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http://jmscr.igmpublication.org/home/ ISSN (e)-2347-176x ISSN (p) 2455-0450 DOI: https://dx.doi.org/10.18535/jmscr/v8i2.158

A randomized comparative study between Bupivacaine and Midazolam combination with Bupivacaine alone in spinal blockage to evaluate post operative analgesia

Authors Dr Sohail Ahmad1, Dr Md. Mohsin2, Dr Rakesh Kumar Singh3 1Asst. Professor, Dept. of Anesthesia, K.M.C., Katihar 2Asst. Professor, Dept. of Anesthesia K.M.C., Katihar 3Professor, Dept. of Anesthesia, K.M.C., Katihar

Introduction intrathecal or extradural drug administration. In India surgery for lower lib, perennial region Regional analgesia has fewer side effects compare and lower abdominal commonly done by regional to systemic analgesia. One of the methods of central nuro-axial block. Spinal anesthesia is safer providing effective postoperative analgesia is by option for lower abdomen, perineal and lower prolonging the duration of intrathecal limb surgery. Bupivacaine is the most widely used bupivacaine by additives such as opioids, drug for spinal anesthesia, however in higher clonidine, ketamine, midazolam⁽ ²’³’⁴ ’⁵ ⁾ etc. doses it is associated with various complications. However, each drug has its own limitations and a To keep the dosage of bupivacaine, minimum and need for alternative methods. reduce the side effects, various adjuvant have Discovery of benzodiazepine receptors in spinal been tried to improve the sensory and motor cord triggered the use of intrathecal midazolam blockade for analgesia⁽ ⁶ ⁾ .Midazolam is known to Pain is a sensory-physical and emotional produce antinociception and potentiate the effect experience, it is always worry both patient and of local anesthetic when given in neuraxial block clinician. Issue of postoperative pain still not without having significant side effects. completely resolved. Due to pain, postsurgical Midazolam is a short-acting, potent, water-soluble patients are often unable to, move enough to their benzodiazepine. It has been used for potentiating own daily needs or participate in their own the analgesic effect of local anesthetic-induced rehabilitation. Postoperative pain relief helps in neuraxial blockade. Spinal analgesia effect of early mobilization of the patient good outcome, midazolam is mediated by benzodiazepine – reduced morbidity and patient satisfaction. gamma aminobutyric acid (GABA) receptor There are various methods used to relieve pos- complex which is abundantly present in the dorsal operatives pain such as postoperative oral opioids, horn of spinal cord with high density found in parenteral drugs, local infiltration of drug, lamina II of dorsal horn ganglia. Midazolam also

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acts on kappa or delta opioid receptors which are Inclusion Criteria also present in substantia gelatinosa of the spinal 1. Patients belonging to American Society of cord. Anaesthesiologists physical status I and II Hence, we planned this study to further assess 2. Patients undergoing elective lower midazolam in spinal blockage for prolong abdominal, Perennial and lower limb postoperative analgesia and we conducted surgery under spinal anaesthesia randomized, comparatives study of intrathecal 3. Anticipated duration of surgery less than 2 h midazolam – bupivacaine combination with 4. Age group between 18 and 60 years bupivacaine alone in spinal blockage for Hemodynamically stable postoperative analgesia. Exclusion Criteria Aims and Objective 1. Patient refusal Primary Aim 2. Patients with known neurological and  To study the effect of midazolam added to psychiatric disorders bupivacaine on onset, duration of motor & 3. Patients with gross spinal deformity sensory block and post operative 4. Patients on sedatives, hypnotics, analgesia antidepressants, and drugs with effects on Secondary Aim the nervous system  to study the hemodynamic parameters and

side effects due to addition of midazolam Preoperative vitals (HR, NIBP, ECG, SpO2) were recorded Material & Method Preloading with ringer lactate @ 10ml/kg through Study design: prospective, randomized controlled 18G IV cannula trial Spinal anaesthesia was administered in L3-L4 Blinding: the participant, the observer and the interspace using a 25G Quincke’s needle person doing the analysis were blinded The level of sensory block assessed using loss of Institutional ethical committee clearance was sensation to pin prick using a needle of 20 G obtained and informed consents from patients, Motor block assessed by using modified Bromage taken scale Sample Size: 40 patients, divided randomly into Onset of sensory block was defined as block up to two groups of 20 each, using a random number T10 level table Onset of motor block was defined as attainment of 1. Group BM(n=20): bupivacaine (0.5%) 3 Bromage scale-3 ml plus 0.2 ml midazolam (1 mg) Duration of analgesia was recorded from its onset 2. Group B(n=20): received bupivacaine of block to the time when the first recue analgesia (0.5%) 3 ml plus 0.2 ml normal saline was given Allocation concealment was done using sealed Duration of sensory block- abatement up to S5 envelope technique level This study was carried out in our institute (Katihar Duration of motor block- abatement up to Medical College) over period of 3 months, from Bromage-0 December 2019 to February 2020.

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 Rescue analgesia was given with Inj.  SPSS 20 was used for statistical analysis; Tramadol 100 mg IV when VAS was ≥4 Student t test for continuous variable and or the patient complained the pain Chi square test applied  Assessment was done at 0 hr, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6hr, 7hr, 8hr and 9 hr postoperatively

Results & Discussion

Group-BM Group-B PARAMETER (n=20) (n=20) P - value SIGNIFICANCE [MEAN SD] [MEAN SD] AGE 39.55 11.26 39.30 9.43 0.706 NS (in years) SEX 13:7 10:10 0.605 NS (F:M) HEIGHT 59.25 6.73 155.73 7.79 0.751 NS (in cm) WEIGHT 51.37 7.36 56.75 8.28 0.320 NS (in kg) DURATION 92.4 8.77 89.15 10.42 0.293 NS OF Sx (min) ASA 1.65 0.489 1.60 0.503 0.752 NS (grade I/II)

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Onset of Sensory block Onset of motor block

5.00 5.40 4.50 5.30 4.00

3.50 5.20

3.00 5.10

2.50 onset of Sensory 5.00 onset of motor block block 2.00 4.90 1.50

1.00 4.80

0.50 4.70

0.00 BM B

BM B

Duration of sensory block Duration of motor block

190.00 148.00

146.00 185.00 144.00 180.00 142.00

175.00 140.00

138.00 170.00 Duration of Duration of motor 136.00 sensory block block 165.00 134.00

132.00 160.00 130.00 155.00 128.00

150.00 126.00

BM B BM B

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3.50

3.00

2.50

2.00

Intensity 1.50 B

1.00

0.50

0.00

1 2 3 4 5 6 7 8 9 Time(hours)

100

50 BM

Heart rate Heart 40 B

B 0 2 4 6 8 10 20 40 60 80 100 Time(minute)

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100

50 BM

40 B

1 2 3 4 5 6 7 8 9

Variables Group BM Group B p value HS/NS* (mean±SD) (mean±SD)

Onset of motor block 4.95±1.317 5.35±1.309 .341 NS (min) Onset of sensory 3.35±.852 4.72±1.236 .000 HS block(min) Duration of surgery 92.40±8.774 89.15±1.429 .293 NS (min) Duration of sensory 187±13.328 165.50±14.307 .000 HS block (min) Duration of motor 145±13.400 132.70±10.418 .002 S block (min) Ramsay sedation 2.30±0.733 2.10±0.788 .411 NS score Duration of analgesia 340±49.139 189.10±44.032 .000 HS (min)

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Complication Group BM Group B

Nausea 2(10%) 1(5%)

Vomiting 0 1(5%)

Hypotension 1(5%) 1(5%)

Conclusion 3. Faull RLM, Villiger JW. Benzodiazepine 1) Addition of midazolam to bupivacaine receptors in human spinal cord : A detailed prolongs the duration of sensory block, anatomical and pharmacological study. motor block and effective analgesia Neuroscience 1986 ; 17: 791-802. without affecting the level of sensory 4. Agrawal N, Usmani A, Sehgal R, Kumar block suggesting thereby, that the dose R, Bhadoria P. Effect of intrathecal requirement of bupivacaine and post- midazolam bupivacine combination on operative analgesia can be reduced by the post op analgesia. Indian J Anaesth addition of midazolam in order to keep its 2005;49:37-9. undesired effects. 5. Valentine JM, Lyons G, Bellamy MC. The 2) No serious adverse effects were observed effect of intrathecal midazolam on post- with dose of midazolam used. However, operative pain. Eur J Anaesthesiol more studies are needed to define the ideal 1996;13:589-93 dose of midazolam for better results. 6. Bhattacharya D, Biswas B, Banerjee A. Intrathecal midazolam with bupivacaine References increases the analgesic effect of spinal 1. Mohler H, Okada T. Benzodiazepine blockade after major gynaecological receptor: Demonstration in central nervous surgery. J Anaesth Clin Pharmacol system. Science 1977; 198: 849-51. 2002;18:183-6. 2. Venkateswaran R, Prasad KN. 7. Vaswani RK, Raiger LK, Bajaj P. h e ef Management of post op pain. IJA 2006; ect of intrathecal midazolam on 50:345-54. postoperative pain relief in orthopedic surgery. Hosp Today 2002;4:217-20.

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