A comparative study of addition of two different doses of tramadol to ropivacaine for wound infiltration in spine surgeries on postoperative analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The primary outcome variable will be determined as the time to first analgesic administration by recording numerical rating scale every hour postoperatively after infiltration of the study drug.
研究概览
简要总结
Wound infiltration by local anaesthetics has become increasinglycommon for postoperative analgesia owing to its simplicity, safety andeffectiveness and its provision of effective postoperative analgesia, particularlyafter surgical procedures. TramadolHydrochloride is a synthetic analogue of codeine when added as an adjuvant tolocal anaesthetic agents, causes an effect similar to that of clonidine and itcan modify the effects of local anaesthetics by directly or indirectlyeffecting sodium channels, thus contributing to more effective analgesia. Combinationof ropivacaine and tramadol for wound infiltration after spine surgeries mayprovide superior analgesic effects compared with the sole administration of ropivacainethrough the same route. However the optimum dose of tramadol as an adjuvant hasnot been defined conclusively. The present study is aim to assess the analgesicefficacy of two different doses of tramadol added to ropivacaine for woundinfiltration in spine surgeries.
Patients will be randomized to receive their study drugs after thespinal surgery and before closing the incision line .The study drug as pergroup allocation will be injected over the incision line on the paravertebralmuscles, cutaneous and subcutaneous tissue with equal volume on either sides.This will be followed by reversal of residual neuro-muscular block and aftermeeting extubation criteria patient will be extubated and shifted to recoveryroom.
Post operatively pulse rate , blood pressure, respiratory rate, oxygensaturation , numerical rating score(NRS), sedation score will be monitoredevery hourly till the patient complains of pain or NRS > or equal to 4.Level of sedation will be assessed by Ramsay sedation score.
Time to first analgesic requirement will be the time since woundinfiltration done to the time when the patient complains of pain or NRS > orequal to 4. At that time patients will be administered additional analgesiawith inj fentanyl 1mcg/kg IV. Postoperatively all patients will be given injparacetamol 15mg/kg IV every 6th hourly.
Post operatively patients will be monitored for adversecardiovascular and respiratory event, nausea, vomiting and any other sideeffects will be noted within 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients belonging to American society of Anesthesiologists physical status grade I and II 2)Age between 18 to 60 years.
排除标准
- •Allergy to any of study drugs.
- •Patients on treatment with chronic opioids or study drugs.
- •Who have cardiovascular, pulmonary, renal, neurological and metabolic diseases.
- •Inability to comprehend numerical rating scale.
- •Who undergo cervical spine surgeries.
- •Pregnant and lactating mothers.
结局指标
主要结局
The primary outcome variable will be determined as the time to first analgesic administration by recording numerical rating scale every hour postoperatively after infiltration of the study drug.
时间窗: Time frame 24 hours after surgery
次要结局
- Any adverse effects observed with ropivacaine and tramadol will be determined as secondary outcome(Time frame 24 hours after surgery)