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Analgesia effect of premixed nitrous oxide/oxygen during the rehabilitation after total knee arthroplasty: a study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The morbidity of knee arthritis is increasing among aged people and total knee arthroplasty has been its mainstream treatment to date. Postoperative rehabilitation is an important part of the procedure. However, the intense pain during the functional exercise involved has always been a challenge for both patients and health care professionals. The aim of this study is to test the analgesic effect of a mixture of nitrous oxide/oxygeb (1:1) inhalation for patients who are doing functional exercise 1 month after total knee arthroplasty. METHODS/DESIGN:This double-blind, randomized, placebo-controlled study will be implemented in the Rehabilitation Department in the General Hospital of Ningxia Medical University. Patients aged between 50 and 75 years who underwent a primary unilateral total knee arthroplasty are eligible for inclusion. The key exclusion criteria include: epilepsy, pulmonary embolism, intestinal obstruction, aerothorax. The treatment group (A) will receive a pre-prepared nitrous oxide/oxygen mixture plus conventional treatment (no analgesics), and the control group (B) will receive oxygen plus conventional treatment (no analgesics). Patients, physicians, therapists, and data collectors are all blind to the experiment. Assessments will be taken immediately after functional exercise begins (T0), 5 min (T1) after functional exercise begins, and 5 min after functional exercise has finished (T2). Patients will be randomly allocated between a treatment group (A) and a control group (B) in a ratio of 1:1. Primary outcome, including pain severity in the procedure, will be taken for each group. Secondary outcomes include blood pressure, heart rate, oxygen saturation, side effects, knee joint range of motion, Knee Society Score (KSS), rescue analgesia need, and satisfaction from both therapists and patients. DISCUSSION:This study will focus on exploring a fast and efficient analgesic for patients who are doing functional exercise after total knee arthroplasty. Our previous studies suggested that the prefixed nitrous oxide/oxygen mixture was an efficacious analgesic for the management of burn-dressing pain and breakthrough cancer pain. The results of this study should provide a more in-depth insight into the effects of this analgesic method. If this treatment proves successful, it could be implemented widely for patients doing functional exercise in the rehabilitation department. TRIAL REGISTRATION:ChiCTR-INR-17012891 . Registered on 6 October 2017.

SUBMITTER: Dai YL

PROVIDER: S-EPMC6610947 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionTotal knee arthroplasty (TKA) surgery causes postoperative pain. The use of perioperative injections around the knee containing local anaesthetic, opiates and non-steroidal anti-inflammatory drugs has increased in popularity to manage pain. Theoretical advantages include reduced requirements for analgesia and earlier mobilisation. We propose a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration versus femoral nerve anaesthetic blockade as analgesia for TKA. The aim is to determine, in patients undergoing TKA, if there is a difference in patient-reported pain scores on the visual analogue scale (VAS) prior to physiotherapy on day 1 postoperatively between treatment groups.Methods and analysisPatients undergoing a primary unilateral TKA at University Hospitals Coventry and Warwickshire Hospitals will be assessed for eligibility. A total of 264 patients will provide 90% power to detect a difference of 12 mm on the VAS on day 1 postoperatively at the 5% level. The trial will use 1:1 randomisation, stratified by mode of anaesthetic. Primary outcome measure will be the VAS for pain prior to physiotherapy on day 1. Secondary outcome measures include VAS on day 2, total use of opiate analgesia up to 48 h, ordinal pain scores up to 40 min after surgery, independent functional knee physiotherapist assessment on days 1 and 2. Oxford knee Scores (OKS), EuroQol (EQ-5D) and Douleur Neuropathic Pain Scores (DN2) will be recorded at baseline, 6 weeks and 12 months. Adverse events will be recorded up to 12 months. Analysis will investigate differences in VAS on day 1 between the two treatment groups on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are less than 0.05.Ethics and disseminationNRES Committee West Midlands, 23 September 2013 (ref: 13/WM/0316). The results will be disseminated via peer-reviewed publications and conference presentations.Trial registration numbersISRCTN 60611146 and EUDRACT Number 2013-002439-10 (protocol code number PAKA-33601-AS117013); Pre-results.

Project description:BackgroundPostoperative pain after total knee arthroplasty (TKA) can cause negative emotions, such as anxiety and depression, which can severely affect a patient's long-term quality of life.ObjectiveThis study aimed to investigate the impact of multimodal analgesia (MMA) on postoperative anxiety and depression following total knee arthroplasty.MethodsThis study included 161 patients who underwent TKA from October 2020 to October 2022 in the First Affiliated Hospital of Wannan Medical College, including 79 cases in the control group and 82 cases in the multimodal analgesia group (MMA). The MMA group were administered acetaminophen 0.5 g/d orally 3 days before the surgery, and an ultrasound-guided fascia iliac compartment block (FICB) with 0.25% ropivacaine 30 ml in the inguinal region ipsilateral to the surgery was performed 1 h before surgery. After the surgery, 100 ml solution includes 100 mg ropivacaine, 2.5 mg morphine, and 0.25 mg epinephrine for intra-articular and periarticular injection. Postoperative conventional intravenous analgesia was used in the control group, including 100 mg ropivacaine, 2.5 mg morphine, and 0.25 mg epinephrine for intra-articular and periarticular injection. Patients were scored for pain, anxiety, and depression in the ward at 3 and 7 days postoperatively, and postoperative patients were scored using telephone callbacks at 3 months postoperatively.ResultsIt was found that the visual analog scale (VAS) scores for pain at rest at 3 days, 7 days, and 3 months postoperatively were significantly lower in the MMA group than in the control group (P < 0.05). The scores for pain with movement were significantly lower in the MMA group than in the control group at 3 days and 7 days postoperatively (P < 0.01), but they were similar at 3 months postoperatively. Compared to the control group, the MMA group had significantly higher American Knee Society scores (AKS) at 3 days, 7 days, and 3 months postoperatively (P < 0.05). Compared to the control group, the MMA group had significantly higher Lower Extremity Functional Scale and Hospital Anxiety and Depression Scale scores (HADS) (P < 0.05) at 3 days and 7 days postoperatively; compared to the control group, the MMA group had a significantly shorter hospital stay (P < 0.01).ConclusionMultimodal analgesia can alleviate postoperative anxiety and depression in the short term, reduce perioperative pain, improve postoperative recovery, and shorten the length of hospital stay.

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Analgesia effect of premixed nitrous oxide/oxygen during the rehabilitation after total knee arthroplasty: a study protocol for a randomized controlled trial.

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