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

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.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty, Replacement, Knee; Leg Injury
• Intervention / Treatment: Drug: Ropivacaine 0.75% Injectable Solution; Drug: Fentanyl Citrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: ABINASH D JOSHI, MBBS; Phone Number: +9779841866963; Email: abinash.d.joshi@gmail.com
• Study Contact Backup: Name: NAVINDRA R BISTA, MD; Phone Number: 9841461305; Email: navindrarajbista@hotmail.com

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44600
      • Recruiting
      • Tribhuvan University Teaching Hospital
      • Contact: ABINASH D JOSHI, MBBS; Phone Number: +9779841866963; Email: abinash.d.joshi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine With Fentanyl; 2.5ml of 0.75% Isobaric ropivacaine with 0.5ml (25mcg) Fentanyl	Drug: Ropivacaine 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).; Other Names: ROPIN 0.75%; Drug: Fentanyl 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).; Other Names: FENTYL
Active Comparator: Ropivacaine Without Fentanyl; 2.5ml of 0.75% Isobaric Ropivacaine with 0.5ml of Normal Saline	Drug: Ropivacaine 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).; Other Names: ROPIN 0.75%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Uptill 12 hour post surgery

Collaborators and Investigators

• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
• Investigators: Study Chair: ANIL SHRESTHA, MD, Tribhuvan University Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: 0.75% ROPIVACAINE; FENTANYL; SPINAL ANAESTHESIA
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine
• Other Study ID Numbers: 125/(6-11)E2/076/077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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