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CTRI Number  CTRI/2022/03/040986 [Registered on: 10/03/2022] Trial Registered Prospectively
Last Modified On: 07/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the pain relieving effect of fentanyl alone vs combination of fentanyl and morphine after cessarean delivery 
Scientific Title of Study   Comparison of fentanyl alone vs combination of fentanyl and morphine as an adjuvant to 0.5% hyperbaric bupivacaine for spinal anaesthesia in patients undergoing elective cesarean section- A prospective Randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Athisaya Elango 
Designation  DNB ANESTHESIA TRAINEE 
Affiliation  Sri Ramakrishna hospital 
Address  Room no 3, 2nd floor, A-block, Sri Ramakrishna hospital, 395, Sarojini Naidu street, New Siddhapudur, Coimbatore

Coimbatore
TAMIL NADU
641044
India 
Phone  09445329451  
Fax    
Email  dr.athisaya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prabha Udayakumar 
Designation  Head of the Department, Anaesthesiology 
Affiliation  Sri Ramakrishna hospital 
Address  395, Sarojini Naidu street,BKB nagar, Coimbatore-641044
395, Sarojini Naidu street,BKB nagar, Coimbatore-641044
Coimbatore
TAMIL NADU
641044
India 
Phone  9791346959  
Fax    
Email  prabhadr01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Athisaya Elango 
Designation  DNB ANESTHESIA TRAINEE 
Affiliation  Sri Ramakrishna hospital 
Address  395, Sarojini Naidu street,BKB nagar, New Siddhapudur, Coimbatore.

Coimbatore
TAMIL NADU
641044
India 
Phone  09445329451  
Fax    
Email  dr.athisaya@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramakrishna Hospital, Coimbatore 
 
Primary Sponsor  
Name  Athisaya Elango 
Address  395, Sarojini road, BKB nagar, Coimbatore-641044 
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 Athisaya   Sri Ramakrishna Hospital  Room no:3, 2nd floor, Department of Anaesthesiology, A-block, Sri Ramakrishna Hospital, New Siddhapudur
Coimbatore
TAMIL NADU 		 9445329451

drathisaya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramakrishna Hospital Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fentanyl  Fentanyl 20 mcg added to 0.5% hyperbaric Bupivacaine (1.8 ml) Intrathecal route 
Comparator Agent  Fentanyl and morphine  Fentanyl 20 mcg plus morphine 50 mcg added to 0.5% hyperbaric Bupivacaine (1.8 ml) Intrathecal route 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patients who are giving consent
2. All term (>36 weeks) pregnant women
3. Patients with mild PIH, controlled gestational diabetes(ASA I and II)
4. Patients aged between 20-40 years
5. Singleton pregnancy
6. Patients who are coming for elective LSCS 
 
ExclusionCriteria 
Details  1. Patients not willing to give consent
2. Known allergy to amide local anesthetics, fentanyl and morphine
3. Patients with contraindications to sub arachnoid block.
4. Patients with cardiovascular disease, severe pre eclampsia, uncontrolled gestational diabetes,
coagulopathies(ASA III and above)
5. Skin infection at block areas
6. Deformities of spinal column
7. Emergency LSCS 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia  Baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   14/03/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   AIM: The aim of this study is to compare the effectiveness of fentanyl alone with combination of fentanyl and morphine added to intrathecal 0.5% hyperbaric bupivacaine on post operative analgesia in patients undergoing elective LSCS. PRIMARY OUTCOME: 1. To compare the duration of analgesia between the two groups. SECONDARY OUTCOME: 1. Requirement of rescue analgesic in the first 24 hours. 2. Incidence of adverse effects like nausea and vomiting, pruritus, sedation and respiratory depression between two groups. MATERIALS AND METHOD: STUDY DESIGN: A prospective randomized control trial. STUDY SITE: Sri Ramakrishna Hospital, Coimbatore. STUDY DURATION: 6 months INCLUSION CRITERIA: 1. Patients who are giving consent 2. All term (>36 weeks) pregnant women 3. Patients with mild PIH, controlled gestational diabetes(ASA I and II) 4. Patients aged between 20-40 years 5. Singleton pregnancy 6. Patients who are coming for elective LSCSEXCLUSION CRITERIA: 1. Patients not willing to give consent 2. Known allergy to amide local anesthetics, fentanyl and morphine 3. Patients with contraindications to sub arachnoid block. 4. Patients with cardiovascular disease, severe pre eclampsia, uncontrolled gestational diabetes, coagulopathies(ASA III and above) 5. Skin infection at block areas 6. Deformities of spinal column 7. Emergency LSCS SAMPLE SIZE: The sample size was calculated using the following formula With significance level (α) at 1% and power 90% and the expected mean difference between the two groups is 8 hrs (Time for 1st analgesic requirement post-surgery) nA- no. of samples in group F nB-no. of samples in group FM K-sampling ratio (1) σ-Standard deviation (4) µA- Group F mean (4.2) µB- Group FM mean (12.7) (Ref: Karaman S, Günüsen I, Uyar M, Biricik E, Firat V. The effects of morphine and fentanyl alone or in combination added to intrathecal bupivacaine in spinal anesthesia for cesarean section. Agri 2011 Apr 1;23(2):57-63.) Applying these values in the above formula, sample size required is 40 subjects in each group.METHODOLOGY: The study will be initiated after getting approval from the Institutional Ethics Committee. 80 patients aged between 20-40 years, coming for elective LSCS under spinal anesthesia, who fulfill the selection criteria will be enrolled for the study. All patients will undergo pre anesthetic evaluation. Informed written consent will be taken and they will be assigned into two groups, Group F and Group FM by computer generated random numbers. patients in Group F will be receiving intrathecal fentanyl(20mcg) as an adjuvant to 2ml of 0.5 %hyperbaric bupivacaine and patients in Group FM will be receiving intrathecal fentanyl (20mcg) and intrathecal morphine (50mcg) as an adjuvant to 2ml of 0.5 %hyperbaric bupivacaine. Volume standardization is not done as morphine will be <0.1 ml. All patients will be kept fasting, 6 hours for solids. In pre op holding area, Patients will be checked for fasting status and baseline blood pressure, pulse rate and saturation will be recorded. Patient is pre loaded with normal saline/ringer lactate solution 15ml/kg by securing an iv line using 18G cannula in pre op room. Patient will be shifted to operation theatre and connected to ASA standard monitors like electrocardiogram, pulse oximetry, non invasive blood pressure and baseline parameters will be recorded. Spinal anesthesia is performed with the patient in the sitting position under aseptic technique using 25- gauge spinal needle at either L3-L4 or L4-L5 interspace. After clear flow of cerebrospinal fluid, patients will be given study drug at the rate of 0.2ml/sec. After spinal anesthesia, patients will be placed in supine position with 15º left uterine displacement and the level of sensory loss to temperature will be determined. Surgery will be started only after a satisfactory blockade up to level of T4 is achieved. Oxygen at 6 L/ min flow will be administered via a face mask to the patient. IV Ondansetron 4mg will be given for all patients 5 minutes after giving spinal anesthesia. Motor block will be assessed by modified Bromage scale. Modified Bromage scale: 0- No motor block 1- Inability to raise extended leg, able to move knees and feet 2- Inability to raise extended leg and knee, able to move feet 3- Complete motor block. ECG, HR,SPO2, NIBP and RR will be monitored every minute for first 10 minutes and then every 5 minutes till the end of surgery. Hypotension was defined as a 20% reduction from baseline systolic blood pressure or systolic BP<90mmHg. If this occurred, patients were treated with a rapid infusion of 100ml of Hartmann’s solution and intravenous ephedrine 6mg boluses. When HR < 60 beats/ min, atropine 0.6mg iv will be given. Any adverse effects like nausea and vomiting(NVS- 0-3, 0- No nausea and vomiting,1- presence of nausea without vomiting,2- mild to moderate vomiting not requiring treatment,3- severe vomiting requiring treatment), pruritus(0-2,0-No pruritus,1- mild not requiring treatment,2-severe pruritus requiring treatment), sedation(SS 0-3, 0-patient awake, 1- mild drowsiness, 2- moderate drowsiness , easily awaken, 3- severe sedation), hypotension and respiratory depression will be recorded.After surgery patients will be transferred to post operative ward and paracetamol will be given 8th hourly for all the patients. Pain scores will be noted immediately after surgery and 2,4,6,12 and 24 hours from induction of spinal anesthesia using Visual Analogue Pain Scale (VAS). The total number of patients requiring further analgesics, time to first demand of rescue analgesic and the amount of analgesics given in 24 hours will be noted in both the groups. Patients with vas score>4 will be given iv Diclofenac sodium 75mg as a rescue analgesic. For pruritus, iv Promethazine 50 mg will be given for score 2. Severe vomiting, which is more than two episodes will be treated with iv Metoclopropamide 10 mg.⁹ STATISTICAL ANALYSIS: Statistical analysis will be done using GraphPad Instat software. Summary statistics will be derived for all the data collected in the study. Scores of VAS between the groups will be compared using Wilcoxon rank sum test / Mann Whitney ‘U’ test. The number of analgesic doses used after surgery will be statistically compared using unpaired t-test. Chi-square analysis will be done for comparing the number of patients requiring analgesics within 24 hours and for comparing adverse events between the groups. The level of significance will be kept at 1% (p-value<0.001 will be considered significant) 
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