| AIMS AND OBJECTIVES AIM: - The aim is to find out whether bupivacaine delivered, after general anaesthesia, bilaterally through transversus abdominis plane (TAP) block in lap cholecystectomy helps in preventing hemodynamic changes while creating pneumoperitoneum. OBJECTIVES:- PRIMARY OBJECTIVE To compare whether bilateral TAP block with 0.25% bupivacaine given in the study group just after induction can alleviate hemodynamic changes in lap cholecystectomy while creating pneumoperitoneum with control group who are receiving normal saline in TAP block. SECONDARY OBJECTIVE To observe analgesia in post laparoscopic cholecystectomy patients using Visual Analogue Scale in both groups.   MATERIALS AND METHODS STUDY DESIGN: - a double blinded prospective randomized study SITE OF STUDY: - Rajendra Institute of Medical Sciences, Ranchi DURATION OF STUDY: - One and a half year from the time of approval by the research and ethics committee METHOD OF RANDOMISATION: - The patient will be divided into two groups by computer generated randomization. Opaque sealed envelopes will be used to conceal the group assignment. GROUP B - this case group will receive general anaesthesia along with 0.25% bupivacaine 20 ml on each side by TAP block technique. GROUP C – this control group will receive general anaesthesia along with normal saline 20 ml on each side by TAP BLOCK technique. SAMPLE SIZE: - 25 cases in each group INCLUSION CRITERIA:- 1. Patient posted for laparoscopic cholecystectomy 2. Age between 18-60 years of both gender. 3. Patient willing to give written informed consent. 4. ASA (American society of anesthesiologist) physical status Ι and II 5.Patient not on any antiplatelet or anticoagulation drug. EXCLUSION CRITERIA:- 1.PATIENT refusal for procedure 2.Age less than 18 and more than 60 years 3.Coagulation disorder 4.Allergy to local anaesthesia 5.Uncontrolled hypertensive patients   METHODOLOGY Written consent from the patient will be taken. Pre anaesthetic check-up will be done a day before surgery including detailed history, thorough physical examination and systemic examination. Routine investigations including complete blood count, routine urine examination, electrocardiogram, serum urea, serum creatinine, random blood sugar and chest radiograph PA view. The patient will be kept nil per oral for 8 hours. In the operation theatre, monitors like pulse oximeter, electrocardiogram leads, non invasive blood pressure and end tidal carbon dioxide will be used throughout the operation. Baseline vitals will be noted. The patient will be preoxygenated for 3 minutes with 100% oxygen. Then pre-medicated with midazolam (0.02 mg/kg) followed by fentanyl (2mcg/kg) Induction will be done with 1% propofol (2mg/kg) and intubated with endotracheal tube after giving atracurium (0.5 mg/kg). Maintenance will be done by oxygen, nitrous oxide and sevoflurane with 1 MAC along with maintenance dose of atracurium. Subjects who will be randomised to GROUP B will receive landmark guided B/L TAP block with 0.25% bupivacaine 20 ml on each side. While Group C will receive B/L TAP block with 20 ml N.S. on each side. The landmark-guided technique applies loss of resistance as the needle is advanced through the fascia layers of external oblique and internal oblique [6]. After locating the triangle of Petit[7] which is bounded by the latissimus dorsi posteriorly, the external oblique anteriorly and iliac crest inferiorly, the TAP is identified using the double-pop loss of resistance technique. The first pop indicates penetration of the fascia of the external oblique muscle, and the second indicates piercing of the fascia of internal oblique and entry of the needle into the TAP[8]. When the tip of needle is placed between internal oblique and transversus abdominis muscle, after negative aspiration of blood to exclude vascular puncture, drug will be injected 20ml of 0.25% bupivacaine on each side. We will wait for 15 minutes after the TAP block before the use of Veress needle or Hasson trocar for establishment of pneumoperitoneum. We will observe heart rate and systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) before creating pneumoperitoneum and after 5, 10, 15, 20, 25 and 30 minutes of creating pneumoperitoneum. Patients of both the groups will be observed after 1, 4, 8 and 12 hours in ward after surgery for pain assessment. Visual Analogue Scale (VAS) will be used to access pain. The time for first rescue analgesia and time for VAS score to be 4 or more will be noted. For rescue analgesia DICLOFENAC (1 mg/kg) will be given intra-muscularly (max dose 150 mg). My study on a patient will end at the time when first rescue analgesia will be given. STATISTICS Data will be summarized as mean and standard deviation for numerical variables and count and percentages for categorical variables. For statistical analysis data were entered into a Microsoft excel spreadsheet and then analyzed by SPSS software. For qualitative data, Chi square test will be used to observe the difference between two proportions for the paired value. For quantitative data, student t-test will be used, and data will be expressed by the mean and standard deviation (SD) of the difference between two means for paired observations. P-value < 0.05 will be considered statistically significant. Sample size is calculated as 24.75 ~ 25 approximately in each group by using the formula: n = 16 pq/d2 where n= sample size per group, P1 = 35% or 0.35, P2= 75% or 0.75 Taking 5% as level of significance and 80% as power of study.
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