The Efficacy of Local Infiltration Analgesia for Postoperative Pain Management and Functional Recovery After Total Knee Arthroplasty: Peripheral Nerve Blocks With and Without Local Infiltration Analgesia
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in postoperative pain intensity and pain control: VAS pain scale
研究概览
简要总结
This prospective, double-blinded, randomized controlled study evaluates the effects of peripheral nerve blocks with and without local infiltration analgesia for postoperative pain management after primary total knee arthroplasty. There are no any studies that show the demand for local infiltration analgesia when together peripheral nerve blocks are performed. Patients undergoing primary total knee arthroplasty will be randomly assigned to receive local infiltration analgesia with or without (placebo group) local anesthetic. All patients will receive peripheral nerve blocks for postoperative analgesia: femoral triangle and distal adductor canal blocks. Comparison of these two groups of patients will be based on the effects on postoperative pain control, the extent of motor blockade, the ability of early leg motion and ambulation, patients satisfaction rates over the time of clinical recovery.
Consequently, the investigators hypothesized that peripheral nerve blocks (femoral triangle and distal adductor canal blocks) with and without local infiltration analgesia provide similar postoperative pain relieving effects and the ability of early mobilization after total knee arthroplasty.
详细描述
The aim: to evaluate peripheral nerve blocks with and without local infiltration analgesia regarding the postoperative analgesic efficacy, the ability of early motion and ambulation in patients following primary total knee arthroplasty.
Primary Hypothesis: peripheral nerve blocks with (LIA+) and without (LIA-) local infiltration analgesia provide similar postoperative pain relieving effects after primary total knee arthroplasty.
Secondary Effects: peripheral nerve blocks with (LIA+) and without (LIA-) local infiltration analgesia provide similar ability to recover after primary total knee arthroplasty.
The objectives:
- To compare postoperative pain control effects between LIA+ and LIA- groups of patients after primary total knee joint replacement surgery.
- To assess the ability of early motion and ambulation after total knee joint replacement surgery between the LIA+ and LIA- groups.
- To estimate opioid consumption and its adverse effects in LIA+ and LIA- groups of patients after primary total knee arthroplasty.
- To compare the patient's postoperative satisfaction rates in LIA+ and LIA- groups of patients after primary total knee arthroplasty.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary unilateral total knee arthroplasty under spinal anaesthesia;
- •Age 18 - 90 years;
- •Patients conformed to American Society of Anaesthesiologists (ASA) physical status I-III in preoperative assessment;
- •Ability to follow the study protocol.
排除标准
- •Inability or refusal to follow the study protocol.
- •American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
- •Coagulopathy.
- •Pre-exiting lower extremity neuromuscular disorders.
- •Local infection over injection site.
- •Allergy or contraindications to the drugs used in the study (local anesthetics, NSAIDs, opioids).
- •Chronic opioid use.
- •Other type of anesthesia.
研究组 & 干预措施
Local infiltration analgesia without local anesthetic (LIA-)
Local infiltration analgesia will be performed at the end of the surgery by injection of 0.3 mg of epinephrine and 120 ml of normal saline.
干预措施: Solution without local anesthetic (Drug)
Local infiltration analgesia with local anesthetic (LIA+)
Local infiltration analgesia will be performed at the end of the surgery by injection of 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline.
干预措施: Local infiltration analgesia with local anesthetic (Procedure)
Local infiltration analgesia with local anesthetic (LIA+)
Local infiltration analgesia will be performed at the end of the surgery by injection of 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline.
干预措施: Needle (Device)
Local infiltration analgesia with local anesthetic (LIA+)
Local infiltration analgesia will be performed at the end of the surgery by injection of 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline.
干预措施: Solution with local anesthetic (Drug)
Local infiltration analgesia without local anesthetic (LIA-)
Local infiltration analgesia will be performed at the end of the surgery by injection of 0.3 mg of epinephrine and 120 ml of normal saline.
干预措施: Local infiltration analgesia without local anesthetic (Procedure)
Local infiltration analgesia without local anesthetic (LIA-)
Local infiltration analgesia will be performed at the end of the surgery by injection of 0.3 mg of epinephrine and 120 ml of normal saline.
干预措施: Needle (Device)
结局指标
主要结局
Changes in postoperative pain intensity and pain control: VAS pain scale
时间窗: First 48 hours after primary total knee arthroplasty.
Postoperative pain will be assessed in both groups using the visual analogue scale (VAS). The VAS pain scale (numerical rating scale) consists of a range from 0 (no pain) to 10 (worst imaginable pain). Higher score indicate greater pain intensity. Interpretation: 0 (no pain); 1-3 (mild pain); 4-6 (moderate pain); 7-10 (severe pain). Pain control will be assessed at rest, during active and passive 45 degree knee flexion at 3, 6, 24, 48 hours after the surgery.
次要结局
- Postoperative ability of early ambulation.(First 48 hours after primary total knee arthroplasty.)
- Extent of motor blockade.(First 48 hours after primary total knee arthroplasty.)
- Rate of patients satisfaction: 10 point scale(First 48 hours after primary total knee arthroplasty.)
- Opioid consumption.(First 48 hours after primary total knee arthroplasty.)
- Number of participants with postoperative complications.(First 48 hours after primary total knee arthroplasty.)
研究者
Inna Jaremko
Principal Investigator
Lithuanian University of Health Sciences