Comparision of Post-operative pain using VAS and Analgesia requirement among Diabetic and Non-Diabetic patients undergoing Total Laparoscopic Hysterectomy Surgery. A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Comparision of Pain using VAS in Diabetic and Non-Diabetic patients for 24 hours post Total Laparoscopic Hysterectomy Surgery
研究概览
简要总结
Group N is Non Diabetic Patients
Group D is Diabetic Patients
All Patients to be subjected to complete Pre-anaesthetic checkup. In Diabetic patients, Type of Diabetes, Duration of disease, Present Status of Disease, Complications (if any) to be recorded.
All Patients to be subjected to routine investigations. Glycosylated Haemoglobin (HbA1c) to be done in all patients included in the study.
Patients on OHA were shifted to Inj. Regular Insulin peri-operatively according to physicians advice.
Patients were kept NPO as per guidelines.
On arrival in OT,
Intravenous access is established with 20G IV Cannula. Inj RL started at the rate of 80ml per hour.
Standard monitors with pulse oximeter, NIBP, ECG , End tidal carbon di oxide line attached and parameters noted.
After pre-oxygenation with 100 percentage oxygen, GA to be administered with Inj Fentanyl 2mcg per kg, Inj Propofol 1.5 mg per kg, Inj Rocuronium 0.6 mg per kg after checking proper mask ventilation. Tracheal intubation to be done with proper sized cuffed Endotracheal tube.
Position of the Surgery to be given and ventilated accordingly.
Maintanance of anaesthesia done with Isoflurane, Intermittent doses Inj.Rocuronium 0.2mg per kg, Inj Fentanyl 1mcg per kg.
Inj Paracetamol 15mg per kg to be given 30 min before extubation.
After closure, local site infiltration with Inj. Bupivacaine (0.25 percentage) to be done at incision sites (2 to 3ml at each site).
Reversal with Inj Neostigmine 0.05 mg per kg with glycopyrolate 0.01mg per kg after noting appropriate Train Of Four response and extubation to be done.
Patients will be Shifted to post-Operative Care unit. Patients will be assessed 2nd hourly on following parameters for 24 hours.
- Visual analogue scale (VAS)
- Rescue analgesia requirement
- Wilson sedation scale
- Patient’s overall satisfaction with Linkert 5 point scale
- Time of earliest mobilization
- Complications (if any)
Post operatively Inj Paracetamol 1 gm IV to be given QID
Inj Diclofenac 75mg IV to be given as rescue analgesia.
Rescue analgesia medication to be given every time VAS more than or equal to 4 and noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients undergoing Total Laparoscopic Hysterectomy during study period.
- •Age group: 40-65 years Female.
- •ASA- I, II, III.
- •Patients providing informed consent.
排除标准
- •Patient refusal.
- •Patients with psychiatric or neurological disorders who cannot give proper pain assessment.
- •Patient already on multiple analgesics due to Diabetic Neuropathic Pain.
- •Patients with kidney diseases or diagnosed diabetic nephropathy.
结局指标
主要结局
Comparision of Pain using VAS in Diabetic and Non-Diabetic patients for 24 hours post Total Laparoscopic Hysterectomy Surgery
时间窗: VAS assessed every 2 hourly for 24 hours post surgery.
次要结局
- Assessment of the effect of Glycosylated Haemoglobin (HbA1c) on Post-opeative Pain.(Comparision of the time of first Rescue Analgesia required within 24 hrs post-operatively in Diabetic vs Non-Diabetic patients.)
研究者
Pandya Niyati Narendrabhai
All India Institute of Medical Sciences, Rajkot..