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

Primary Purpose

Leg Injury, Arthroplasty, Replacement, Knee

Status
Unknown status
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
Ropivacaine 0.75% Injectable Solution
Fentanyl Citrate
Sponsored by
Tribhuvan University Teaching Hospital, Institute Of Medicine.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Injury focused on measuring 0.75% ROPIVACAINE, FENTANYL, SPINAL ANAESTHESIA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients planned for lower limb surgeries under spinal anaesthesia.

Exclusion Criteria:

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

Sites / Locations

  • Tribhuvan University Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ropivacaine With Fentanyl

Ropivacaine Without Fentanyl

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 6, 2019
Last Updated
January 9, 2020
Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
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1. Study Identification

Unique Protocol Identification Number
NCT04199013
Brief Title
Comparison of Ropivacaine With or Without Fentanyl in Spinal Anaesthesia for Lower Limb Surgeries
Official Title
Comparison of Ropivacaine With or Without Fentanyl in Spinal Anaesthesia for Lower Limb Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Injury, Arthroplasty, Replacement, Knee
Keywords
0.75% ROPIVACAINE, FENTANYL, SPINAL ANAESTHESIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine With Fentanyl
Arm Type
Active Comparator
Arm Description
2.5ml of 0.75% Isobaric ropivacaine with 0.5ml (25mcg) Fentanyl
Arm Title
Ropivacaine Without Fentanyl
Arm Type
Active Comparator
Arm Description
2.5ml of 0.75% Isobaric Ropivacaine with 0.5ml of Normal Saline
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.75% Injectable Solution
Other Intervention Name(s)
ROPIN 0.75%
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate
Other Intervention Name(s)
FENTYL
Intervention Description
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).
Primary Outcome Measure Information:
Title
Time for block regression to S2 segment
Description
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 Outcome Measure Information:
Title
Total duration of analgesia
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients planned for lower limb surgeries under spinal anaesthesia. Exclusion Criteria: Patient refusal. Patient height less than 150 cm. History of hypersensitivity to study drugs. Pregnancy. Patient unable to communicate verbally.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABINASH D JOSHI, MBBS
Phone
+9779841866963
Email
abinash.d.joshi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
NAVINDRA R BISTA, MD
Phone
9841461305
Email
navindrarajbista@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANIL SHRESTHA, MD
Organizational Affiliation
TRIBHUVAN UNIVERSITY TEACHING HOSPITAL
Official's Role
Study Chair
Facility Information:
Facility Name
Tribhuvan University Teaching Hospital
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
44600
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ABINASH D JOSHI, MBBS
Phone
+9779841866963
Email
abinash.d.joshi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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