FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074603 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 29/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparing the effect of the drugs Levobupivacaine with Fentanyl versus Levobupivacaine with Demedetomidine in patients undergoing caesarean section under spinal anaesthesia 
Scientific Title of Study   Efficacy of intrathecal Levobupivacaine with Fentanyl vs Levobupivacaine with Dexmedetomidine in patients undergoing LSCS: A prospective hospital based study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Addhavan R S 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9342318177  
Fax    
Email  adhavanram16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kedareshvara K S 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886375154  
Fax    
Email  kedareshvara@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Addhavan R S 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9342318177  
Fax    
Email  adhavanram16@gmail.com  
 
Source of Monetary or Material Support  
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka. India. Pincode-590010 
 
Primary Sponsor  
Name  Addhavan R S 
Address  Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi, Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Addhavan R S  KLES Dr Prabhakar Kore Hospital and Medical Research Centre  Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA 
9342318177

adhavanram16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi-590010   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine with fentanyl  Patient receiving intrathecal hyperbaric levobupivacaine of 2.1 ml plus 25mcg(0.5ml) of fentanyl a total of 2.6ml 
Comparator Agent  Levobupivacine with dexmedetomidine  Patient receiving intrathecal hyperbaric levobupivacine of 2.1 ml plus 5 mcg(0.05ml) of dexmedetomidine plus 0.45ml of distilled water a total of 2.6ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  ASA grade 1 and 2
Age between 18 to 40 years
Height 150 TO 175 cms
Weight 45 TO 80 kg 
 
ExclusionCriteria 
Details  Coagulation disorders
Foetal distress
Patients with gestational hypertension
Patient refusal 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the onset, duration of sensory and motor block and requirement of rescue analgesia for patients undergoing caesarean section under spinal anaesthesia with intrathecal fentanyl or dexmedetomidine with levobupivacine(H)  0 min, 1 min, 2 mins and after 4 to 6 hrs  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the haemodynamic parameters such as heart rate, non-invasive blood pressure, SpO2 between both the drugs  Baseline (0 mins), 1 mins, 3 mins, 5 mins, 10 mins, 15 mins,20 mins,25 mins,30 mins,35 mins,40 mins,45 mins,50 mins,55 mins,60 mins 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   11/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Spinal anaesthesia is the most commonly performed anaesthetic technique for caesarean section .At first lidocaine 5% was used as local anaesthetic for lscs procedure, it usage has decreased because it caused transient neurologic symptoms. After that Bupivacine 0.5% hyperbaric was used and it also has increased the duration of motor block. So Intrathecal local anesthetics alone are not enough for effective postoperative analgesia and higher doses of local anaesthetics are also associated with hemodynamic instability, which can lead to unfavorable maternal and fetal outcome. So far many adjuncts have been used to prolong the analgesia produced by intrathecal LA and to reduce their adverse effects. They are fentanyl, ketamine, dexmedetomidine, clonidine, buprenorphine midazolam and etc.

After that a new drug a levobupivacine plain was used as a local anaesthetic for caesarean section and other lower limb surgeries as it has better sensory blockade and faster regression of motor blockade compared to bupivacaine.The very latest addition to local anaesthetic used for lscs is hyperbaric levobupivacaine, which is the s enantiomer of bupivacaine and was introduced recently. Levobupivacaine seems identical to bupivacaine in potency and shows longer duration of action on neural tissue.Hyperbaric levobupivacaine has less cardiotoxicity propensity and less chance of cephalic spread, which favor particularly in LSCS. In the postoperative period prolonging the analgesia is the best way to encourage for early ambulation of patients.

Fentanyl is a lipophilic μ-receptor agonist opioid. Intrathecally, fentanyl exerts its effect by combining with opioid receptors in the dorsal horn of spinal cord and may have a supra spinal spread and action . It has been well documented that a combination of fentanyl with local anaesthetic has prolonged the sensory blockade without intensifying motor blockade.

Dexmedetomidine is a highly selective α2–adrenoceptor agonist, and recently used as an adjuvant with intrathecal local anaesthetic and found to prolong the duration of sensory and motor blockade as well as to provide hemodynamic stability during intraoperative period. It also produces dose dependent sedation, anxiolysis and analgesia (involving spinal and supraspinal sites) without respiratory depression.

Dexmedetomidine is a potent alpha 2 adregenic agonist with a half life of 2 to 3 hrs and it undergoes hepatic metabolism and excreted by kidneys. It has dose dependent action. Adverse effects are hypotension and bradycardia. Fentanyl is metabolized by N-demethylation and excreted by kidneys. Its half life is 3 to 6 hrs. Adverse are effects respiratory suppression, bradycardia , hypotension, pruritis and it should be avoided in head injury patients.

Till now studies have been conducted by using isobaric levobupivacine. But now recently hyperbaric levobupivacine is available and we are conducting a study by using hyperbaric levobupivacine.


The primary objective of the study is to compare the onset and duration of motor and sensory block and requirement of rescue analgesia for patients undergoing caesarean section under spinal anaesthesia with intrathecal fentanyl or dexmedetomiine with levobupivacaine(H)

The secondary objective of the study is to compare the haemodynamic parameters such as heart rate, non-invasive blood pressure, SpO2 between both the drugs.

Patient fullfilling the eligibility criteria will be assigned to one of two groups.

GROUP F : Patient receiving hyperbaric levobupivacine of 2.1 ml plus 0.5ml of 25mcg of fentanyl so total volume of 2.6ml .

       GROUP D : Patient receiving hyperbaric levobupivacine of 2.1 ml plus 0.05ml 5mcg of dexmedetomidine plus 0.45ml of distilled water so total volume of 2.6ml  

Assigning of patients into two groups was performed by anesthesiologist involved in drug preparations. Other investigator involved in the procedure and monitoring was unaware of group allocation. Patients were also blinded to the drug regimen used in spinal anesthesia. On arrival to operating room, baseline parameters recorded. Peripheral 18G cannula secured and preloading done with lactated ringer solution 10 ml/kg. Before spinal anesthesia patients were explained about the procedure and methodology of monitoring methods. In sitting position under strict aseptic precautions, using a midline approach lumbar puncture was performed at L3-L4 intervertebral space by 25G Quincke spinal needle. After confirming the free flow of cerebrospinal fluid, the studied drug solution was injected intrathecally and patients were made into supine position. Primary outcome is to determine time taken to achieve motor block and sensory block that is the duration of time taken from time of giving spinal to the onset of action of drug to produce motor and sensory block ,Duration of motor block and sensory block is that time taken from the onset of block to time when the spinal wares off and Duration of analgesia is that when the patient feels the pain and next dose of analgesic is started.Secondary outcome was to compare the hemodynamic parameters such as heart rate , blood pressure and spo2. The level of sensory block assessed, by pinprick test or cold test and dermatomes levels were tested until the highest level had stabilized by consecutive tests. The motor dermatome level was assessed using Modified Bromage scale. Bromage 0 – full flexion of knees and feet, Bromage 1 – just able to move knees, Bromage 2 – able to move feet only, Bromage 3 – unable to move feet and knees[14]. The time to reach Bromage scale 3 before surgery and Bromage 0 in post anesthesia care unit (PACU) was recorded. On achieving sensory and motor blockade and Bromage scale 3 surgery was allowed. Pain was assessed using Visual Analog Score VAS (0 to 10) scale at time of incision and at completion of surgery. VAS 0 – No pain , VAS 1 to 2 – least pain , VAS 3 to 4 – mild pain , VAS 5 to 6 – moderate pain , VAS 7 to 8 – severe pain , VAS 9 to 10 -  excruciating pain. After surgery patient shifted to PACU and observed for hemodynamic parameters, duration of sensory block, duration of motor block, degree of postoperative analgesia and need of rescue analgesic. Hypotension, defined as a decrease of systolic blood pressure by more than 30% from baseline or a fall below 90 mmHg, was treated with IV boluses of ephedrine 5 mg and IV fluid as required. Bradycardia, defined as heart rate < 60 bpm, was treated with IV atropine 0.6 mg. The incidence of adverse effects, such as nausea, vomiting, shivering, pruritus, respiratory depression, sedation, and hypotension was recorded.

 
Close