Comparison of different routes of administration of Clonidine as an adjuvant For Post-operative analgesia following Anterior Cruciate Ligament Repair
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- to assess duration of analgesia (time till Visual Analogue Score more than 3)
研究概览
简要总结
Anterior Cruciate Ligament (ACL) Repair is one of the most common orthopaedic sports surgeries today. Post-operative pain is the most common complication that delays early ambulation and patient discharge, thereby increasing hospitalization costs as well. Therefore, effective postoperative analgesia is of great significance.
ACL surgeries are now commonly done under regional anaesthesia i.e. neuraxial or peripheral nerve blocks using local anaesthetics.
Several adjuvants have been used to further prolong the analgesic duration of local anaesthetic agents in the above methods like Clonidine, Dexamethasone.
Clonidine not only has analgesic properties but also extends the action of local anaesthetics, reducing the required analgesic dose and helping prevent local toxicity at the injection site.
In this study we evaluated different routes of administering Clonidine as an adjuvant for prolonging post-operative analgesia in patients undergoing ACL surgeries.
33 patients of either sex, in age group of 18-75 years posted ACL repair surgeries were randomly divided into 3 groups of 11 each,
•Group SC (Standard Care Group) which received plain intrathecal block.
•Group IT (Intrathecal Clonidine Group) which received intrathecal block with clonidine as adjuvant.
•Group NB (Nerve Block with Clonidine Group) which received clonidine as adjuvant in Adductor canal block (ACB) in addition to plain intrathecal block.
Post block patients were evaluated for duration of analgesia and duration of sensory and motor blockade.
This study demonstrates that Clonidine, when used as an adjuvant, significantly prolongs postoperative analgesia in both intrathecal and peripheral block routes.
Notably, it demonstrates greater efficacy in Peripheral Nerve Blocks compared to the intrathecal route.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •18-75 years aged patients BMI 20-35 kg/m2 ASA I – II Availability of written informed consent Hemodynamically stable patients with all routine investigations within normal limits.
- •Patients undergoing arthroscopic ACL repair.
排除标准
- •Patient unwilling to get enrolled in the study.
- •Allergy to the study drugs.
- •Patient with pre-op Heart rate 45 beats/min or less.
- •Patient on recent oral opioids in last 3 months.
- •Patients in whom the nerve block could not be performed as per methodology Patients with contraindications to Spinal Anaesthesia Pregnancy Any cognitive dysfunction or psychiatric disorders Patient with heart diseases like congestive heart failure, coronary heart disease, any degree of tract block.
- •Patient with renal insufficiency or liver impairment.
- •Patient with coagulopathy.
- •Patient with neuropathy.
结局指标
主要结局
to assess duration of analgesia (time till Visual Analogue Score more than 3)
时间窗: measuring visual analogue scores (VAS) immediately post block every 15 mins in the first hour followed by every 2 hours post block for first 6 hours, then every 6 hours till VAS more than three
次要结局
- to assess pain score post operatively(measuring visual analogue pain scores immediately post block till twenty-four hours post block)
- duration of sensory blockade(measuring skin prick scores from immediately post block till score of two achieved (till return of sensation at knee joint))
- duration of motor block(measuring modified Bromage score from immediately post block till score of four achieved (ability to flex knee joint))
- sedation(measure ramsay sedation scores at 15 minute intervals till baseline levels achieved)
- patient satisfaction score(measured at twenty-four hours post block)
研究者
Dr Grace Mammen
Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune