
Max total dose: 5 µg/Kg microgram(s)/kilogram
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Celecoxib

SUB01143MIG · Substance

Active substance: Celecoxib
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 800 mg milligram(s)
Max total dose: 6400 mg milligram(s)
Max treatment duration: 8 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Calcium Chloride

SUB11767MIG · Substance

Active substance: Calcium Chloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INFUSION
Max daily dose: 10 l litre(s)
Max total dose: 10 l litre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone Phosphate

SUB01612MIG · Substance

Active substance: Dexamethasone Phosphate
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Paracetamol

SUB09611MIG · Substance

Active substance: Paracetamol
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 4 g gram(s)
Max total dose: 32 g gram(s)
Max treatment duration: 8 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sodium Chloride

SUB12581MIG · Substance

Active substance: Sodium Chloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INFUSION
Max daily dose: 10 l litre(s)
Max total dose: 10 l litre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Potassium Chloride

SUB12559MIG · Substance

Active substance: Potassium Chloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INFUSION
Max daily dose: 5 l litre(s)
Max total dose: 5 l litre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hvidovre Hospital

Sponsor organisation: Hvidovre Hospital
Address: Kettegaard Alle 30
City: Hvidovre
Postcode: 2650
Country: Denmark

Scientific contact point

Organisation: Hvidovre Hospital
Contact name: Christian Bredgaard Jensen

Public contact point

Organisation: Hvidovre Hospital
Contact name: Christian Bredgaard Jensen

Third parties 1

Organisation	City, country	Duties
Frederiksberg Hospital ORG-100028217	Frederiksberg, Denmark	On site monitoring

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ended	222	2
Rest of world	—	0	—

Investigational sites

Denmark

2 sites · Ended

Vejle Hospital

Orthopaedic Surgery, Kabbeltoft 25, 7100, Vejle

Hvidovre Hospital

Orthopaedic Surgery, Kettegaard Alle 30, 2650, Hvidovre

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Denmark	2023-02-03	2025-04-06	2023-03-06	2025-03-05

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Title	Submission date	Status	Type
Summary af results SUM-127571	2026-04-04T21:06:23	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
Lay person summary	2026-04-04T21:07:08	Submitted	Laypersons Summary of Results

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Laypersons summary of results (for publication)	Summary of results incl lay description SAGA	1
Protocol (for publication)	Protocol RCT SAGA	1.3
Summary of Product Characteristics (SmPC) (for publication)	Marcain Spinal injektionsvske oplsning 5 mgml	1
Summary of Product Characteristics (SmPC) (for publication)	Marcain Spinal Tung injektionsvske oplsning 5 mgml	1
Summary of Product Characteristics (SmPC) (for publication)	Propolipid injektions og infusionsvske emulsion 10 mgml	1
Summary of Product Characteristics (SmPC) (for publication)	Propolipid injektions og infusionsvske emulsion 20 mgml	1
Summary of Product Characteristics (SmPC) (for publication)	Remifentanil Fresenius Kabi pulver 1 mg 2 mg 5 mg	1
Summary of results (for publication)	Summary of results incl lay description SAGA	1
Synopsis of the protocol (for publication)	Protokol resume dansk RCT SAGA	1.2

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2022-08-19	Denmark	Acceptable 2022-11-01	2022-11-17
2	SUBSTANTIAL MODIFICATION	SM-1	2022-12-12	Denmark	Acceptable 2023-01-19	2023-01-20
3	SUBSTANTIAL MODIFICATION	SM-2	2023-06-05	Denmark	Acceptable 2023-07-11	2023-07-11
4	SUBSTANTIAL MODIFICATION	SM-4	2024-11-25	Denmark	Acceptable 2024-12-02	2024-12-03

Clinical trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on recovery after hip and knee replacements

Overview

Key facts

Trial design

Main objective

Secondary objectives 2

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 1

Exclusion criteria 1

Endpoints

Primary endpoints 1

Secondary endpoints 9

Investigational products

Test 6

Auxiliary 11

Sponsors and contacts

Hvidovre Hospital

Scientific contact point

Public contact point

Third parties 1

Locations

By country

Investigational sites

Country notifications

Results and documents

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 9 files

Application history

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