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A study to evaluate the effectiveness of epidurally given naloxone in reducing nausea and vomiting occurring after surgery, in patients receiving epidural fentanyl for pain relief after lower limb orthopaedic surgeries

A study to evaluate the effectiveness of epidural naloxone in reducing postoperative nausea and vomiting in patients receiving epidural fentanyl for postoperative analgesia following lower limb orthopaedic surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20191126001
Enrollment
Unknown
Registered
2019-11-26
Start date
2017-01-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with lower limb orthopaedic diseases Naloxone Fentanyl PONV Epidural Wong Bakers Scale

Interventions

Patients who received epidurally&#44
only fentanyl with bupivacaine for post operative analgesia,Patients who received epidurally&#44
fentanyl with bupivacaine and naloxone 2 mcg for postoperative analgesia.
Active Comparator Drug,Experimental Drug
Group C,Group N

Sponsors

Azeezia Institute of Medical Sciences & Research, Kollam, Kerala, India
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults between 18-80 years 2. of either sex 3. with ASA physical status 1-3 4. undergoing lower limb orthopaedic surgeries

Exclusion criteria

Exclusion criteria: Patients with 1. allergy to study drugs 2. contraindications to neuraxial anesthesia 3. chronic opioid use 4. significant myocardial, renal, or hepatic impairment 5. psychiatric illness 6. nausea and vomiting during the operation

Design outcomes

Primary

MeasureTime frame
Post Operative Nausea and Vomiting (PONV) 6, 12 and 18 hours post operatively PONV Score—

Secondary

MeasureTime frame
Post Operative Pain 6, 12 and 18 hours post operatively Wong Bakers Pain Scale—

Contacts

Public ContactDR.DERLIN THOMAS

Assistant Professor

derlin.t@gmail.com9447768944

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026