TRANSDERMAL FENTANYL AS A FORM OF REBOUND PAIN REDUCTION IN FAST TRACK PROGRAMME IN PRIMARY KNEE ARTHROPLASTY. Prospective Observational Non-inferiority Study Versus Morphine PCA.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 主要终点
- - Responders to the decrease in the rate of "rebound pain" with the use of transdermal fentanyl patch relative to morphine PCA:
研究概览
简要总结
Total knee arthroplasty is a common surgery in routine clinical practice that, although it achieves an improvement in the functionality and quality of life of patients, it causes intense postoperative pain. In this regard, locoregional block techniques are commonly used for the immediate postoperative period. However, these techniques have the disadvantage of being of limited duration and the appearance of so-called "rebound pain" when their effect wears off. To counteract this problem and maintain adequate analgesic control over a longer period of time, the use of a transdermal fentanyl patch seems to be a good option, with advantages over the traditional approach of placing a morphine PCA.
Specifically, the aims of the study are: the evaluation of the decrease in the rate of rebound pain after locoregional techniques using a transdermal fentanyl patch after primary knee arthroplasty, as well as the evaluation of non-inferiority in terms of functional recovery, analgesic efficacy and adverse effects compared to morphine PCA.
Methods: This will be a prospective observational cohort study, with a total N of 106 patients undergoing total knee arthroplasty who meet the study inclusion criteria. The numerical pain rating scale score will be collected at 6,8,12,24 and 26h from which the "rebound pain score" will be calculated. The need for pharmacological rescue will be assessed as well as the appearance of adverse effects at 12, 24 and 36h and finally the QoR15 scale will be assessed at 36h.
详细描述
Total knee arthroplasty (TKA from now on) is a frequent surgery in routine clinical practice in constant evolution and improvement, with the objective being the earliest possible functional recovery of these patients, the role of the anaesthesiologist being fundamental in this sense throughout the perioperative period since, as we know, it is a surgery that improves the mobility and quality of life of the patient, but causes intense postoperative pain during the first 24 to 72 hours, it is a surgery that improves the patient's mobility and quality of life, but causes intense postoperative pain during the first 24 to 72 hours, a very important factor to take into account in these patients since it is known that adequate postoperative pain control promotes ambulation and the possibility of physiotherapy for the patient, This leads to an early recovery, a lower rate of complications (such as deep vein thrombosis or nosocomial infection) and a shorter hospital stay, allowing the strategy known as "fast-track" to be carried out, which would consist of achieving functional recovery and discharge as early as possible, this being the current trend in management by most trauma teams dedicated to this field, since it results in a decrease in morbidity and greater patient satisfaction. In relation to this approach, as has been mentioned, multiple studies have shown that one of the main causes of delayed hospital discharge is poor pain control and mobilisation problems.
Therefore, adequate postoperative pain control will be important in this surgery. This control could be achieved with a combination of locoregional techniques such as peripheral nerve blocks of the adductor canal (BCA) and the so-called "Infiltration between the Popliteal Artery and the Capsule of the Knee" (IPACK) together with conventional analgesia such as NSAIDs, paracetamol, metamizole and, if this is not sufficient, opioids.
The locoregional techniques mentioned (BCA + IPACK) have demonstrated their efficacy in controlling immediate postoperative pain in this type of surgery in multiple studies. The first of these, BCA, provides analgesia in the anteromedial area of the knee, avoiding the femoral nerve block with the consequent weakness of the quadriceps. The second of these, IPACK, is a relatively novel technique described to achieve analgesia in the posterior capsule of the knee that is achieved by blocking the popliteal plexus formed by the articular sensory branches of the tibial and obturator nerves arranged around the popliteal artery and vein without involving the motor branches of the tibial and peroneal nerves, avoiding the motor block resulting from performing a block of the sciatic nerve at the popliteal level.
From all of the above, we can deduce that both techniques are effective individually, but even more so, as is logical, in combination, allowing the entire joint territory to be covered with the least possible impairment of motor function, which will be of particular relevance in terms of starting the patient's mobilisation earlier, which is definitely an advantage over traditional femoral and sciatic nerve block techniques.
However, the duration of nerve blocks is less than 24h, which is a problem, since the period of maximum incidence of postoperative pain has not yet been completed and it is possible that just at this time (12-24h after the block, when the effect of the block ends) what is known as "rebound pain" may appear, considered a possible adverse effect of peripheral nerve blocks that is becoming increasingly important, as studies dedicated to its study emerge.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 否
入选标准
- •All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy
排除标准
- •Prior opioid treatment.
- •History of previous opioid adverse effects.
- •History of PONV.
- •History of medical history that conditions baseline alteration of the data to be collected.
- •Contraindication to neuroaxial techniques.
- •Difficulty in understanding the scales used.
- •Patient's refusal.
结局指标
主要结局
- Responders to the decrease in the rate of "rebound pain" with the use of transdermal fentanyl patch relative to morphine PCA:
时间窗: 6,8,12,24 and 36hours after the lock
- Rebound pain score (RPS): Defined as the result of subtracting the minimum score on the pain scale the first 12 hours before the end of action of the peripheral blockade from the maximum score on the pain scale the first 12 hours after the disappearance of the action of the peripheral blockade. To calculate this variable, the numerical pain scale score will be collected 6, 8, 12, 24 and 36 hours after the peripheral nerve block.
次要结局
- non-inferiority of PFT vs PCA morphine in terms of early postoperative recovery:(48 hours in the postoperative period)
- non-inferiority of PFT vs. morphine PCA in terms of post-surgical analgesia:(48 hours in the postoperative period)
- non-inferiority of PFT vs morphine PCA in terms of adverse effects:(48 hours in the postoperative period)
研究者
Oscar Diaz-Cambronero
MÉDICO ADJUNTO ANESTESIOLOGÍA
Hospital Universitario La Fe
