A comparative study of post-operative analgesic efficacy of 0.25 percentage ropivacaine with dexmedetomidine versus dexamethasone as an adjuvant in bilateral superficial cervical plexus block for midline neck surgery under general anaesthesia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To check post operative reduction in opioids requirement with drug
研究概览
简要总结
A comparative study of post-operative analgesic efficacy of 0.25 percentage ropivacaine with dexmedetomidine versus dexamethasone as an adjuvant in bilateral superficial cervical plexus block for midline neck surgery under general anaesthesia.
A study to compare post-operative effect of skin infiltration of dexmedetomidine with ropivacaine versus dexamethasone with ropivacaine in midline neck surgery under general anaesthesia.
OBJECTIVES
· To evaluate the duration of postoperative analgesia and requirement of analgesic doses during 24hours.
· To assess Ramsay sedation score.
· To assess intraoperative and postoperative haemodynamics.
· To find out duration of rescue analgesia.
· To detect Side effects/complication, if any.s
Inclusion Criteria:
· Patients willing to participate in the studys.
· Patients of ASA Grade I and II of either gender.
· Patients undergoing elective midline neck surgeries under general anaesthesia
· Age of patients 18-65 years.
Exclusion Criteria:
· Patient refusal.
· Patient not nil by mouth.
· Patients with uncontrolled systemic disease like heart disease, liver disease, kidney disease.
· Patients with anaemia, shock, septicaemia, uncontrolled hypertension.
· Patients with bleeding and coagulation disorders
· Infection at site · History of upper mediastinal irradication
· Inability to tolerate general anaesthesia
· Any neck metastasis
· History of previous head and neck surgery
· Hoarse and weak voice
Methods:
This randomized clinical study will be conducted in Department of Anaesthesiology in Dhiraj hospital. After approval from institutional ethical committee a study will be conducted on 50 patients including both genders, aged between 18 to 65 years which will be equally divided randomly in 2 groups by chit method {Group A (0.25% Ropivacaine + Dexmedetomidine), Group B (0.25% ropivacaine + Dexamethasone)} for bilateral superficial cervical plexus block undergoing elective midline neck surgery under general anaesthesia will be selected. The drug will be administered by the anaesthesiologist not related to study. Group A (n=25) will receive 0.25% Ropivacaine 19ml + 50 mcg Dexmedetomidine 1 ml and Group B (n=25) will receive 0.25% Ropivacaine 19 ml + 4 mg Dexamethasone 1ml. All the patients will be explained clearly about the purpose and nature of the study in the language they can understand. They will be included in the study only after obtaining a written informed consent.
Study site: DHIRAJ HOSPITAL, S.B.K.S. MEDICAL INSTITUTE AND RESEARCH CENTER, SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY, PIPARIA, VADODARA, GUJARAT.
Study design: randomized clinical study
LIKELY OUTCOME / BENEFITS OF THE STUDY:
This study will help us to know which drug out of two will be provide post operative analgesia more effectively and reduces the post operative intravenous analgesic use within 24 hours after midline neck surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients willing to participate in the studys.
- •Patients of ASA Grade I and II of either gender.
- •Patients undergoing elective midline neck surgeries under general anaesthesia
- •Age of patients 18-65 years.
排除标准
- •1 Patient refusal.
- •2 Patient not nil by mouth.
- •3 Patients with uncontrolled systemic disease like heart disease, liver disease, kidney disease.
- •4 Patients with anaemia, shock, septicaemia, uncontrolled hypertension.
- •5 Patients with bleeding and coagulation disorders 6 Infection at site 7 History of upper mediastinal irradication 8 Inability to tolerate general anaesthesia 9 Any neck metastasis 10 History of previous head and neck surgery 11 Hoarse and weak voice.
结局指标
主要结局
To check post operative reduction in opioids requirement with drug
时间窗: Pain assessment every 2hrly post operatively from 0hr to 24hr.
0.25% ropivacaine with dexmedetomidine versus dexamethasone as an
时间窗: Pain assessment every 2hrly post operatively from 0hr to 24hr.
adjuvant given in bilateral superficial cervical plexus block for midline neck
时间窗: Pain assessment every 2hrly post operatively from 0hr to 24hr.
surgery under general anaesthesia.
时间窗: Pain assessment every 2hrly post operatively from 0hr to 24hr.
次要结局
- Sedation score & any side effects.(Post-operatively after extubation & then at 2 hourly till 24 hours.)
研究者
Devendra Joshi
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre
