THE EFFICACY AND SAFTEY OF AN INJECTION NAMED NEFOPAM HYDROCHLORIDE FOR PAIN RELIEF AFTER UNDERGOING LOWERLIMB SURGERIES UNDER SPINAL ANAESTHESIA.

Not yet recruiting

• Conditions: External causes of morbidity,

• Registration Number: CTRI/2021/11/037887
• Lead Sponsor: JSS MEDICAL COLLEGE AND HOSPITAL

Brief Summary

-  Following approval from institutional ethical committee, informed consent will be taken from 96 geriatric participants of American SocietyofAnaesthesiologists (ASA) Physical status 1 and 2 undergoing elective lower limb surgeries under spinal Anesthesia.

A thorough pre anaesthetic evaluation will be done 24 hours prior to the procedure.

Patients will be premeditated with Tab.Pantoprazole 40mg and Tab. Alprazolam 0.5 mg. On the morning of study, all patients will have an IV access secured before spinal anaesthesia.After connecting multi parameter monitors with ECG,pulse oximetry and non invasive blood pressure ( NIBP ), basal parameters will be recorded.Spinal anaesthesia with 25G Quinckes spinal needle using Inj.Bupivacaine 2.5 ml (0.5%) H andInj fentanyl 25 mcg will be given in sitting posture and then patient is changed to supine posture. Hemodynamic parameters - PR, BP, SPO2 will be monitored at 15 minute intervals till the end of the surgery.



After the patient is shifted to postoperative ward, NRS scores are assessed. If NRS> 4 is recorded, Inj Nefopam 20 mg in 100ml saline will be started over 30 mins. Following which PR, BP, SPO2 , RR will be monitored at 0,10,20,30 minute intervals and any adverse events will be noted. The next doses of nefopam will be given once a NRS score of 4 is recorded thereafter till 24 hours.



In spite of giving nefopam, if patients complains of pain within 24 hours of administering the drug Inj. Tramadol 50mg IV will be given at NRS more than or equal to 4. At the end of 24 hours,the total rescue analgesic requirement will be calculated.



Every time after the drug is given , degree of pain relief and duration of analgesia of nefopam hydrochloride postoperatively will be recorded along with the variations in hemodynamic parameters and adverse effects in elderly people.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-08-11
• Study Start: 2021-11-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Asa 1/2 Undergoing lower limb orthopaedic surgeries under spinal anaesthesia.

Exclusion Criteria

Patients undergoing emergency surgeries, patients with renal and hepatic insufficiency , patients with convulsive disorders and on MAO-inhibitor drugs , patients having it’d and those with cognitive dysfunction.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate degree of pain relief and to determine duration of analgesia of Nefopam hydrochloride.	Postoperatively when NRS score is 4 and 4th hourly till 24 hours.

Secondary Outcome Measures

Name	Time	Method
To assess the rescue analgesic requirement , variations in hemodynamic parameters and to study adverse effects of nefopam in elderly people.	Postoperatively when NRS score is 4 and 4th hourly till 24 hours.

Trial Locations

Locations (1)

JSS MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Mysore, KARNATAKA, India

JSS MEDICAL COLLEGE AND HOSPITAL

🇮🇳Mysore, KARNATAKA, India

Dr Chandu Korla

Principal investigator

9966885244

chandukorla193@gmail.com