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Leg InjuryPhase 4NCT04199013

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

A Phase 4 study testing Ropivacaine 0.75% Injectable Solution and Fentanyl Citrate in people with Leg Injury and Arthroplasty, Replacement, Knee, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Leg Injury, Arthroplasty, Replacement, Knee
What is being tested?
Ropivacaine 0.75% Injectable Solution and Fentanyl Citrate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteNepal
Study dates
10 Jan 2020to Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients planned for lower limb surgeries under spinal anaesthesia.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

ABINASH D JOSHI, MBBS contact

+9779841866963

abinash.d.joshi@gmail.com

NAVINDRA R BISTA, MD contact

9841461305

navindrarajbista@hotmail.com

Nepal1 site, 1 recruiting
  • Tribhuvan University Teaching Hospital

    Kathmandu, Bagmati, 44600

    ABINASH D JOSHI, MBBS, +9779841866963, abinash.d.joshi@gmail.com

    Recruiting

Other trials in Nepal

About this study

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.

Being tested
Ropivacaine 0.75% Injectable Solution, Fentanyl Citrate
Keywords
0.75% ROPIVACAINE, FENTANYL, SPINAL ANAESTHESIA
Medical subject headings
Leg Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine 0.75% Injectable SolutionDrug

    Also called ROPIN 0.75%

    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).

  • Fentanyl CitrateDrug

    Also called FENTYL

    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).

Study groups in NCT04199013
Study groupRoleWhat they receive
Ropivacaine With FentanylActive comparator2.5ml of 0.75% Isobaric ropivacaine with 0.5ml (25mcg) Fentanyl
Receives: Drug: Ropivacaine 0.75% Injectable Solution; Drug: Fentanyl Citrate
Ropivacaine Without FentanylActive comparator2.5ml of 0.75% Isobaric Ropivacaine with 0.5ml of Normal Saline
Receives: Drug: Ropivacaine 0.75% Injectable Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up till 5 hours from spinal block

Secondary outcomes (1)
  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.

    Measured: Uptill 12 hour post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start10 Jan 2020
  3. Primary completionMar 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04199013
Sponsor's protocol ID
125/(6-11)E2/076/077
Status last verified
Jan 2020
First submitted
6 Dec 2019
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine 0.75% Injectable Solution and Fentanyl Citrate in people with Leg Injury and Arthroplasty, Replacement, Knee, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ABINASH D JOSHI, MBBS (+9779841866963, abinash.d.joshi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time for block regression to S2 segment (time frame: Up till 5 hours from spinal block). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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