Duration of Pain relief using two different intrathecal opoids (Nalbuphine vs. Fentanyl) in lower limb surgeries.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/05/008588
• Date of registration: 17-05-2017
• Prospective Registration: Yes
• Primary sponsor: None
• Public title: Duration of Pain relief using two different intrathecal opoids (Nalbuphine vs. Fentanyl) in lower limb surgeries.
• Scientific title: Comparative Study Between Intrathecal Nalbuphine and Fentanyl as adjuvant with Ropivacaine in lower limb surgeries: A Prospective, Randomized,Double Blind Study
• Date of first enrolment: 19-06-2017
• Target sample size: 100
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12826
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Yashpal Singh
• Affiliation: Institute of Medical Sciences, Banaras Hindu University, Varanasi

• Name: Dr Yashpal Singh
• Affiliation: Institute of Medical Sciences, Banaras Hindu University, Varanasi

Key inclusion & exclusion criteria

Inclusion criteria: Patients aged between 18 to 60 yrs with ASA I & II, of either sex, undergoing lower limb surgeries.
Exclusion criteria: -Pre-existing neurological deficit/peripheral neuropathy

-Coagulation disorders

-Local infection at the site of block.

-Pregnancy

-History of allergy to amide local anesthetics

-Patient refusal to participate in the study

-Patient having cardio or respiratory system failure

-Uncooperative patients.

-Patient with h/o end organ damage



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Age between 18 to 60 years, ASA I and II, both male and female patients undergoing lower limb surgery.

Intervention(s)

Intervention1: Inj. Nelbuphine 500mcg: Inj. Nelbuphine hydro chloride 500mcg (Inj.Ruffy 10mg/ml, Dr. Reddy Laoratories Ltd.), given intrthecally along with ropivacaine.
Control Intervention1: Inj. Fentanyl 25mcg: Inj. Fentanyl 25mcg (Trofentyl 50mcg/ml,from Troikaa Pharmaceuticals ) given intrathecally along with Ropivacaine.

Primary Outcome(s)

Duration of Analgesia and block characteristicsTimepoint: 12 hr.

Secondary Outcome(s)

Hemodynamics and adverse eventTimepoint: 12 hr.

Secondary ID(s)

NIL

Source(s) of Monetary Support

No Funding Organization

Ethics review

Status: Approved
Approval date: 02/09/2015
Contact:

Institunal ethical commette, Faculty of Medicine, IMS, BHU