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临床试验/NCT02866409
NCT02866409已完成2 期

Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Post Craniotomy Pain

NAVNEH SAMAGH0 个研究点目标入组 150 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
150
主要终点
post craniotomy pain by Numerical rating scale (NRS)

研究概览

简要总结

This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control post craniotomy pain.A third group where patients were administered bupivacaine only infiltration has also been created.

详细描述

Patients were randomly allocated into three equal groups by computer generated random numbers. For randomization, the simple random allocation rule was followed, wherein the total sample size (n = 150) was randomly divided into three equal groups. In the event of any case has to be excluded because of requirement of postoperative ventilation, altered sensorium or high grade fever in the post-operative period, the same random number code was allocated to the next patient in order to ensure an equal sample size without any modification to the original random number table. The random numbers were then kept in opaque sealed envelopes, numbered sequentially which were opened just before shifting patient inside operation theatre.

The anaesthesiologist who prepared and administered the study drug were not involved in collection of data. The anaesthesiologist who collected the data from the patient in the postoperative period, the operating surgeon and the patient were blinded to the group assigned to the patient.

Pre-operative Assessment:

Pre-operative anaesthetic evaluation was done on the day prior to the surgery. This included a detailed history regarding physical health, any co-morbid illness, current medications, drug allergy and previous anaesthetic experience. The patient was made familiar about the NRS (0-10, with 0 = no pain, 10 = worst pain ever). A written and informed consent was taken. Patients were fasted and premedicated according to the departmental protocol.

Duration of study period-

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Neurosurgical patients
  • 18-70 years of age
  • ASA class I and II
  • Patients undergoing elective craniotomy, who were conscious and oriented to time, person and place and able to understand and use Numerical Rating Scale (NRS)

排除标准

  • Patient dull and irritable
  • Craniotomy incision extending beyond scalp (the field of the block) e.g. craniofacial surgery
  • Patients treated chronically with analgesics or narcotic medications
  • Allergy to local anaesthetics or dexmedetomedine
  • Patients planned for post-operative mechanical ventilation
  • Following patients were excluded from the study during collection of data in the postoperative period:-
  • Patients developing fever (≥39°C) in the postoperative period
  • Requiring postoperative ventilation (unplanned)
  • Having poor cognitive function at 1 hour postoperative period
  • GCS <15 in post-operative period.

研究组 & 干预措施

Bupivacaine,dexmedetomidine scalp block

Experimental

Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept < 2 mg /kg for scalp block

干预措施: scalp block (Procedure)

Bupivacaine,dexmedetomidine scalp block

Experimental

Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept < 2 mg /kg for scalp block

干预措施: Dexmedetomidine (Drug)

Bupivacaine,dexmedetomidine scalp block

Experimental

Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept < 2 mg /kg for scalp block

干预措施: Bupivacaine (Drug)

bupivacaine dexmedetomidine infiltration

Active Comparator

The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

干预措施: infiltration (Procedure)

bupivacaine dexmedetomidine infiltration

Active Comparator

The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

干预措施: Dexmedetomidine (Drug)

bupivacaine dexmedetomidine infiltration

Active Comparator

The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

干预措施: Bupivacaine (Drug)

bupivacaine infiltration

Active Comparator

The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

干预措施: infiltration (Procedure)

bupivacaine infiltration

Active Comparator

The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

post craniotomy pain by Numerical rating scale (NRS)

时间窗: 48 hours post extubation

次要结局

  • chronic pain using Numerical rating scale (NRS)(3 months)
  • post operative sedation using Modified Ramsay Sedation Scale(48 hours.)
  • rescue analgesic requirement in grams(48 hrs)

研究者

发起方
NAVNEH SAMAGH
申办方类型
Unknown
责任方
Sponsor Investigator
主要研究者

NAVNEH SAMAGH

senior resident

Post Graduate Institute of Medical Education and Research, Chandigarh

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