Analgesic Efficacy of Ropivacaine Alone or in Combination With Adjuvants on Post-operative Analgesia Following Video-Assisted Thoracoscopic Surgery (VATS) - A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
The aim of the study is to investigate the analgesic effects of the subcutaneous wound infiltration with tramadol, ketamine, dexamethasone, dexmedetomidine and midazolam as adjuvant to ropivacaine, compared to ropivacaine alone in patients undergoing Video-Assisted thoracoscopic Surgery (VATS) procedures.
详细描述
After obtaining approval from Ethical Review Committee (ERC) of Aga Khan University Hospital Karachi (AKUH), and inform about the study to primary surgeon, informed written consent will be obtained from the patients fulfilling the inclusion criteria.
Patients will be recruit in the study during the preoperative anesthesia evaluation either at the preoperative clinic or from the ward after admission. Their Medical Record (MR) number will be send to the Clinical Trials Unit (CTU), along with their expect date, day and timing of surgery. The CTU will randomly allocate the patients to one of the six groups, based on computer generated allocation. After the patient will reach the preoperative area in the operating room (OR), an email request will be generated to the CTU who will release the prepared study drug syringe and will send it to the Principal Investigator (PI). The syringe contain either Ropivacaine alone or in combinations with other adjuvants. The drugs for all six groups looks alike, so that the patient, principal investigator, and surgeon administering the drugs or making observations will all blinded.
Group A: Patients will receive subcutaneous wound infiltration with 24ml of 0.25% Ropivacaine in three divided doses (i.e. 8 mL per incision) (control group). Total dose of Ropivacaine will be 60 mg.
Group B: Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 1mg/kg ketamine (8 mL per incision) (ketamine group).
Group C: Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 2mg/kg tramadol (8 mL per incision) (Tramadol group).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I to III.
- •Age >18 years.
- •Either sex.
- •Elective Video assisted thoracotomy surgery (VATS) under general anaesthesia
排除标准
- •ASA IV & V.
- •Coagulation disorders.
- •Infection at the vicinity of the surgical wound.
- •Raised intracranial pressure.
- •History of hypersensitivity or known allergy to any study drug.
- •History of opioid addiction.
- •History of seizure disorder.
- •Those who are not willing to participate in the study.
- •Allergy to local anesthetics.
- •Duration of surgery greater than 2 hours.
研究组 & 干预措施
Ropivacaine with Ketamine
Ropivacaine is a propyl analog of bupivacaine with longer duration of action with much safer cardiotoxicity profile than bupivacaine. Ropivacaine has the same analgesic effects as bupivacaine and levobupivacaine, but it is associated with a low incidence of motor block. Thus, ropivacaine appears to be an important component for local anesthesia and postoperative analgesia.
Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist that possesses both central and peripheral analgesic effects. Preincisional infiltration of ketamine prolongs the time to first analgesic requirement and also decreases the total amount of analgesics used postoperatively.
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 1mg/kg ketamine (8 mL per incision) (ketamine group).
干预措施: Ropivacaine + Ketamine (Drug)
Ropivacaine with Tramadol
Tramadol hydrochloride is a synthetic analog of codeine that acts on both opioid (weak mu receptor agonist) and nonopioid receptors (inhibits reuptake of nor-adrenaline and serotonin as well as release stored serotonin from nerve endings) which play a crucial role in pain inhibition pathway.
It also blocks nerve conduction which imparts its local anesthetics like action on peripheral nerves.
In one study it was found that the addition of tramadol or midazolam to caudal epidural ropivacaine prolongs the duration of analgesia without causing significant side effects.
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 2mg/kg tramadol (8 mL per incision) (Tramadol group).
干预措施: Ropivacaine + Tramadol (Drug)
Ropivacaine with Midazolam
The analgesic effect of extradurally administered midazolam is through γ-amino butyric acid (GABA)/benzodiazepine system of spinal cord.
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 50 μg/kg midazolam (8 mL per incision) (Midazolam group).
干预措施: Ropivacaine + Midazolam (Drug)
Ropivacaine with Dexamethasone
The glucocorticoid dexamethasone appears to be effective in a small number of preclinical and clinical studies and found that dexamethasone prolongs analgesia from interscalene blocks using ropivacaine or bupivacaine, with the effect being stronger with ropivacaine.
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine+ 8mg dexamethasone (8 mL per incision) (Dexamethasone group).
干预措施: Ropivacaine + Dexamethasone (Drug)
Ropivacaine with Dexmedetomidine
Dexmedetomidine is a new highly selective alpha2 (a2) agonist with known sedative, antihypertensive, anxiolytic, and analgesic properties.
In one study, it was found that wound infiltration with combined ropivacaine and dexmedetomidine found to be significantly superior for postoperative analgesia compared with either combined ropivacaine and tramadol or ropivacaine alone for lumbar discectomies.
Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% Ropivacaine + 0.5μg/kgdexmedetomidine (8mL per incision) (Dexmedetomidine group).
干预措施: Ropivacaine + Dexmedetomidine (Drug)
Ropivacaine
Ropivacaine is a propyl analog of bupivacaine with longer duration of action with much safer cardiotoxicity profile than bupivacaine. Ropivacaine has the same analgesic effects as bupivacaine and levobupivacaine, but it is associated with a low incidence of motor block. Thus, ropivacaine appears to be an important component for local anesthesia and postoperative analgesia.
Patients will receive subcutaneous wound infiltration with 24ml of 0.25% Ropivacaine in three divided doses (i.e. 8 mL per incision) (control group). Total dose of Ropivacaine will be 60 mg.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: Follow till 24 hours postoperatively
Assessement for Postoperative Pain. The requirement of postoperative analgesia of the patient will be evaluated by using Visual analogue scale (VAS). It scored from 0 to 10 (where 0 \[minimum score\] = no pain and 10 \[maximum score\] = worst pain). Aggregate score will be added. Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. This score is just a numerical number with no other value attached to it.
Time to the first postoperative analgesia requirement
时间窗: Follow till 24 hours postoperatively
Time to the first analgesic requirement will be calculated as the time from the performance of local wound infiltration to the first analgesic dose administered. This time will be noted in minutes.
次要结局
- Sedation using Pasero Opioid-Induced Sedation Scale (POSS)(Follow till 24 hours postoperatively)
研究者
Dr. Muhammad Saad Yousuf
Principal Investigator
Aga Khan University