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

Not yet recruiting

• Conditions: Age between 18 to 60 years, ASA I and II, both male and female patients undergoing lower limb surgery.

• Registration Number: CTRI/2017/05/008588

Brief Summary

Intrathecal opoids are synergistic with local anaesthtics and intensify the sensory block without increasing the sympathetic block. They are commonly added to local anaesthetic for potentiating their effects, reducing their doses, and thereby reducing their complication and side effect. They also prolong the duration of post operative analgesia. Few studies investigated intrathecal nalbuphine with hyberbaric bupivacaine , and as for as we know, no study had been done using isobaric ropivacaine as local anaesthetic and intrathecal nelbuphine are added as adjuant  and compared for it postoperative analgesic effects with fentanyl.

The study is a randomized, double blind, parallel group trial comparing effeicacy and safety of intrathecal nalbuphine 500mcg and Fentanyl 25mcg with newer local anaesthetics isobaric Ropivacaine. The patient will be divided randomly using computer generated number  into two equal groups (n=50) : Group RN will receive 0.75% ropivacaine (2.5ml) and 0.5ml nalbuphine (500mcg), Group RF will receive 0.75% of ropivacaine (2.5ml) 0.5ml fentanyl (25mcg). All patients are clinically assessed and routein preop. investigation will be done before procedure.  Baseline parameter will be noted on arrival to OT room or preop room. All patient will be pre-loaded with Ringer solution 10ml/kg  before procedure. Under all aseptic and antiseptic precaution dural puncture was performed in sitting position in L3-L4 interspce with a 25 G Quinke spinal needle. Intraoperatively HR, NIBP, RR, SpO2 were recorded  at 5 minute interval. Primary outcome measures will be duration of analgesia and Block characteristics ( onset and duration of sensory and motor block). The secondary outcome will be changes in hemodynamics and adverse side effects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-05-16
• Study Start: 2017-06-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of Analgesia and block characteristics	12 hr.

Secondary Outcome Measures

Name	Time	Method
Hemodynamics and adverse event	12 hr.

Trial Locations

Locations (1)

Banaras Hindu University; 🇮🇳 Varanasi, UTTAR PRADESH, India

Banaras Hindu University

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Yashpal Singh

Principal investigator

919918424416

dryashacin1999@rediffmail.com