comparative study between intrathecal nalbuphine and fentanyl
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,
- Registration Number
- CTRI/2021/08/035557
- Lead Sponsor
- NA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 90
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method NA NA
Trial Locations
- Locations (1)
NRS Medical College & Hospital
🇮🇳Kolkata, WEST BENGAL, India
NRS Medical College & Hospital🇮🇳Kolkata, WEST BENGAL, IndiaDr Siddharth ChakrabortyPrincipal investigator8340780971siddharthchakraborty318@yahoo.in