Comparison of Ropivacaine With or Without Fentanyl in Spinal Anaesthesia for Lower Limb Surgeries

NCT04199013 | Unknown Phase 4 DMC

• 1 other identifier: 125/(6-11)E2/076/077
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

There has been a wide variety of use of anaesthetic agents along with adjuncts during subarachnoid block. The quest for attaining adequate analgesia and anaesthesia has always been shadowed by the concurrent deleterious effect of the anaesthetic agent. Ropivacaine as an anesthetic agent has proven to meet the desired goals of anaesthesia while minimizing the potential side effects. The addition of different adjuncts has shown to enhance the analgesic property, prolong the duration of sensory blockade and decrease the dose related adverse effects of the local anaesthetics. Fentanyl in this regards has also shown some promising effects. Thus we compare the use of ropivcaine as a single agent versus ropivacaine along with an adjunct (Fentanyl) to attain the desired anesthetic effect while minimizing the associated side effects.

Conditions

Leg Injury; Arthroplasty, Replacement, Knee

Keywords

0.75% ROPIVACAINE; FENTANYL; SPINAL ANAESTHESIA

Outcome Measures

Primary Outcomes (1)

• Time for block regression to S2 segment

  The total duration of sensory blockade will be defined as the time interval between spinal anesthesia till block regression to S2 segment. Time for block regression to S2 segment will be noted every 30 mins after end of surgery.

  Up till 5 hours from spinal block

Secondary Outcomes (1)

• Total duration of analgesia

  Uptill 12 hour post surgery

Study Arms (2)

Ropivacaine With Fentanyl

ACTIVE COMPARATOR

2.5ml of 0.75% Isobaric ropivacaine with 0.5ml (25mcg) Fentanyl

Drug: Ropivacaine 0.75% Injectable Solution; Drug: Fentanyl Citrate

Ropivacaine Without Fentanyl

ACTIVE COMPARATOR

2.5ml of 0.75% Isobaric Ropivacaine with 0.5ml of Normal Saline

Drug: Ropivacaine 0.75% Injectable Solution

Interventions

Ropivacaine 0.75% Injectable Solution DRUG

Patients in Group R will receive subarachnoid injection of 2.5 ml of 0.75% isobaric ropivacaine (18.75 mg) and 0.5 ml normal saline while patients in Group RF will receive subarachnoid injection of 2.5 ml 0.75% of isobaric ropivacaine (18.75 mg) and 0.5 ml fentanyl (25 μg).

Also known as: ROPIN 0.75%

Ropivacaine With Fentanyl; Ropivacaine Without Fentanyl

Fentanyl Citrate DRUG

Patients in Group R will receive subarachnoid injection of 2.5 ml of 0.75% isobaric ropivacaine (18.75 mg) and 0.5 ml normal saline while patients in Group RF will receive subarachnoid injection of 2.5 ml 0.75% of isobaric ropivacaine (18.75 mg) and 0.5 ml fentanyl (25 μg).

Also known as: FENTYL

Ropivacaine With Fentanyl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for lower limb surgeries under spinal anaesthesia.

You may not qualify if:

• Patient refusal. Patient height less than 150 cm. History of hypersensitivity to study drugs. Pregnancy. Patient unable to communicate verbally.

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

RECRUITING

MeSH Terms

Conditions

Leg Injuries

Interventions

Ropivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ANIL SHRESTHA, MD

  TRIBHUVAN UNIVERSITY TEACHING HOSPITAL

  STUDY CHAIR

Central Study Contacts

ABINASH D JOSHI, MBBS

CONTACT

+9779841866963; abinash.d.joshi@gmail.com

NAVINDRA R BISTA, MD

CONTACT

9841461305; navindrarajbista@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT DOCTOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 13, 2019
• Study Start: January 10, 2020
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)