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1. A COMPARISION OFANALGESIC EFFECT OF TWO
DIFFERENT DOSES OF INTRATHECAL NALBUPHINE
HYDROCHLORIDE WITH 0.5% HYPERBARIC BUPIVACAINE
FOR LOWER ABDOMINAL SURGERIES
A Synopsis
Submitted for the award of MD degree
By
Dr Nayak Rakshat
Under guidance of
Dr. Mahesh
Faculty of Medical Sciences
Department of Anaesthesiology
Pacific institute of medical sciences
Tirupati University, Udaipur
(2022-2025)

2. INTRODUCTION
• Subarachnoid blockade is a common anesthetic technique for lower
Abdominal and lower limb surgeries.
• The major problem is post operative pain,
• Adding adjuvant drugs to intrathecal local anesthetics improves the
quality and duration of the sensory blockade and prolongs
postoperative analgesia.
• Intrathecal opioids are synergistic with local anesthetics, there by
intensifying the sensory block without increasing sympathetic block

3. • Nalbuphine is a synthetic highly lipid-soluble opioid analgesic
• It has an agonist action at the κ-opioid receptor and antagonist
action at the μ-opioid receptor to provide reasonably potent
analgesia of visceral nociception
• Intrathecal nalbuphine produces lesser adverse effects like
pruritus, nausea, and vomiting when compared to intrathecal
morphine
• It does not cause any significant hemodynamic or respiratory
complications
• Here we will study the comparision of two different doses of
intrathecal nalbuphine hydrochloride with 0.5% hyperbaric
bupivacaine

4. AIM AND OBJECTIVES
Aim
To compare analgesic effect of two different doses of intrathecal
nalbuphine hydrochloride with 0.5% hyperbaric bupivacaine for lower
abdominal surgeries
OBJECTIVES
1.comparing the onset time of sensory block
2.comparing the onset time motor blockade
3.comparing the time taken to reach peak sensory and motor
level
4.comparing the total duration of analgesia

5. MATERIALS AND METHOD
Study location : The study will be conducted in the Department of
Anaesthesiology, Pacific Institute of Medical Sciences, Umarda ,
Udaipur.
Study design : Double blinded Randomized controlled study
Sample size:
Total 150 patients will be selected for elective surgery under spinal
anaesthesia patients will be randomized into three groups with 50
patients in each group using following formula
Formula: where n=Sample size
Z=1.96 (standard value)
SD=0.49 (standard deviation)
L=0. 12 (length of confidential interval)

6. • Randomization
The patients will be randomly assigned into 3 groups including 50
patients in each group by “closed envelope” technique
Group A (n= 50) will receive 0.5% hyperbaric bupivacaine
3ml(15mg)+0.5ml normal saline.
Group B(n=50) will receive 0.5% hyperbaric bupivacaine
3ml(15mg)+0.8 mg nalbuphine hydrochloride
Group C (n=50)will receive 0.5% hyperbaric bupivacaine
3ml(15mg)+1..6 mg nalbuphine hydrochloride
EQUIPMENT AND DRUGS
Spinal needle 25G (Quincke’s type)
hyperbaric bupivacaine 0.5% (5mg/ml)
nalbuphine hydrochloride( 0.8mg and 1.6mg)

7. • SCALE USED
• Visual Analogue Scale (VAS)
• 1-3 = mild pain
• 4-6 = moderate pain
• 7-10 = severe pain
MODIFIED BROMAGE SCALE
• GRADE 0-patient is able to move hip,knee and ankle and is able to
lift leg
• GRADE1-patient is not able to lift leg but can flex the knee and
ankle
• GRADE2-patient is not able to flex the knee but is able to flex ankle
• GRADE3 –patient is not able to flex the hip knee and ankle but can
flex toes
• GRADE4-complete paralysis

8. • INCLUSION CRITEREA
• Patients age 18-75 yrs
• ASA grade I and II
• Weight 40 to 80 kg
• Posted for elective lower abdominal surgeries
• EXCLUSION CRITEREA
• Patient refusal
• Any deformity or local stenosis in lumbar region
• Severe hypovolemia, increased intracranial pressure
• History of allergy to local anaesthetic
• Coagulopathy
• Infection at the site of injection
• Severe stenotic valvular heart disease
• Vertebral deformities

9. METHOD
• One day before surgery, a detailed pre anesthetic evaluation will be
done
• The procedure of spinal anesthesia and VAS score will be explained
to the patient and written informed consent will be obtained
• On the day of surgery, intravenous cannulation will be done and
baseline parameteres (MAP,HR,spo2) will be noted

10. • Patient will be randmized using close envelope technique method
• Group A(N=50) – will receive hyperbaric bupivacaine 0.5% 3ml
(15mg) + 0.5ml normal saline
• Group B(N=50) – will receive hyperbaric bupivacaine 0.5% 3ml
(15mg) + 0.8 mg nalbuphine hydrochloride
• GroupC(N=50)– will receive hyperbaric bupivacaine 0.5%
3ml(15mg)+1.6mg nalbuphine hydrochloride
• spinal anesthesia will be administered at L3-L4 interspace using 25
G Quincke’s spinal needle.
• The study drug will be injected according to the group.
.

11. • Sensory block will be assessed by loss of sensation to pinprick in the
midline with an 18 G blunt needle from below upwards.
• Onset time to reach level T10 and highest level will be noted.
• Motor blockade will be assessed according to a modified bromage
scale.
• Onset time to reach grade 1 will be noted.

12. • The hemodynamic variables will be recorded every 5 min for first
30 minutes and thereafter every 15 minutes until the end of the
procedure.
• In postoperative unit, patients will be monitored for hemodynamic
parameters every 2 hour until the sensory and motor variables will
be back to normal.
• The patients will be asked to assess their level of pain according to
the VAS every 15 min for 120 min, then half hourly for 180 min,
hourly for 12 h, and thereafter every 3 h till 24 h both groups.

13. REVIEW OF LITRATURE
Mahnaz S Shah et al in 2022 conducted a study on 60 female patient
Nalbuphine as an Intrathecal Adjuvant to 0.5% Hyperbaric Bupivacaine
in Two Different Doses 1.6 mg and 2.4 mg for Postoperative Analgesia
After Abdominal Hysterectomy and concluded that intrathecal
nalbuphine in a 1.6 mg dose is an effective adjuvant to 0.5% hyperbaric
bupivacaine for SAB. It potentiated the SAB characteristics and enhanced
the duration of analgesia with no effect on respiration. Nalbuphine in a
dose of 2.4 mg did not offer any added advantage.
Bindu Nagraj et al in 2022 conducted a study on 60 patient Nalbuphine
and Dexmedetomidine as Adjuvants to Bupivacaine versus Plain
Bupivacaine for Orthopedic Surgeries under Subarachnoid Block in two
different doses 2.7 mL of 0.5% hyperbaric bupivacaine with 1.5 mg
nalbuphine and 2.7 mL of 0.5% hyperbaric bupivacaine with 10 μg
dexmedetomidine, and 2.7 mL of 0.5% hyperbaric bupivacaine with 0.5
mL of normal saline and concluded that the Intrathecal dexmedetomidine
acts as a better adjuvant with bupivacaine in providing quality anesthesia,
prolonged sensory and motor block, and good postoperative analgesia
with less incidence of adverse effects compared to nalbuphine and
bupivacaine alone.

14. Abdelrady S Ibrahim et al in 2019 conducted a study on 80 patient
Effect of adding nalbuphine to intrathecal bupivacaine with morphine
on postoperative nausea and vomiting and pruritus after elective
cesarean delivery with dose 10 mg of 0.5% hyperbaric bupivacaine
with 0.2 mg morphine and 0.5mg nalbuphine And concluded that
addition of nalbuphine to intrathecal bupivacaine plus morphine
significantly reduced the incidence and severity of postoperative nausea
and vomiting and pruritus without affecting analgesic potency.
Shagufta Naaz, et al in 2017 conducted a study on 90 patient
comparison of Analgesic Effect of Intrathecal Nalbuphine and
Fentanyl as Adjuvant Each group received 12.5 mg of 0.5% of
injection bupivacaine heavy along with either 25 μg of 0.5 ml fentanyl
(Group F) or 0.8 mg of 0.5 ml nalbuphine (Group NL) or 1.6 mg of 0.5
ml nalbuphine (Group NH) and concluded that There was no
significant advantage of intrathecal fentanyl or 1.6 mg nalbuphine over
low dose 0.8 mg nalbuphine.

15. Akhilesh Kumar Tiwari et al in 2013 conducted a study on 75 patient
Intrathecal bupivacaine in comparison with a combination of nalbuphine
and bupivacaine intrathecally. In different doses 2.5 mL of 0.5%
hyperbaric bupivacaine + 200 mcg nalbuphine or 400mcg nalbuphine or
1ml sterile water and Concluded that Nalbuphine hydrochloride (400
μg) significantly prolongs the duration of sensory blockade and
postoperative analgesia without any side effect or complication when
introduced intrathecally along with hyperbaric bupivacaine
Arghya Mukherjee ,et al on 2011 conducted a study on 100 patient
Intrathecal nalbuphine as an adjuvant to subarachnoid block A, B, C and
D, to receive 0.5 ml normal saline (NS) or 0.2, 0.4 and 0.8 mg
nalbuphine made up to 0.5 ml with NS added to 0.5% hyperbaric
bupivacaine 12.5 mg (total volume 3 ml),respectively and Concluded
that Nalbuphine used intrathecally is a useful adjuvant in SAB and, in a
dose of 0.4 mg, prolongs postoperative analgesia without increased side-
effects.

16. • RESEARCH PROTOCOL PROFORMA
Pacific Institute of Medical Sciences; Department of Anesthesiology
Research Topic: comparison of analgesic effect of two different doses
intrathecal nalbuphine hydrochloride with 0.5% heavy bupivacaine
for lower abdominal surgery
Research Scholar: Dr Nayak rakshat
Research Guide: Dr Mahesh
Co Guide:
Name of patient: Date of admission:
Father's Name: Unit/Ward:
Age/sex: Diagnosis:
Address: ASA Grade I/II:
Email address: Date of operation:
Phone no: Proposed surgery:
Registration no: Surgery performed:

17. • Pre-anesthetic Check Up (Pac):
• General Physical Examination:
• BP: pulse: RR: SpO2
• Pallor /cynosis/ edema/ icterus
• Systemic Examination:
• Cardiovascular system-
• Central Nervous system-
• Respiratory system-
• Gastrointestinal system-

18. • Investigations:
• Chest X-ray-PA view: ECG:
• Blood Investigations:
• Hb: TLC:
Platelet Count:
• BT: CT:
Blood Group:
• Serum electrolytes:
• Sodium: Potassium:
Chloride:
• Blood Urea: Serum Creatinine:
• SGOT: SGPT:
ALP:
• Blood Sugar:
• [Coagulation Profile: APTT: INR:

19. • Monitoring
• BASELINE PARAMETERES-
• H.R(bpm) MAP(mmhg)
• RR/minute SPO2(%)
• Block parameters
• Onset of sensory block (T10)-
• Onset of motor block(Grade-1)
• Time taken to reach highest sensory block and level-
• Time taken to reach complete motor block (Grade 3)-
• Total duration of surgery-
• Time taken for regression of sensory block(s1)
• Total duration of sensory block-
• Total duration of motor block-
• Time of first rescue analgesic-
• Total analgesia consumption-

20. TIME/
PARAMETER
PULSE
RATE
(/min.)
SBP/DBP
(mmHg)
M.A.P
(mmHg)
RESPIRATORY
RATE (/min.)
SpO2 (%)
EVERY 5 MIN.
FOR FIRST 15
MIN. AND THEN
EVERY 15 MIN.
TILL END OF
SURGERY
THEN 2nd
HOURLY IN THE
POST
OPERATIVE
PERIOD
TILLSENSORY
AND MOTOR
VARIABLES
BACK TO
NORMAL
HEMODYNAMIC
PARAMETERS

21. VAS SCORING
Time duration VAS score
Every 15mins for 2hrs
Every 30mins for 2.5hrs
Every 2ndhr for 12hrs
Every 3hr for 24hrs

22. INFORMED CONSENT FORM
Study Title: comparison of analgesic effect of two different doses intrathecal nalbuphine
hydrochloride with 0.5% heavy bupivacaine for lower abdominal surgery
Subject’s Name....................................................
Date of Birth/ Age (Years): ........ Sex: ………
(1) I confirm that I have been explained the purpose and the methodology of the study in the
language I understand and I have cleared every doubt about the study.
(2) I understand that my participation in the study is voluntary and that I am free to withdraw at
any time, without giving any reason, without my medical care or legal rights being affected.___
(3) I have been informed that this study is purely a research study and participation in the above
study would not be of any direct benefit or risk to me and results of this study may be of help in
future for the society. ___
(4) I understand that the investigator of this study and others working on the investigator’s behalf,
the Institutional Ethics Committee will not need my permission to look at my health records both
in respect to current study and any future research study that may be conducted in relation to it___
. (5) I
understand that my identity will not be revealed in any information released to third parties or
Published.___
• (6) I agree not to restrict the use of any data or result that arises from this study provided such
a use is only for scientific purpose.___
• (7) I agree to take part in the above study.___
• Name of the subject; ...........................................................
• Signature of the subject: .............................. Date:……………
• Name of the Investigator…………………………….....................
• Signature of the Investigator: ....................... Date:…………….

23. Refrences
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understanding and future trends. World J Clin Cases. 2017, 5:307-23.
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versus intrathecal fentanyl as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic
surgery of lower limbs under subarachnoid block: a comparative evaluation. Indian J
Pain. 2016, 30:90-5.
4) Gunion MW, Marchionne AM, Anderson TM: Use of the mixed agonist-antagonist
nalbuphine in opioid based analgesia. Acute Pain. 2004, 6:29-39.
5) Schmauss C, Doherty C, Yaksh TL: The analgetic effects of an intrathecally
administered partial opiate agonist, nalbuphine hydrochloride. Eur J Pharmacol. 1982,
86:1-7.
6) penning JP, Samson B, Baxter AD: Reversal of epidural morphine-induced
respiratory depression and pruritus with nalbuphine. Can J Anaesth. 1988, 35:599-
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7) Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA: Advantages of intrathecal
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24. 8) Seol Kim1, Byung Il Yoon, Su Jin Kim, Hyuk Jin Cho, Hyo Sin Kim, Sung Hoo Hong, Ji Youl
Lee, Tae-Kon Hwang Sae Woong Kim Effect of Oral Administration of Acetaminophen and
Topical Application of EMLA on Pain during Transrectal Ultrasound-Guided Prostate
Biopsy 2011 Jul;52(7):452-6
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Wongsirichat1 Pain measurement in oral and maxillofacial surgery 2017 Dec;17(4):253-263.
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Adjuvant to 0.5% Hyperbaric Bupivacaine in Two Different Doses for Postoperative Analgesia
After Abdominal Hysterectomy 2022 May 16;14(5).
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Dexmedetomidine as Adjuvants to Bupivacaine versus Plain Bupivacaine for Orthopedic
Surgeries under Subarachnoid Block: 2022 Jul-Sep;16(3):381-385.
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13) Shagufta Naaz, 1 Usha Shukla,2 Swati Srivastava,3 Erum Ozair,4 and Adil Asghar 5A
Comparative Study of Analgesic Effect of Intrathecal Nalbuphine and Fentanyl as Adjuvant in
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