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Status unknownNCT04199013Updated Jan 13, 2020

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

A Phase 4 interventional study of Ropivacaine 0.75% Injectable Solution and Fentanyl Citrate in Leg Injury and Arthroplasty, Replacement, Knee, sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine.. Status unknown at 1 site in Nepal. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Spinal anaesthesia has been a widely used mode of anaesthesia for lower abdominal and extremity surgeries. It blunts the "stress response" to surgery, decreases intraoperative blood loss, lowers the incidence of postoperative thromboembolic events, and decreases the morbidity in high-risk surgical patients. It serves as a useful method to extend analgesia into the postoperative period, where its use has been shown to provide better analgesia than parenteral opioids. In order to improve further and understand safety issues as well as the clinical use of spinal anesthesia, new local anesthetics and analgesic additives are being investigated for different application. With patient safety and comfort being the ultimate goal of any health practice, one must keep in mind about the side effects and related concerns of spinal anesthesia while achieving the desired level of anaesthesia and analgesia. Adequate anesthesia and analgesia during and post-surgery along with early ambulation and discharge seems to be the perfect recipe for the conduction of spinal anaesthesia in the current practice. Ropivacaine is one local anesthetic that could have the potential in this area. Ropivacaine is an amide local anesthetic with properties similar to bupivacaine producing similar sensory block at equipotent doses, but with a shorter duration of motor block. Thus, ropivacaine has a greater degree of motor sensory differentiation, which could be useful when motor blockade is undesirable. Ropivacaine blocks nerve fibers involved in pain transmission (A∂and C fibers) to a greater degree than those controlling motor function (Aβ fibers).Blockade of Aα and Aβ is slow and hence produces lesser motor blockade than bupivacaine. Though 40-50% less potent than bupivacaine, ropivacaine in an equipotent ratio of 1.5:1 produces results in a similar clinical profile with good preservation of motor function. Hence, its shorter duration, faster recovery of motor function, lower toxicity profile, and minimal hemodynamic alterations have been identified as a potential benefit for surgery of intermediate duration as well as for ambulatory surgery.

Though the use of bupivacaine is widespread, ropivacaine in the recent times has been used as a spinal anaesthetic agent and evaluated in many procedures because of its equivalent spinal anaesthetic effect and its lower risk of neurotoxicity and cardiotoxicity, compared with bupivacaine. In addition, there have been reports of fatal cardiovascular toxicity following use of bupivacaine in regional anesthesia.

Subarachnoid opioids with local anesthetics have become a well-accepted practice in spinal anesthesia for surgical procedures. Several combinations of local anesthetics such as lidocaine, bupivacaine, or ropivacaine, and opioids such as fentanyl have been reported for a variety of surgical procedures. The addition of small-dose fentanyl (10-25 μg) intrathecally to local anesthetics during spinal anesthesia has been shown to enhance duration of sensory analgesia.The addition of adjuvants to ropivacaine has shown to improve the quality of intra-operative and postoperative analgesia without compromising its benefits such as early mobilization and early voiding. Parlow et al. established the fact that hypobaricity influenced the extent of subarachnoid block and explained high cephalic levels of sensory block when fentanyl was added to isobaric local anesthetic solution.

02

Conditions studied

  • Leg Injury
  • Arthroplasty, Replacement, Knee

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Keywords

  • 0.75% ROPIVACAINE
  • FENTANYL
  • SPINAL ANAESTHESIA
03

In context

Leg Injuries

58 studies on the registry are indexed under Leg Injuries; 14 are open to participants now.

This study's planned enrollment of 74 is above the median of 50 across 40 interventional studies indexed under Leg Injuries.

Browse Leg Injuries studies →

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine. is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients planned for lower limb surgeries under spinal anaesthesia.

Exclusion criteria

Exclusion Criteria:

  • Patient refusal. Patient height less than 150 cm. History of hypersensitivity to study drugs. Pregnancy. Patient unable to communicate verbally.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
74 participants (estimated)

Study arms

  • Active comparator
    Ropivacaine With Fentanyl

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

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

  • Active comparator
    Ropivacaine Without Fentanyl

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

    Drug: Ropivacaine 0.75% Injectable Solution

Interventions

  • DrugRopivacaine 0.75% Injectable Solution

    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%

  • DrugFentanyl Citrate

    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

06

What researchers measure

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.

    Time frame: Up till 5 hours from spinal block

Secondary outcomes

  1. Total duration of analgesia

    Duration of analgesia will be defined as time interval from subarachnoid injection to the point where patients demanded rescue analgesics for pain relief. Analgesia for pain management will be given as per the hospital protocol.

    Time frame: Uptill 12 hour post surgery

07

Study locations

1 of 1 sites recruiting
  • Tribhuvan University Teaching Hospital
    Kathmandu, Bagmati 44600, Nepal
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04199013
Lead sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Responsible party
ABINASH DHOJ JOSHI (RESIDENT DOCTOR, Tribhuvan University Teaching Hospital, Institute Of Medicine.) — Principal investigator
First posted
Dec 13, 2019
Start date
Jan 10, 2020
Primary completion
Mar 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 13, 2020

Study contacts

ABINASH D JOSHI, MBBS
Contact
abinash.d.joshi@gmail.com
+9779841866963
NAVINDRA R BISTA, MD
Contact
navindrarajbista@hotmail.com
9841461305
ANIL SHRESTHA, MD
study chair · TRIBHUVAN UNIVERSITY TEACHING HOSPITAL

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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