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To Study The Effects Of Addition Of Nalbuphine To
Bupivacaine Used For Elderly Patients Undergoing
Spinal Anaesthesia: A Randomized Double Blind,
Controlled Study


  Authors

 Dr. (Mrs) M.M.Panditrao
 CONSULTANT,
 ANESTHESDIOLOGY,
 Rand Memeorial Hopsital
 Freepeort, Grand Bahama
 The Bahamas
INTRODUCTION

• Spinal Anaesthesia: still the most popular
  technique

• However there is limitation of duration
• Many adjuvants have been used to prolong the
  duration/ provide analgesia, but have their own
  disadvantages
AIMS & OBJECTIVES
To compare -
• Quality of block
• Duration of post-operative analgesia
• Adverse effects, if any
 when Nalbuphine was added to Hyperbaric
Bupivacaine 0.5%, in patients undergoing lower
abdominal & lower limb surgeries.
MATERIAL & METHODS
• IEC approval
• Informed consent
• 40 ASA I & II
• Age range: 50-70 yrs
• Either sex
• Patients scheduled for lower abdominal &
  lower extremity surgeries (<180 min)
• Patient not fit for Spinal anaesthesia were
  excluded
• Thorough pre-operative evaluation
• NBM for 6-8 hrs
• Randomization: 2 groups by lottery method-
 Group 1 (Study group):
  Inj. Bupivacaine (0.5%) 3 ml +
  Inj. Nalbuphine (0.5mg) 0.5 ml
  intrathecally
 Group 2 (Control group):
  Inj. Bupivacaine (0.5%) 3 ml +
  Inj. Normal saline 0.5ml intrathecally
• Sedatives and Hypnotics avoided in pre, intra &
  post-operative period
• IV line secured with 20 G cannula
• Preload: Ringer lactate @ 10ml/kg
• Monitoring: Pulse, B.P., SPO2, RR
• ↓ AAP, SAB given in     • Respective agents injected
  sitting position with     according to group
  26G Quincke needle
• Following parameters were observed -
1) Time of onset of sensory blockade (T1)

2) Time of onset of motor blockade (T2)

3) Time of peak sensory blockade (T3)

4) Time of peak motor blockade (T4)

5) Time of post-operative analgesia (T5)
• Fall in MAP>20% of basal value: Treated with
  Inj. Mephentermine

• Bradycardia, HR>20% fall from basal value or
  <55 bpm: Treated with Inj. Atropine

• Rescue analgesia: Inj. Tramadol 100mg or Inj.
  Diclofenac 75mg I.M.
RESULTS
                                                               Demographic profile of age

                                                          60




                                            Age (years)
                                                          40                                                               AM
                                                          20                                                               SD
                                                          0
                                                                 Group I                              Group II
                                                                           Groups


                                              P Value =0.666
                   • No significant difference in average Age in two groups
                       Male : Female distribution                                                                     ASA Grading
No. of patients




                                                                               No. of patients
                  15                                                                             20
                  10                                              Male                           15                                            I
                                                                                                 10
                  5                                               Female                                                                       II
                                                                                                  5
                  0                                                                               0
                        Group I            Group II                                                              Group I            Group II
                                  Groups                                                                                   Groups


       • There was no significant difference between two groups with
       respect to Sex and ASA grading
Onset Of Sensory & Motor Blockade

                    Onset of sensory                                             On set of Motor




                                                     Tim ( in Seconds)
                                                                         150
             80
Time (sec)




             60                                 AM                       100                                 AM
             40                                                                                              SD
                                                SD                       50
             20
              0                                                           0
                  Group I            Group II                                  group I            group II
                            Groups                                                       Groups



                     P Value =0.45                                               P Value =0.48


 • Time for onset of sensory & motor
   blockade in both groups was comparable
Peak Sensory & Motor Blockade

• Time for onset of peak sensory & peak
                          PEAK SENSORY                                                PEAK MOTOR
 TIME (SECONDS)




                                                            TIME (SECONDS)
 motor blockade in both groups
                  500
                  400
                                                                             300

                                                       AM                    200                                 AM

• was same
                  300
                  200                                  SD                    100                                 SD
                  100
                    0                                                         0
                         Group I            Group II                               Group I            Group II
                                   GROUPS                                                    GROUPS


                                   P = 0.96                                          P = 0.28


• Time for onset of peak sensory & peak motor
  blockade in both groups was similar
Duration Of Analgesia
                                         RESCUE ANALGESIA




            TIME (Minutes)
                             600
                             400                                               AM
                             200                                               SD

                               0
                                         Group I            Group II
                                                   GROUPS



PARAMETER                    GROUP I               GROUP II          P         SIGNIFICANCE
                             AM + SD               AM + SD         VALUE
                                                                                   Highly
   T5                        516 + 155         159.5 + 18.42           0.000     Significant



  • Mean time of post-operative analgesia (T5) in
   Study group (8 to 9 hrs) was highly significantly
   longer than in Control group (2 to 3hrs)
Comparison of pulse rate

                 90
    Pulse rate

                 85
                 80                                                Group I
                 75                                                Group II
                 70
                 65
                      0
                          3
                              15
                                   30
                                        45
                                             60
                                                  90
                                                       120
                                                             150
                                   Time (min)



•   Clinically not significant, but statistically
    slightly significant at 150 minutes
comparison of SBP

        150
                                                                 Group I
  SBP

        100
         50                                                      Group II
          0
                          ts


                                      ts


                                                  ts


                                                            ts
              ts
            in


                        in


                                    in


                                                in


                                                          in
        m


                    m


                                 m


                                            m


                                                       m
                                                      0
        0


                   15


                               45


                                           90


                                                   15
                               Time in minutes



• Statistically significant difference
  between two groups, but clinically
  insignificant
Comparison of DBP

         100
                                                 Group I
   DBP




         50
                                                 Group II
          0
               0


                    15


                             45


                                      90


                                           150
                         time (min)



• Statistically significant difference
  between two groups, but clinically
  insignificant
• Respiratory rate and SPO2 were almost similar
  in two groups and no difference found

• No adverse effects

• No morbidity
DISCUSSION

• SAB: Technique of choice for lower abdominal
   & lower extremity surgeries

• Since SAB with Bupivacaine has post-operative
  analgesia for short period, many adjuvants have
  been used in past to prolong it
• Present study: Nalbuphine 0.5 mg added as an
  adjuvant to Bupivacaine

• Duration of analgesia post-operatively
  - In Study group with added adjuvant
    Nalbuphine : 8 to 9 hours
  - In Control group with plain
    Bupivacaine: 2 to 3 hours
• Nalbuphine is a synthetic opioid with mixed agonist
  & antagonist properties

• Mechanism of analgesia: By its agonist action,
  Nalbuphine stimulates Kappa receptors which
  inhibits release of neurotransmitters like substance P
  that mediate pain.

• In addition it acts as a post-synaptic inhibitor on the
  interneurons & output neurons of the Spino-thalamic
  tract which transport nociceptive information
• In the Nalbuphine group , almost 25% of the
  elderly patients were controlled Hypertensives,
  however no cardio-pulmonary adverse effects
  were seen.
• Improved quality of block
• Prolonged & long lasting post-operative
  analgesia
• No adverse effects like other opioids ( respiratory
  depression, nausea, vomiting, pruritus)
• Cost effective
CONCLUSION
• Nalbuphine provides better quality of block
 as compared to Bupivacaine alone

• Nalbuphine provides post-operative analgesia
 for almost 8-9 hrs when used as an adjuvant
 to Bupivacaine

• From present study, we feel this is an excellent
  method of providing post-operative analgesia
  without any adverse effects for patient
  undergoing Surgery under SAB
THANK YOU
REFRENCES
• Stanley F Malamed; Neurophysiology in Hand book of local
 anesthesia 2nd Edition, Jaypee brothers: 1986:20
• Ready BL Acute perioperative pain. In Miller RD. Anaesthesia
5th Edition, Chruchill Livingstone, Philadelphia, 2000: 2323:50
• Park House J Simpson BRJ; The Problem of postoperative pain,
 BJA 1961; 33; 336-343 Atkinson, Rushman & Davies Lee’s
 synopsis of anaesthesia, 11th Edition,Butterwoth Heinemann
• Culebrasx Gaggero G, Zatloukal J, etal. Advantages of
intrathecal nalbuphine compared with intathecal morphine after
 cesarean delivery an evaluation of postoperative analgesia and
 adverse effect. Anesth Analg 2000; 91:601-5
  (Astract/Freefull Text)
• Lin ML. The analgesic effect of subarachnoid administration of
tetracaine combinedn albuphine for post operative pain relief
after total hip replacement [abstract]. Anesthesiology 1998;
 89: A867

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Nalbuphine given intrathecally as an adjuvant to LAAs

  • 1. To Study The Effects Of Addition Of Nalbuphine To Bupivacaine Used For Elderly Patients Undergoing Spinal Anaesthesia: A Randomized Double Blind, Controlled Study Authors Dr. (Mrs) M.M.Panditrao CONSULTANT, ANESTHESDIOLOGY, Rand Memeorial Hopsital Freepeort, Grand Bahama The Bahamas
  • 2. INTRODUCTION • Spinal Anaesthesia: still the most popular technique • However there is limitation of duration • Many adjuvants have been used to prolong the duration/ provide analgesia, but have their own disadvantages
  • 3. AIMS & OBJECTIVES To compare - • Quality of block • Duration of post-operative analgesia • Adverse effects, if any when Nalbuphine was added to Hyperbaric Bupivacaine 0.5%, in patients undergoing lower abdominal & lower limb surgeries.
  • 4. MATERIAL & METHODS • IEC approval • Informed consent • 40 ASA I & II • Age range: 50-70 yrs • Either sex • Patients scheduled for lower abdominal & lower extremity surgeries (<180 min) • Patient not fit for Spinal anaesthesia were excluded
  • 5. • Thorough pre-operative evaluation • NBM for 6-8 hrs • Randomization: 2 groups by lottery method- Group 1 (Study group): Inj. Bupivacaine (0.5%) 3 ml + Inj. Nalbuphine (0.5mg) 0.5 ml intrathecally Group 2 (Control group): Inj. Bupivacaine (0.5%) 3 ml + Inj. Normal saline 0.5ml intrathecally
  • 6. • Sedatives and Hypnotics avoided in pre, intra & post-operative period • IV line secured with 20 G cannula • Preload: Ringer lactate @ 10ml/kg • Monitoring: Pulse, B.P., SPO2, RR
  • 7. • ↓ AAP, SAB given in • Respective agents injected sitting position with according to group 26G Quincke needle
  • 8. • Following parameters were observed - 1) Time of onset of sensory blockade (T1) 2) Time of onset of motor blockade (T2) 3) Time of peak sensory blockade (T3) 4) Time of peak motor blockade (T4) 5) Time of post-operative analgesia (T5)
  • 9. • Fall in MAP>20% of basal value: Treated with Inj. Mephentermine • Bradycardia, HR>20% fall from basal value or <55 bpm: Treated with Inj. Atropine • Rescue analgesia: Inj. Tramadol 100mg or Inj. Diclofenac 75mg I.M.
  • 10. RESULTS Demographic profile of age 60 Age (years) 40 AM 20 SD 0 Group I Group II Groups P Value =0.666 • No significant difference in average Age in two groups Male : Female distribution ASA Grading No. of patients No. of patients 15 20 10 Male 15 I 10 5 Female II 5 0 0 Group I Group II Group I Group II Groups Groups • There was no significant difference between two groups with respect to Sex and ASA grading
  • 11. Onset Of Sensory & Motor Blockade Onset of sensory On set of Motor Tim ( in Seconds) 150 80 Time (sec) 60 AM 100 AM 40 SD SD 50 20 0 0 Group I Group II group I group II Groups Groups P Value =0.45 P Value =0.48 • Time for onset of sensory & motor blockade in both groups was comparable
  • 12. Peak Sensory & Motor Blockade • Time for onset of peak sensory & peak PEAK SENSORY PEAK MOTOR TIME (SECONDS) TIME (SECONDS) motor blockade in both groups 500 400 300 AM 200 AM • was same 300 200 SD 100 SD 100 0 0 Group I Group II Group I Group II GROUPS GROUPS P = 0.96 P = 0.28 • Time for onset of peak sensory & peak motor blockade in both groups was similar
  • 13. Duration Of Analgesia RESCUE ANALGESIA TIME (Minutes) 600 400 AM 200 SD 0 Group I Group II GROUPS PARAMETER GROUP I GROUP II P SIGNIFICANCE AM + SD AM + SD VALUE Highly T5 516 + 155 159.5 + 18.42 0.000 Significant • Mean time of post-operative analgesia (T5) in Study group (8 to 9 hrs) was highly significantly longer than in Control group (2 to 3hrs)
  • 14. Comparison of pulse rate 90 Pulse rate 85 80 Group I 75 Group II 70 65 0 3 15 30 45 60 90 120 150 Time (min) • Clinically not significant, but statistically slightly significant at 150 minutes
  • 15. comparison of SBP 150 Group I SBP 100 50 Group II 0 ts ts ts ts ts in in in in in m m m m m 0 0 15 45 90 15 Time in minutes • Statistically significant difference between two groups, but clinically insignificant
  • 16. Comparison of DBP 100 Group I DBP 50 Group II 0 0 15 45 90 150 time (min) • Statistically significant difference between two groups, but clinically insignificant
  • 17. • Respiratory rate and SPO2 were almost similar in two groups and no difference found • No adverse effects • No morbidity
  • 18. DISCUSSION • SAB: Technique of choice for lower abdominal & lower extremity surgeries • Since SAB with Bupivacaine has post-operative analgesia for short period, many adjuvants have been used in past to prolong it
  • 19. • Present study: Nalbuphine 0.5 mg added as an adjuvant to Bupivacaine • Duration of analgesia post-operatively - In Study group with added adjuvant Nalbuphine : 8 to 9 hours - In Control group with plain Bupivacaine: 2 to 3 hours
  • 20. • Nalbuphine is a synthetic opioid with mixed agonist & antagonist properties • Mechanism of analgesia: By its agonist action, Nalbuphine stimulates Kappa receptors which inhibits release of neurotransmitters like substance P that mediate pain. • In addition it acts as a post-synaptic inhibitor on the interneurons & output neurons of the Spino-thalamic tract which transport nociceptive information
  • 21. • In the Nalbuphine group , almost 25% of the elderly patients were controlled Hypertensives, however no cardio-pulmonary adverse effects were seen. • Improved quality of block • Prolonged & long lasting post-operative analgesia • No adverse effects like other opioids ( respiratory depression, nausea, vomiting, pruritus) • Cost effective
  • 22. CONCLUSION • Nalbuphine provides better quality of block as compared to Bupivacaine alone • Nalbuphine provides post-operative analgesia for almost 8-9 hrs when used as an adjuvant to Bupivacaine • From present study, we feel this is an excellent method of providing post-operative analgesia without any adverse effects for patient undergoing Surgery under SAB
  • 24. REFRENCES • Stanley F Malamed; Neurophysiology in Hand book of local anesthesia 2nd Edition, Jaypee brothers: 1986:20 • Ready BL Acute perioperative pain. In Miller RD. Anaesthesia 5th Edition, Chruchill Livingstone, Philadelphia, 2000: 2323:50 • Park House J Simpson BRJ; The Problem of postoperative pain, BJA 1961; 33; 336-343 Atkinson, Rushman & Davies Lee’s synopsis of anaesthesia, 11th Edition,Butterwoth Heinemann • Culebrasx Gaggero G, Zatloukal J, etal. Advantages of intrathecal nalbuphine compared with intathecal morphine after cesarean delivery an evaluation of postoperative analgesia and adverse effect. Anesth Analg 2000; 91:601-5 (Astract/Freefull Text) • Lin ML. The analgesic effect of subarachnoid administration of tetracaine combinedn albuphine for post operative pain relief after total hip replacement [abstract]. Anesthesiology 1998; 89: A867