A clinical trial to study the pain relieving effect of two different doses of buprenorphine patch in post-operative pain relief in patients undergoing laparoscopic surgeries under general anaesthesia
- Conditions
- Obstetrics, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: K35-K38||Diseases of appendix, (5) ICD-10 Condition: K40-K46||Hernia, (6) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (7) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,
- Registration Number
- CTRI/2023/05/052229
- Lead Sponsor
- ESIC MEDICAL AND HOSPITAL
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 90
ASA physical status I, II Patients posted for laparoscopic surgeries under GA.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain-free duration measured using VAS scale From the time of extubation upto 48 hours
- Secondary Outcome Measures
Name Time Method The amount of analgesics required over 48 hrs. Variation in heart rate, NIBP, MAP intra- operatively.
Trial Locations
- Locations (1)
ESIC MEDICAL COLLEGE AND HOSPITAL
🇮🇳Chennai, TAMIL NADU, India
ESIC MEDICAL COLLEGE AND HOSPITAL🇮🇳Chennai, TAMIL NADU, IndiaPROF DR ILANGO GANESANPrincipal investigator9884149429gilang@rediffmail.com