An increasingly popular form of local anaesthetic block used in conjunction with multimodal analgesia for procedures affecting the anterior and lateral abdominal walls is the transverse abdominis plane (TAP) block. TAP block is now a "must-know" approach for postoperative pain management for these surgeries due to recent improvements in ultrasonography technology.[1] The majority of abdominopelvic procedures are frequently performed under spinal anaesthesia, and postoperative pain is seldom given enough attention. Additional analgesic regimens such as multimodal analgesia, long-acting spinal or systemic opioids, or regional analgesia are essential for the patient's general health. Nevertheless, drowsiness, nausea, vomiting, pruritus, urine retention, and respiratory depression are among the unfavorable consequences and side effects linked to systemic opioids. Therefore, investigating more secure, long-lasting non-opioid alternative methods of postoperative analgesia is crucial. Analgesia in the T6–L1 dermatomal region overlying the anterior abdominal wall is achieved by transverse abdominis plane (TAP) block [2, 3].[4] TAP blocking guided by ultrasound has a favourable safety profile and is simple to execute. Analgesia can be prolonged by adding adjuvants to local anaesthetics.[5] One such adjuvant that is frequently employed in regional procedures is dexmedetomidine, a selective alpha-2 adrenergic agonist.[6] It has been demonstrated that adding dexmedetomidine to bupivacaine extends the duration of the analgesic effect in the affected area.[7] In terms of delivering sufficient sedation, a protracted postoperative analgesia, and an early onset of sensory analgesia, dexmedetomidine is a superior neuraxial adjuvant than clonidine. [8] In order to block the sensory nerve supply to the anterolateral abdominal wall, which includes the abdominal skin, muscles, and parietal peritoneum, a local anaesthetic is deposited in the area between the internal oblique and transverse abdominis muscles. This anaesthetic target spinal nerves that originate from the T6 to L1 spinal roots.[9] Levobupivacaine is a frequently used local anaesthetic in regional anaesthesia because bupivacaine is more cardio- and neurotoxic.[10] However, in comparison to bupivacaine, its duration of action is shorter. Adjuvants such as dexamethasone, opioids, magnesium sulphate, ketamine, and dexmedetomidine have therefore been used to extend the duration of blockage;

However, each has its own adverse effects, such as drowsiness, nausea, and vomiting.[11] α2-adrenergic receptor agonists, such as dexmedetomidine, have been utilized for their sedative, analgesic, and anaesthetic sparing properties. In several localized blocks, dexmedetomidine has demonstrated its effectiveness in extending the duration of local anaesthetics.[12] Few research has been published in the literature utilizing dexmedetomidine in conjunction with levobupivacaine to inhibit TAP. The purpose of my research is to evaluate the effectiveness of dexmedetomidine as an adjuvant to levobupivacaine in TAP block for the treatment of pain.

Aims and objectives

To compare duration of analgesia of levobupivacaine and levobupivacaine plus Dexmedetomidine in USG guided Transvers abdominis plane block in patients undergoing abdominal and pelvic surgeries.

Objectives

1. To assess duration of analgesia of levobupivacaine in Transverse abdominis plane block in post-operative period.
2. To assess the duration of analgesia of Dexmedetomidine with levobupivacaine in Transverse abdominis plane block in postoperative period.
3. To compare Duration of maximum analgesia in the above two.

Study area-Tertiary care centre.

Study duration- 2 year

Sample size

80 patient -divided in two groups 40 in each group. M1=mean group 1=6.84

M2=mean group 2=3.50

S1=standard deviation =0.62

Z1 = 1.96 at 5% level of significance Z2 = 0.84 at 80% power of test Minimal sample size for study is,

N1 = 40 and n2 = 40

Study population

1. Age group of 18 to 60
2. ASA grade 1and 2
3. both male and female

Study design

This will be prospective observational study

INCLUSION CRITERIA:

1. ASA physical status I / II
2. Age 18 to 60
3. Patients undergoing abdomino-pelvic surgeries who have given informed
4. Both male and female gender

EXCLUSION CRITERIA:

1. ASA physical status III / IV
2. Patients with coagulation
3. History of allergy to local anesthetics
4. Patient refusal
5. Patient requiring conversion to GA Patient not fitting into inclusion criteria
6. pregnant women

Methodology

1. Patient of age group falling under ASA grade 1 and ASA grade 2 will be selected after approval from Ethical Committee.
2. Informed written consent will be taken from
3. This prospective, randomized trial will be done on 80 patients Of ASA I & II, posted for abdominal and pelvic The study population will be randomly divided into 2 groups of 40 patients in each group.
4. During pre-anaesthetic checkup, Patients will be assessed for any illness and all required laboratory investigations will be Checked.
5. TAP block procedure and visual analog scale (VAS) for pain assessment will be explained to all the patients. Procedure will be done according to required plan of anaesthesia
6. At the end of surgery, TAP block will be given using midaxillary approach, ultrasound linear probe will be transversely located on the anterolateral abdominal wall in mid axillary line between the lower costal margin and the iliac crest. Neurovascular plane between the internal oblique and transverse abdominis muscle identified and nerve block needle will be introduced in the plane of ultrasound probe directly under the probe and advanced until it reaches the plane between internal oblique and transverse abdominis muscle.

After negative aspiration study drug will be injected-

Group A will receive 18ml of levobupivacaine 0.25% + 2ml normal saline bilaterally. And group B will receive 18 ml of levobupivacaine0.25% + (1 μg/kg Dexmedetomidine diluted up to 2ml of normal saline bilaterally.

7. The study drug will be distributed in a dark oval form and the plane appears as hypoechoic space.
8. After successfully completing the planned procedure, patients will be transferred to the post anesthesia care unit (PACU). Time to request first analgesics, rescue analgesia requirements will be recorded.
9. Heart Rate (HR), MAP (mean arterial pressure) and SPO2 will be assessed. Assessment of pain will be done on visual analogue scale “VAS” (0=no pain and 10= worst possible pain). It will be recorded at 30min,1hr, 2hr,4hr,6hr, 8hr,12hr,16hr, 24hr in postoperative period

Groups:

Group L: 18 ml of levobupivacaine 0.25% +2ml normal saline will be given to 40 patients

Group LD: 18 ml of levobupivacaine 0.25% + 1 μg/kg Dexmedetomidine diluted up to 2ml of normal saline will be given to 40 patients

STASTICAL ANALYSIS:

The collected raw data will be presented in the master chart using MS-Excel.

The analysis of data will be done using MS-Excel and minitab-13 statistical software. Presentation of data- Frequency distribution table (percentage), graphical presentation Descriptive statistics- mean, Standard deviation, Minimum and Maximum Inferential statistics – paired‘t’ test and Unpaired ‘t’ test were used.

POSTOPERATIVE MONITORING

Heart rate, Blood pressure, Mean arterial pressure

EVALUATION OF PAIN- visual analogue scale for assessing pain

0-no pain

1-2—mild annoying pain

3-4 nagging, uncomfortable, troublesome pain

5-6. Distressing, miserable pain

7-8 intense, dreadful, horrible pain

9-10 worst possible, unbearable, excruciating pain

Monitoring proforma

Code no of patients-

Age- sex- weight-

General examination-

Systemic examination-

Investigation-

Diagnosis-

ASA grade-

Type and duration of surgery-

TIME

Heart rate

Blood pressure

Mean Arterial pressure

VAS scoring

Any            side effect

30min

1hour

2hour

4hour

6hour

8hour

12hour

16hour

24hour

The tertiary care centre approved this prospective randomized double blind case control research by the Hospital Ethical Committee and all patients gave their informed consent. This study included 80 patients who had procedures on their abdomens and pelvises. Two groups of forty people each were formed out of them. Bilateral ultrasound-guided TAP block was administered to both groups. The proper needle position and the distribution of the local anaesthetic solution in the neuro-fascial plane between the transversus abdominis and internal oblique muscles were determined using ultrasonography.

Group L received 18 ml of levobupivacaine 0.25% +2ml normal saline and Group LD received 18 ml of levobupivacaine 0.25% + 1 μg/kg Dexmedetomidine diluted up to 2ml of normal saline Following the block, the haemodynamic parameters include blood pressure, pulse rate, respiratory rate, oxygen saturation, and blood pressure. Using the VAS score, the effectiveness of the analgesic was tracked. From the moment the TAP block was performed until a VAS score of 4 was obtained, the length of analgesia was determined. Obtaining a VAS score of ≥4 was the main goal of the study.

In the present study in Group L 42.30 years mean age where in Group LD 39.18 years mean age was observed. Statistically no significant difference was observed in age between both groups. (p=0.26). In Group L 55% were male cases and 45% were female cases whereas in Group LD 47.5% were male cases and 52.5% were female cases.

In the present study in Group L 40% cases were seen with ASA Grade I and 60% cases with ASA Grade II whereas in Group LD 45% cases were seen with ASA Grade I and 55% cases with ASA Grade II. [table- 1]

Table 1: ASA Grade

In our study at any interval statistically no significant difference was observed in HR between both groups. We studied at interval of 30min, 2hrs, 4hrs, 6hrs, 8hrs, 12hrs, 16hrs and 24hrs.

Table 2: Heart rate

We studied MAP at interval of 30min, 2hrs, 4hrs, 6hrs, 8hrs, 12hrs, 16hrs and 24hrs, At any interval statistically no significant difference was observed in MAP between both groups.

Table 3: VAS

In the present study in Group L 6.63 mean time for analgesia was observed where in Group LD 12.85 mean time for first analgesia was observed. Statistically significant difference was observed in time for first analgesia between both groups.

Table 4: Adverse side effects

Pain is one of the five critical symptoms that need to be watched during the post- operative period. Pain is an unpleasant emotion or sensation linked to real or imagined muscle tissue damage. Post-operative analgesia is essential for lowering the possibility of complications after surgery. So, it is essential to give patients appropriate pain treatment following surgery. This promotes early mobilization, reduces length of hospital stay, and raises patient satisfaction levels all around.[13] Although opioids are effective in treating post-operative pain, they can also have negative effects related to dosage, including respiratory depression, sleepiness, itching, nausea, and vomiting. Consequently, a regional nerve block has been proposed as a more effective way to improve analgesia after invasive procedures.

After abdominal surgeries, a transversus abdominis plane (TAP) block is a common technique for post-operative pain management. The internal oblique muscle, which is found in the TAP, and the transverse abdominis muscle may have anatomical gaps between them. A TAP block is a field block created by TAP invasion.[14] They offer anterolateral abdominal wall sensory blocking. The anterior abdominal wall's visceral peritoneum is not anaesthetised by it.[15] A TAP block is required for any procedure that involves the lower abdomen, including prostatectomy, hysterectomy, laparoscopic surgery, appendectomy, caesarean section, and hernia repair.[16] Because levobupivacaine, the s-isomer of bupivacaine, has less cardiotoxic and neurotoxic effects and a better haemodynamic profile, it is frequently utilized in regional nerve blocks. Research indicates that adjuvants, like dexmedetomidine, when used with local anaesthetics improve the block's effectiveness.[17] Very little study has been done on the combination of levobupivacaine and adjuvant dexmedetomidine up to this point.

Age

In the present study in Group L 42.30 years mean age was observed where in Group LD 39.18 years mean age was observed. Statistically no significant difference was observed in age between both groups. (p=0.26). In study done by Dhanashree PJ et al[18], There was no statistically significant difference in age group

Gender

In the present study In Group L 55% were male cases and 45% were female cases whereas in Group LD 47.5% were male cases and 52.5% were female cases. In study done by Dhanashree PJ et al [18], there were 16 males (53.33%) and 14 females (46.67%) in the L group. In the LD group, the males were 19 (63.33%), and the females were 11 (36.67%).

ASA Grade

In the present study in Group L 40% cases were seen with ASA Grade I and 60% cases with ASA Grade II whereas in Group LD 45% cases were seen with ASA Grade I and 55% cases with ASA Grade II.

Heart Rate

In the present study in Group L at 30 mins 82.50 mean HR was observed where in Group LD 83.13 mean HR was observed. At 2 hours in Group L 81.40 mean HR was observed where in Group LD 74.93 mean HR was observed. At 4 hours in Group L 80.48 mean HR was observed where in Group LD 72.38 mean HR was observed. At 6 hours in Group L 78.08 mean HR was observed where in group LD 70.90 mean HR was observed. At 8 hours in Group L 79.58 mean HR was observed where in Group LD 68.05 mean HR was observed. At 12 hours in Group L 81.25 mean HR was observed where in Group LD 79.43 mean HR was observed. At 16 hours in Group L 81.55 mean HR was observed where in Group LD 70.23 mean HR was observed. At 24 hours in Group L 79.48 mean HR was observed where in Group LD 76.65 mean HR was observed. At any interval statistically no significant difference was observed in HR between both groups.

Mean Arterial pressure

In the present study in Group L at 30 mins 89.60 mean MAP was observed where in Group LD 88.48 mean MAP was observed. At 1 hour in Group L 87.38 mean MAP was observed where in Group LD 86.90 mean MAP was observed. At 2 hours in Group L 84.08 mean MAP was observed where in Group LD 76.88 mean MAP was observed. At 4 hours in Group L 82.2 mean MAP was observed where in Group LD 74.85 mean MAP was observed. At 6 hours in Group L 78.10 mean MAP was observed where in group LD 72.13 mean MAP was observed. At 8 hours in Group L 77.35 mean MAP was observed where in Group LD 70.28 mean MAP was observed. At 12 hours in Group L 79.10 mean MAP was observed where in Group LD 71.15 mean MAP was observed. At 16 hours in Group L 82.83 mean MAP was observed where in Group LD 74.43 mean MAP was observed. At 24 hours in Group L 84.88 mean MAP was observed where in Group LD 78.10 mean MAP was observed. At any interval statistically no significant difference was observed in MAP between both groups.

VAS

In the present study in Group L at 30 mins 1.1 mean VAS was observed where in Group LD 0.85 mean VAS was observed. At 1 hour in Group L 1.4 mean VAS was observed where in Group LD 0.9 mean VAS was observed. At 2 hours in Group L 1.6 mean VAS was observed where in Group LD 1.4 mean VAS was observed. At 4 hours in Group L 2.6 mean VAS was observed where in Group LD 1.8 mean VAS was observed. At 6 hours in Group L 4.8 mean VAS was observed where in group LD 2.8 mean VAS was observed. At 8 hours in Group L 6.7 mean VAS was observed where in Group LD 3.5 mean VAS was observed. At 12 hours in Group L 7.8 mean VAS was observed where in Group LD 4.8 mean VAS was observed. At 16 hours in Group L 8.2 mean VAS was observed where in Group LD 6.6 mean VAS was observed. At 24 hours in Group L 9.80 mean VAS was observed where in Group LD 8.45 mean VAS was observed. At 30 mins, 1 hour, 12 hours, 16 hours and 24 hours statistically significant difference was observed in VAS between both groups.

In study done by Dhanashree PJ et al [18], no statistically significant difference in VAS at the 1st h and 2nd h, with a P=1.00 and 1.00 between the groups. However, there is a statistically significant difference in VAS at the 4th h, 6th h, 8th h, and 12th h, with a P=0.001, 0.001, 0.001, and 0.001, respectively.

In study conducted by Mohanty S et al [19], At different time intervals, VAS scores were significantly lower in the Group LD compared to the group L. (p < 0.05)

Time for first analgesia-

In the present study in Group L 6.63 mean time for analgesia was observed where in Group LD 12.85 mean time for first analgesia was observed. Statistically significant difference was observed in time for first analgesia between both groups.

In study conducted by Mohanty S et al [19], time to first analgesic request was 3.29 ± 0.51hrs in levobupivacaine group and 6.72 ± 0.49 hrs in levobupivacaine dexmedetomidine group.

Adverse side effects

In the present study in Group L 45% cases were observed with nausea, 25% cases with vomiting and 20% cases were observed with headache whereas in Group LD 5% each case were observed with nausea and vomiting side effects respectively. Statistically significant association was observed between the adverse side effects between both groups.

Ultrasound guided Transversus Abdominis Plane (TAP) block is a very successful method of postoperative analgesia in patients undergoing abdominal and pelvic surgeries. When compared to ordinary levobupivacaine, the addition of dexmeditomedine to levobupivacaine in TAP block prolonged the duration of analgesia with negligible side effects and caused no appreciable alterations in haemodynamic parameters or problems. Analgesia with ultrasound guided TAP block is dependable and efficient, and it was simpler to execute.

After all the data were evaluated, there was no significant difference seen in the demographic profile, length of operation, or haemodynamic parameters between the two groups. The levobupivacaine plus dexmeditomedine group experienced an average duration of analgesia of 12 hours, while the levobupivacaine group experienced an average duration of 6 hours. Notably, the difference in analgesia duration between the two groups was statistically significant. Bradycardia, post-operative nausea, vomiting hypotension, and other problems were not statistically significant and occurred in similar proportions in both groups. Dexmeditomedine and levobupivacaine were combined to provide an ultrasound- guided Transversus Abdominis Plane Block that resulted in an extended period of analgesia without causing any notable adverse effects.

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