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

NCT07334132 | Not Yet Recruiting Phase 4

• 2 other identifiers: GASPS2024-520127-89-00
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Osteo Arthritis Knee and Hip; Osteo Arthritis; Inflammatory Joint Disease (IJD)

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

Outcome Measures

Primary Outcomes (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.

  Day of surgery to 48 hours after discharge

Secondary Outcomes (14)

• Time From Start of Anaesthesia to Start of Surgery

  Day of surgery

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

  From intervention to time of discharge from PACU

• Time to Fulfilment of Hospital Discharge Criteria

  During the hospital stay for surgery.

• Time to First Successful Mobilisation

  During the hospital stay for surgery.

• Opioid Consumption

  Day of surgery to postoperative day 35

Study Arms (2)

General Anaesthesia (GA)

EXPERIMENTAL

Participants 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.

Drug: General Anaesthesia

Spinal Anaesthesia (SA)

EXPERIMENTAL

Participants 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.

Drug: Spinal Anesthesia (bupivacaine)

Interventions

General Anaesthesia DRUG

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.

Also known as: Total Intravenous Anaesthesia, TIVA, Propofol-Remifentanil Anaesthesia

General Anaesthesia (GA)

Spinal Anesthesia (bupivacaine) DRUG

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.

Also known as: Neuraxial Anaesthesia, Spinal Block, Intrathecal Anaesthesia

Spinal Anaesthesia (SA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator
• Region Skane: collaborator

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MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Anesthesia, General; Anesthesia, Spinal; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Erik Noppa, MD

CONTACT

+46 19-602 03 15; erik.noppa@oru.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This trial uses a partial blinding strategy to minimise bias while accommodating the practical requirements of the interventions. Participants and clinical staff involved in preoperative care will be blinded to the assigned anaesthesia method until a few hours prior to surgery. The anaesthesia team responsible for administering the allocated intervention will not be blinded, as they must deliver the specific anaesthetic technique (GA or SA). Outcome assessors will not be blinded, as their interactions with participants and the nature of the postoperative evaluations (e.g., assessing sensory or motor blockade) may reveal the anaesthetic technique. To reduce potential bias, all assessors will follow standardised assessment protocols. Data analysts will remain blinded to the treatment allocation during the analysis phase.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 12, 2026

Record last verified: 2025-12