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临床试验/NCT07334132
NCT07334132尚未招募4 期

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

Region Örebro County0 个研究点目标入组 600 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
600
主要终点
Successful Same-Day Discharge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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:
  • Ability to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures.

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: General Anaesthesia (Drug)

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.

干预措施: Spinal Anesthesia (bupivacaine) (Drug)

结局指标

主要结局

Successful Same-Day Discharge

时间窗: Day of surgery to 48 hours after 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.

次要结局

  • Time From Start of Anaesthesia to Start of Surgery(Day of surgery)
  • Time to Fulfilment of Hospital Discharge Criteria(During the hospital stay for surgery.)
  • Opioid Consumption(Day of surgery to postoperative day 35)
  • Time to Discharge From Post-Anaesthesia Care Unit (PACU)(From intervention to time of discharge from PACU)
  • Time to First Successful Mobilisation(During the hospital stay for surgery.)
  • Quality of Recovery (QoR-15)(Postoperative day 1 to postoperative day 35)
  • Postoperative Pain(Day of surgery to postoperative day 35)
  • Pain during recovery(Baseline and, postoperative day 1 to postoperative day 35)
  • Functional Outcome After Surgery(Baseline, 4 weeks, 6 months, and 12 months postoperatively)
  • Adverse Events and Serious Adverse Events(Start of anaesthesia to postoperative day 3)
  • Predefined adverse outcomes(Day of surgery to 35 days postoperativly)
  • Blood transfusions(During the hospital stay for surgery.)
  • Patient Experiences of Anaesthesia and Recovery(14 to 60 days after surgery)
  • Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)(Baseline to 12 months postoperatively)

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Sponsor

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