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Osteo Arthritis Knee and HipPhase 4GASPSNCT07334132

General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty

A Phase 4 study testing General Anaesthesia and Spinal Anesthesia (bupivacaine) in people with Osteo Arthritis Knee and Hip and Osteo Arthritis, run by Region Örebro County.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis. An increasing number of these procedures are now performed as outpatient surgery, meaning that patients can go home on the same day as the operation. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
General Anaesthesia and Spinal Anesthesia (bupivacaine)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
No sites listed yet
Study dates
1 Apr 2026to 31 Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has given their written consent to participate in the trial.
  • Planned for primary TKA or THA.
  • Adults aged 18 to 80 years at time of written consent.
  • ASA (American Society of Anaesthesiologists) classification 1 or 2, or 3 without significant functional impairment.
  • Scheduled start of surgery before 13:00.
  • Ability to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures.

Who cannot join

  • Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
  • Body mass index (BMI) > 35 kg/m.
  • Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.
  • Haemoglobin < 120 g/L (sample no older than 3 months).
  • Known bleeding disorders, including coagulopathies.
  • Known allergies to investigational anaesthetic drugs (e.g., bupivacaine, remifentanil, or propofol).
Show all 12Show fewer
  • Neurological conditions with persistent motor or sensory deficits.
  • Localised infections at the spinal injection site.
  • Determined by the surgical or anaesthesia team to be unsuitable for trial participation and/or outpatient surgery.
  • Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile)
  • Who are not willing to use a highly effective method of contraception judged by the investigator, from the time of signing the informed consent, OR
  • Who has a positive pregnancy test at enrolment

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Erik Noppa, MD contact

+46 19-602 03 15

erik.noppa@oru.se

About this study

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis. An increasing number of these procedures are now performed as outpatient surgery, meaning that patients can go home on the same day as the operation. This can be beneficial for both patients and healthcare systems, but it requires safe and efficient anaesthetic care.

Two different types of anaesthesia are commonly used for these operations: general anaesthesia (where the patient is asleep) and spinal anaesthesia (where the lower part of the body is numbed). Both methods are well established and widely used. Previous studies suggest that the choice of anaesthesia may affect how quickly patients recover, how comfortable they feel after surgery, and whether they can be safely discharged on the day of surgery. However, most existing studies are based on retrospective data, and there is limited randomized evidence comparing these anaesthetic techniques in the outpatient setting.

Read more

The GASPS trial is a multicentre, randomized, phase IV clinical study that compares general anaesthesia and spinal anaesthesia in adults undergoing outpatient primary total knee or hip arthroplasty. A total of 600 participants will be included and randomly assigned to receive one of the two anaesthetic methods on the day of surgery. All participants will receive standard surgical and perioperative care, and both anaesthetic techniques are part of routine clinical practice.

The main aim of the study is to investigate whether the type of anaesthesia influences the chance of successful same-day discharge, defined as going home on the day of surgery without needing to be readmitted within 48 hours. The study will also examine recovery time, pain, nausea and vomiting, use of pain medication, complications, patient-reported recovery and function, and healthcare costs. In addition, patient experiences of anaesthesia and postoperative recovery will be explored through interviews in a smaller group of participants.

Participants will be followed using questionnaires and medical records from the day of surgery up to 12 months after the operation. The results of this study are expected to provide clear and reliable information to help guide anaesthetic care for patients undergoing outpatient hip and knee replacement surgery.

Read the detailed description

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are among the most frequently performed elective surgical procedures and are highly effective treatments for advanced joint disease, most commonly osteoarthritis. Over the past decade, improvements in surgical techniques, perioperative care pathways, anaesthetic management, and postoperative rehabilitation have enabled an increasing proportion of these procedures to be performed as outpatient surgery, allowing patients to return home on the day of surgery. Outpatient arthroplasty has the potential to improve patient satisfaction, reduce hospital length of stay, lower healthcare costs, and decrease the risk of hospital-acquired complications. However, achieving safe and successful same-day discharge requires carefully optimized perioperative care.

Anaesthetic management is a central component of outpatient arthroplasty pathways. Both general anaesthesia (GA) and spinal anaesthesia (SA) are routinely used for TKA and THA, and both techniques are well established with extensive safety data. Neuraxial anaesthesia has traditionally been associated with reduced intraoperative blood loss and certain postoperative complications, and it is commonly recommended in clinical guidelines for hip and knee arthroplasty. In contrast, modern general anaesthesia using short-acting intravenous agents may offer advantages in the outpatient setting, including predictable onset and offset, rapid recovery of motor function, and reduced postoperative nausea and vomiting when volatile agents are avoided.

Despite widespread clinical use of both techniques, the optimal choice of anaesthesia for outpatient TKA and THA remains uncertain. Much of the existing evidence comparing GA and SA is derived from retrospective observational studies and registry-based analyses. These studies often include mixed inpatient and outpatient populations and are subject to confounding by indication, as patients receiving GA frequently differ from those receiving SA with respect to comorbidity, functional status, or anticipated surgical complexity. As a result, it is difficult to determine whether observed differences in outcomes are attributable to the anaesthetic technique itself or to underlying patient characteristics. Randomized clinical trials specifically designed to compare GA and SA in the outpatient arthroplasty setting are scarce.

The GASPS (General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty) trial was designed to address this evidence gap. GASPS is a multicentre, randomized, phase IV clinical trial comparing GA and SA in adults undergoing outpatient primary TKA or THA. The overarching aim of the trial is to generate high-quality randomized evidence on whether the choice of anaesthetic technique influences the likelihood of successful same-day discharge and postoperative recovery in outpatient arthroplasty.

A total of 600 participants will be enrolled across multiple orthopaedic centres in Sweden. Eligible patients scheduled for outpatient primary TKA or THA are randomized on the day of surgery to receive either GA or SA. Randomization is performed using a stratified permuted block design, with stratification by type of surgery (knee or hip arthroplasty) and study site, to ensure balanced allocation across groups. Allocation concealment is maintained until shortly before surgery. Due to the nature of the interventions, blinding of patients and clinical staff is not feasible; however, data analysts remain blinded during analysis.

Both anaesthetic techniques are delivered according to standardized protocols that reflect contemporary routine clinical practice. General anaesthesia is provided using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil, administered by trained anaesthesiologists. Spinal anaesthesia is administered as a single-shot intrathecal block with bupivacaine, with optional intrathecal opioid adjuncts and light sedation as clinically indicated. No experimental drugs or procedures are introduced, and all perioperative care apart from the assigned anaesthetic technique follows local standard practice.

The primary outcome of the trial is successful same-day discharge, defined as discharge from hospital on the day of surgery without readmission within 48 hours. This outcome was chosen as a clinically meaningful and patient-relevant measure of perioperative success in outpatient arthroplasty, integrating both recovery efficiency and short-term safety. Successful same-day discharge reflects the combined effects of anaesthetic technique, surgical care, postoperative recovery, and early complication rates.

Secondary outcomes are designed to capture multiple dimensions of perioperative and postoperative recovery. These include perioperative time metrics related to anaesthesia induction, surgery, and recovery; early postoperative outcomes such as pain, nausea and vomiting, opioid consumption, mobilisation, and adverse events; and patient-reported outcomes assessing quality of recovery, function, and health-related quality of life. Recovery is conceptualized as a multi-phase process, ranging from early recovery in the postoperative care unit to longer-term recovery at home. Validated instruments such as the Quality of Recovery-15 (QoR-15), Knee injury and Osteoarthritis Outcome Score (KOOS), Hip disability and Osteoarthritis Outcome Score (HOOS), and EQ-5D-5L are used to assess these domains over time.

In addition to quantitative outcomes, the GASPS trial incorporates a qualitative component to explore patient experiences of anaesthesia and postoperative recovery. Semi-structured interviews are conducted with a subset of participants several weeks after surgery. This mixed-methods approach allows for a deeper understanding of patient perceptions, expectations, and experiences that may not be fully captured by standardized questionnaires, and provides important contextual information to complement clinical and patient-reported outcome data.

Participants are followed from the day of surgery up to 12 months postoperatively using a combination of medical record review and patient-completed questionnaires. Safety monitoring focuses on adverse events occurring in the immediate perioperative period, while longer-term follow-up captures functional outcomes, quality of life, healthcare utilization, and productivity losses. A health economic evaluation is embedded within the trial to compare GA and SA in terms of costs and quality-adjusted life years, with the aim of informing resource-efficient anaesthetic strategies for outpatient arthroplasty.

By integrating randomized clinical data, patient-reported outcomes, qualitative insights, and health economic analyses, the GASPS trial aims to provide a evaluation of the role of anaesthetic technique in outpatient total knee and hip arthroplasty.

Being tested
General Anaesthesia, Spinal Anesthesia (bupivacaine)
Keywords
Total Knee Arthroplasty, Total Hip Arthroplasty, Outpatient Surgery, Same-Day Discharge, Ambulatory Arthroplasty, General Anaesthesia, Spinal Anaesthesia, Neuraxial Anaesthesia, Total Intravenous Anaesthesia, Postoperative Recovery, Quality of Recovery, QoR-15, Postoperative Pain, Postoperative Nausea and Vomiting, PONV, Patient-Reported Outcomes, Health Economic Evaluation, Cost-Effectiveness, Randomized Clinical Trial
Medical subject headings
Pain, Postoperative, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General AnaesthesiaDrug

    Also called Total Intravenous Anaesthesia, TIVA, Propofol-Remifentanil Anaesthesia

    General anaesthesia is administered using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil. Anaesthesia is delivered intravenously using target-controlled or rate-controlled infusion systems according to routine clinical practice. Airway management and adjunct medications are provided as clinically indicated. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site.

  • Spinal Anesthesia (bupivacaine)Drug

    Also called Neuraxial Anaesthesia, Spinal Block, Intrathecal Anaesthesia

    Spinal anaesthesia is administered as a single-shot intrathecal injection of bupivacaine prior to surgery. Optional intrathecal opioid adjuncts, with fentanyl or sufentanil, may be used to enhance analgesia according to routine clinical practice. Light intravenous sedation may be provided if needed for patient comfort. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site.

Study groups in NCT07334132
Study groupRoleWhat they receive
General Anaesthesia (GA)ExperimentalParticipants randomized to this arm will receive general anaesthesia during outpatient primary total knee or total hip arthroplasty. General anaesthesia is administered using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil, delivered intravenously according to routine clinical practice. Perioperative care apart from the assigned anaesthetic technique follows standard clinical protocols at each study site.
Receives: Drug: General Anaesthesia
Spinal Anaesthesia (SA)ExperimentalParticipants randomized to this arm will receive spinal anaesthesia during outpatient primary total knee or total hip arthroplasty. Spinal anaesthesia is administered as a single-shot intrathecal injection of bupivacaine. Optional intrathecal opioid adjuncts and light intravenous sedation may be used at the discretion of the anaesthesiologist to ensure patient comfort. All other perioperative care follows standard clinical practice at each study site.
Receives: Drug: Spinal Anesthesia (bupivacaine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful Same-Day Discharge

    Successful same-day discharge is defined as discharge from the hospital on the day of surgery without readmission within 48 hours after discharge. Discharge readiness is assessed by the treating clinical team according to routine clinical criteria. Readmissions are identified through medical record review and patient follow-up.

    Measured: Day of surgery to 48 hours after discharge

Secondary outcomes (14)
  1. Time From Start of Anaesthesia to Start of Surgery

    Elapsed time from initiation of anaesthesia to the start of surgical incision, recorded intraoperatively.

    Measured: Day of surgery

  2. Time to Discharge From Post-Anaesthesia Care Unit (PACU)

    Time from the start of surgery to discharge from the postoperative recovery unit (Phase II), based on predefined discharge criteria.

    Measured: From intervention to time of discharge from PACU

  3. Time to Fulfilment of Hospital Discharge Criteria

    Time from the start of surgery to fulfilment of predefined criteria for discharge from hospital (Phase III), assessed by the clinical care team.

    Measured: During the hospital stay for surgery.

  4. Time to First Successful Mobilisation

    Time from the start of surgery to first successful mobilisation, defined as the ability to walk with tolerable pain, and to ascend or descend stairs if applicable.

    Measured: During the hospital stay for surgery.

  5. Opioid Consumption

    Postoperative opioid use converted to oral morphine equivalents (OME), recorded during hospital stay and reported by patients after discharge.

    Measured: Day of surgery to postoperative day 35

  6. Quality of Recovery (QoR-15)

    Patient-reported quality of postoperative recovery measured using the Quality of Recovery-15 (QoR-15) questionnaire.

    Measured: Postoperative day 1 to postoperative day 35

  7. Postoperative Pain

    Postoperative pain assessed using the Numeric Rating Scale (NRS) during hospital stay for surgery.

    Measured: Day of surgery to postoperative day 35

  8. Pain during recovery

    Pain, measured with items 11 and 12 of QoR-15 questionnarie

    Measured: Baseline and, postoperative day 1 to postoperative day 35

  9. Functional Outcome After Surgery

    Patient-reported functional outcomes assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee arthroplasty and the Hip disability and Osteoarthritis Outcome Score (HOOS) for hip arthroplasty.

    Measured: Baseline, 4 weeks, 6 months, and 12 months postoperatively

  10. Adverse Events and Serious Adverse Events

    Incidence, severity, and frequency of adverse events and serious adverse events related to the perioperative period.

    Measured: Start of anaesthesia to postoperative day 3

  11. Predefined adverse outcomes

    Incidence and frequency of predefined adverse outcomes.

    Measured: Day of surgery to 35 days postoperativly

  12. Blood transfusions

    Units of blood transfusesd

    Measured: During the hospital stay for surgery.

  13. Patient Experiences of Anaesthesia and Recovery

    Patient-reported experiences of anaesthesia and postoperative recovery explored through semi-structured qualitative interviews.

    Measured: 14 to 60 days after surgery

  14. Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)

    Incremental cost-effectiveness ratios (ICERs) comparing general anaesthesia and spinal anaesthesia, calculated as differences in total costs divided by differences in quality-adjusted life years (QALYs) gained. QALYs are derived from EQ-5D-5L measurements.

    Measured: Baseline to 12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07334132
Sponsor's protocol ID
GASPS
Other IDs
2024-520127-89-00
Acronym
GASPS
Status last verified
Dec 2025
First submitted
16 Dec 2025
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. JAMA. 2025 Jan 7;333(1):71-74. doi: 10.1001/jama.2024.21972.

    PubMed 39425955
  • Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. januari 2006;3(2):77-101.

  • Gibon E, Parvataneni HK, Prieto HA, Photos LL, Stone WZ, Gray CF. Outpatient total knee arthroplasty: is it economically feasible in the hospital setting? Arthroplast Today. 2020 Mar 13;6(2):231-235. doi: 10.1016/j.artd.2020.02.004. eCollection 2020 Jun.

    PubMed 32577469
  • Huang A, Ryu JJ, Dervin G. Cost savings of outpatient versus standard inpatient total knee arthroplasty. Can J Surg. 2017 Feb;60(1):57-62. doi: 10.1503/cjs.002516.

    PubMed 28234591
  • Churchill L, Pollock M, Lebedeva Y, Pasic N, Bryant D, Howard J, Lanting B, Laliberte Rudman D. Optimizing outpatient total hip arthroplasty: perspectives of key stakeholders. Can J Surg. 2018 Dec 1;61(6):370-376. doi: 10.1503/cjs.016117.

    PubMed 30265638
  • Kelly MP, Calkins TE, Culvern C, Kogan M, Della Valle CJ. Inpatient Versus Outpatient Hip and Knee Arthroplasty: Which Has Higher Patient Satisfaction? J Arthroplasty. 2018 Nov;33(11):3402-3406. doi: 10.1016/j.arth.2018.07.025. Epub 2018 Aug 1.

    PubMed 30143333
  • Gauthier-Kwan OY, Dobransky JS, Dervin GF. Quality of Recovery, Postdischarge Hospital Utilization, and 2-Year Functional Outcomes After an Outpatient Total Knee Arthroplasty Program. J Arthroplasty. 2018 Jul;33(7):2159-2164.e1. doi: 10.1016/j.arth.2018.01.058. Epub 2018 Feb 5.

    PubMed 29506929
  • Greimel F, Maderbacher G, Zeman F, Grifka J, Meissner W, Benditz A. No Clinical Difference Comparing General, Regional, and Combination Anesthesia in Hip Arthroplasty: A Multicenter Cohort-Study Regarding Perioperative Pain Management and Patient Satisfaction. J Arthroplasty. 2017 Nov;32(11):3429-3433. doi: 10.1016/j.arth.2017.05.038. Epub 2017 May 26.

    PubMed 28641966
  • Nilsson U, Jaensson M, Dahlberg K, Hugelius K. Postoperative Recovery After General and Regional Anesthesia in Patients Undergoing Day Surgery: A Mixed Methods Study. J Perianesth Nurs. 2019 Jun;34(3):517-528. doi: 10.1016/j.jopan.2018.08.003. Epub 2018 Nov 20.

    PubMed 30470465
  • Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.

    PubMed 19130163
  • Nilsson U, Gruen R, Myles PS. Postoperative recovery: the importance of the team. Anaesthesia. 2020 Jan;75 Suppl 1:e158-e164. doi: 10.1111/anae.14869.

    PubMed 31903575
  • Allvin R, Berg K, Idvall E, Nilsson U. Postoperative recovery: a concept analysis. J Adv Nurs. 2007 Mar;57(5):552-8. doi: 10.1111/j.1365-2648.2006.04156.x.

    PubMed 17284272
  • Calkins TE, Johnson EP, Eason RR, Mihalko WM, Ford MC. Spinal Versus General Anesthesia for Outpatient Total Hip and Knee Arthroplasty in the Ambulatory Surgery Center: A Matched-Cohort Study. J Arthroplasty. 2024 Jun;39(6):1463-1467. doi: 10.1016/j.arth.2023.12.020. Epub 2023 Dec 15.

    PubMed 38103803
  • Keulen MHF, Asselberghs S, Boonen B, Hendrickx RPM, van Haaren EH, Schotanus MGM. Predictors of (Un)successful Same-Day Discharge in Selected Patients Following Outpatient Hip and Knee Arthroplasty. J Arthroplasty. 2020 Aug;35(8):1986-1992. doi: 10.1016/j.arth.2020.03.034. Epub 2020 Mar 27.

    PubMed 32307291
  • Gazendam AM, Tushinski D, Patel M, Bali K, Petruccelli D, Winemaker M, DeBeer J, Gillies L, Best K, Fife J, Wood TJ. Causes and predictors of failed same-day home discharge following primary hip and knee total joint arthroplasty: a Canadian perspective. Hip Int. 2023 Jul;33(4):576-582. doi: 10.1177/11207000221111101. Epub 2022 Jul 17.

    PubMed 35848135

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing General Anaesthesia and Spinal Anesthesia (bupivacaine) in people with Osteo Arthritis Knee and Hip and Osteo Arthritis, run by Region Örebro County.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erik Noppa, MD (+46 19-602 03 15, erik.noppa@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Same-Day Discharge (time frame: Day of surgery to 48 hours after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07334132, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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