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临床试验/CTRI/2023/05/052229
CTRI/2023/05/052229尚未招募不适用

Comparative study between transdermal buprenorphine patch 5 mcg/hour and 10 mcg/hour in post-operative pain management administered pre-emptively in laparoscopic surgeries under general anaesthesia

ESIC MEDICAL AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Pain-free duration measured using VAS scale

研究概览

简要总结

Postoperative pain management is an essentialcomponent for patient undergoing major surgery. Adequate pain management is achallenge to the anaesthesiologists as there are many adverse effectsassociated with pain physiologically and psychologically which can hamper thenormal recovery process.

The pain signaltransmission evoked by tissue damage leads to sensitization of the peripheraland central pain pathways. This sensitization can be prevented by blocking thepain signal transmission completely from the surgical site.

Pre-emptiveanalgesia is a treatment to reduce this sensitization which is initiated beforesurgery. Due to this protective effect on the nociceptive system, pre-emptiveanalgesia has the potential to be more effective than a similar analgesictreatment initiated after surgery. This helps to reduce immediatepost-operative pain and reduces the total amount of analgesics required the inpost-operative period.

Buprenorphine is a opioid analgesicthat has partial agonistic action at µ receptors and antagonistic action on κ receptor.It is a synthetic thebaine congener. It is a highly lipid-soluble µ analgesicwith great analgesic potency. It is 50 times more potent than morphine but withlower intrinsic activity and has ceiling effect. The onset of action is slowerand duration of action is longer. After a single dose, analgesia lasts for 6–8hours. Transdermal buprenorphine provides a non-invasive methodof drug release at a controlled rate. It ensures constant and predictable serumbuprenorphine levels over a prolonged period. Buprenorphine is homogenouslyincorporated in a solid polymer matrix patch which is applied to the skin. Theadhesive buprenorphine patch is non-invasive, simple and compliant method ofdrug delivery. It slowly and continuously releases the drug into the systemiccirculation. These characteristics suggest that transdermalbuprenorphine may be useful in the postoperative pain management for patientsundergoing laparoscopic surgeries under GA

 The study is conceptualized to comparethe intensity of pain relief of pre-emptively administered transdermal buprenorphinepatch 5 mcg/hr with 10 mcg/hr in post-operative analgesia.

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 55.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I, II Patients posted for laparoscopic surgeries under GA.

排除标准

  • •Patient refusal •Patients with skin allergy •Patients with severe hepatic and renal dysfunction •Pregnant and lactating women •Bleeding disorders •Respiratory diseases such as chronic obstructive pulmonary disease, bronchial asthma •Hypersensitivity to study drug •Epileptic patients •ASA III ,IV.

结局指标

主要结局

Pain-free duration measured using VAS scale

时间窗: From the time of extubation upto 48 hours

次要结局

  • The amount of analgesics required over 48 hrs.(Variation in heart rate, NIBP, MAP intra- operatively.)

研究者

发起方
ESIC MEDICAL AND HOSPITAL
申办方类型
Government medical college

研究点 (1)

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