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CTRI Number  CTRI/2021/08/035557 [Registered on: 10/08/2021] Trial Registered Prospectively
Last Modified On: 02/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparative study between intrathecal nalbuphine and fentanyl 
Scientific Title of Study   A Randomized comparative study between intrathecal nalbuphine and intrathecal fentanyl with hyperbaric bupivacaine for lower abdomen and lower limb elective surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siddharth Chakraborty 
Designation  Senior Resident  
Affiliation  NRS Medical college & Hospital 
Address  NRS Medical College & Hospital. Department of Anaesthesia. Academic Block.
Kolkata, West Bengal.
Kolkata
WEST BENGAL
700014
India 
Phone  8340780971  
Fax    
Email  siddharthchakraborty318@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipankar Mukherjee 
Designation  Professor 
Affiliation  NRS Medical college & Hospital 
Address  Department of anaesthesia. Academic Block. NRS medical college and hospital. 138, AJC Bose Road.

Kolkata
WEST BENGAL
700014
India 
Phone  8240427859  
Fax    
Email  dipankarmukherjee096@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surjyendu Ghosh 
Designation  Senior Resident 
Affiliation  AIIMS, NEW DELHI 
Address  Department of Onco-anaesthesia, Pain & Palliative care. DrBRAIRCH. AIIMS, New Delhi.

New Delhi
DELHI
110029
India 
Phone  09874915509  
Fax    
Email  surja.rgkmch@gmail.com  
 
Source of Monetary or Material Support  
NSR Medical College & Hospital. Department of Anaesthesia. 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Siddharth Chakraborty  NRS Medical College & Hospital  Department of Anaesthesia. Academic Block. 138, AJC Bose Road. Kolkata- 700014.
Kolkata
WEST BENGAL 		 8340780971

siddharthchakraborty318@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NRS Medical college  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, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Subarachnoid block  Normal Salaine 0.5 ml 
Intervention  Subarachnoid block  Using 20 mcg fentanyl and 1.0 mg nalbuphine, intrathecally (sub arachnoid space), single dose. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) ASA physical status of I &II of either sex
b) age range 18-60 yrs
c) posted for elective surgery of lower abdomen or lower limbs under spinal anesthesia 
 
ExclusionCriteria 
Details  a)Patient refusal
b)Known history of allergy to drugs under study
c)ASA physical status III or more
d)patient is on anticoagulant(s)
e)patient having sepsis or local site infection
f)patient with known cardiovascular disease
g)patient with diabetes mellitus
h)patient having other contraindications for spinal anaesthesia
i)pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
the time of onset of the sensory block, motor block and duration of complete and effective analgesia between three groups  after SAB, every 5minutes 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   16/08/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
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 preferred technique for most of the lower abdomen & lower limb surgeries. Hyperbaric bupivacaine 0.5% is extensively used for spinal anaesthesia. Though the duration of action of bupivacaine is enough for intermediate duration surgery, it will not produce prolonged postoperative analgesia.Opioids are routinely added to local anaesthetics to prolong their duration of action in the postoperative period. Central neuraxial opioids, intrathecal as well as epidural,offer the perceived benefit of selective analgesia without sensory or mother blockade. Opioid analogues have been used as additive to Bupivacaine in spinal anaesthesia to improve the onset of action,quality of intraoperative & postoperative analgesia & to prolong the duration of block.

Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is agonist on kappa & antagonist on mu opioid receptors.

Fentanyl is a strong agonist of mu opioid receptors.It is derived from piperidine,an alkaloid chemical.Fentanyl is about 100 times more potent than morphine.
In the present study,we compared the effects of adding Fentanyl & Nalbuphine as an adjunct to hyperbaric bupivacaine in spinal anaesthesia for lower abdomen & lower limb surgeries.

The primary outcomes studied were effect on onset of sensory & motor blockade,duration of pain relief.Hemodynamic variables & side effects were also recorded.

Total no. of patients will be 90.All patients received a coded intrathecal drug volume of 3.5 ml.They was allocated as follows:-

Group I=(Control group)=15 mg of 0.5 % hyperbaric bupivacaine + 0.5 ml of normal saline

 

Group II=15 mg of 0.5% hyperbaric bupivacaine + Nalbuphine(1mg prepared into 0.5 ml)                                                                

Group III=15 mg of 0.5 % hyperbaric bupivacaine + Fentanyl{10 mcg prepared into 0.5 ml}

Difference of mean age in three groups was not statistically significant.Thus age was matched in three groups(p=0.9825).In group-I(C),12(40.0%) patients were females & 18(60.0%) patients were males.In group-II(N),8(26.7%) patients were females & 22(73.3%) patients were males.In group-III(F),8(26.7%) patients were females & 22(73.3%) patients were males.Association between gender in three groups was not statistically significant (p=0.4363).Association of ASA grade in three groups was not statistically significant (p=0.8752).Difference of mean height in three groups was not statistically significant (p=0.8640).Difference of mean weight in three groups was not statistically significant (p=0.5862).It was found that the mean time to achieve sensory block up to T10 level was (4.9150 ±0.9164) min. with range (3.40-6.90) min. & the median was 4.8750 min. in group-I (C).In group-II(N),the mean time to achieve sensory block up to T10 level was (3.4170±0.9139) min. with range (2.10-5.20) min. & the median was 3.3 min.In group-III(F),the mean time to achieve sensory block up to T10 level was (3.1813±1.2016) min. with range (1.08-5.40) min. & the median was 3.25 min.Hence time to achieve sensory block up to T10 level was least group-III(F) followed by group-II(N) & then group-I(C). Difference of mean time to achieve sensory block up to T10 level in three groups was statistically significant (p<0.0001).

It was found that the mean time to achieve Grade III motor block was (8.8463±2.8681) min. in Group I(C),(5.7803±1.5372) min. in Group II(N) & (6.4367±2.1485) min. in Group III (F).The mean time to achieve Grade III motor blockade was minimum in Group II(N) & maximum in Group I(C) showing a significant intergroup difference(p value< <0.0001).

The present study found that the mean duration of complete analgesia was found to be (128.9500±20.8328)min.,(182.3000±39.8732)min. & (192.6667±38.7408)min. in Groups I (C),II(N) & III(F) respectively.The mean duration of effective analgesia was found to be (155.0333±35.8892)min,(255.6000±39.6394)min. & (281.0667±47.1965) min. in Groups I (C),II(N) &III(F) respectively.Group I had significantly shorter duration of complete as well as effective analgesia as compared to Groups II & III (p value<0.0001).A significant difference was observed between Groups II & III for the mean duration of effective analgesia (p value<0.0001) with Group III showing significantly longer duration as compared to Group II.It means that the longest duration of both complete & effective analgesia was experienced by the patients receiving Fentanyl,followed by the patients receiving Nalbuphine.

We found that differences of fall of SBP from 0 min to 90 min time interval.At all these occasions the mean value was maximum in Group I(C) followed by Group II(N) & then Group III(F).It means that fall in SBP was maximum in patients receiving Fentanyl followed by patients receiving Nalbuphine but the differences were not statistically significant(p>0.05).

We found that differences of fall of DBP were observed from 0 min to 90 min time interval.At all these occasions the mean value was maximum in Group I (C) followed by Group II (N) & then Group III (F).It means that fall in DBP was maximum in patients receiving Fentanyl followed by patients receiving Nalbuphine but the differences were not statistically significant(p>0.05).

We found that differences of fall of MAP from 0 min to 90 min time interval.At all these occasions the mean value was maximum in Group I(C) followed by Group II(N) & then Group III(F).It means that fall in MAP was maximum in patients receiving Fentanyl followed by patients receiving Nalbuphine but the differences were not statistically significant(p>0.05).

Statistically,no significant intergroup difference of respiratory rate was observed at any time interval.(p>0.05)

At most of the times the mean value of SpO2 in all the three groups remained above 98%. There was no significant intergroup difference(p value>0.05).

 

In our study we found that there was no statistically significant intergroup difference observed among the three study groups regarding pulse rate throughout the study period (p value > 0.05).

We found that nausea/vomiting was observed 1 patient in Group I(C),3 patients in Group II(N) & 2 patients in Group III(F) but it was not statistically significant(p=0.5853).Pruritus was observed 2 patients in Group I(C),4 patients in Group II(N) & 5 patients in Group III(F) but it was not statistically significant(p=0.4843).Hypotension was observed in no patient in Group I(C),no patient in Group II(N) & 2 patients in Group III(F) but it was not statistically significant(p=0.1293).

We concluded that Fentanyl is a better choice as an adjunct to Bupivacaine in Spinal Anaesthesia than Nalbuphine in terms of onset of sensory block & duration of analgesia without any significant hemodynamic disturbances & side effects.

 
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