It is well established fact that laparoscopic cholecystectomy causes less postoperative pain as compared to open cholecystectomy.

However it is not completely painless. The accurate assessment of pain is difficult because of its individual threshold, subjectivity and difficulty in measurement. Various methods of analgesia including NSAIDS and opioids have been tried to reduce postoperative pain. However the prevention of pain with long acting local anaesthetic infiltration at port site achieves peripheral blockage of painful stimuli, which is more advantageous than treating pain after it occurs. It is postulated that this reduces postoperative pain and analgesic requirements. Periportal infiltration of bupivacaine and levobupivacaine has been used for relief of postoperative pain in laparoscopic cholecystectomy (Alexander DJ, Ngoi SS et al, 1996 and Louizos AA, Hadzilia SJ et al, 2005). Only few comparative studies are available for assessing early postoperative pain following laparoscopic cholecystectomy. Therefore, it has been proposed to do comparative clinical evaluation of early postoperative pain with or without port site infiltration with ropivacaine during laparoscopic cholecystectomy.

Port site infiltration with long acting local anaesthetics has been used as an adjuvant for the relief of postoperative pain in laparoscopic cholecystectomy. When administered before surgery, this technique decreases anaesthetic and analgesic requirement during surgery as well as reduces the need for opioids postoperatively. Periportal infiltration of Bupivacaine and levobupivacaine has been used for relief of postoperative pain in laparoscopic cholecystectomy (Alexander DJ, Ngoi SS et al 1996). These agents are known to produce cardiac and nervous toxicities if inadvertently injected intravenously (especially bupivacaine). Therefore, in our study we will be using ropivacaine which is least cardiotoxic. It belongs to amide group, and is a pure S-enatiomer, chemically described as S-(-)-1-propyl-2, 6- pipecoloxylidide hydrochloride monohydrate with molecular formula of C17H28N2O.HCL.H20. It has both anaesthetic and analgesic effects. It produces surgical anaesthesia at high doses and analgesia (sensory block with limited and non-progressive motor block) at lower doses. Ropivacaine causes reversible blockade of impulse propagation along nerve fibers by preventing the inward movement of sodium ions through the cell membrane. The plasma concentration depends upon the dose, the route of administration, and the vascularity of the site of injection. Ropivacaine follows linear pharmacokinetics and the Cmax is proportional to the dose. Time of onset of action is 4mins and effect lasts for 8-10hrs. Half life of ropivacaine is 4.2hrs with clearance of o.44L/min. 94% of plasma ropivacaine is bound to alpha-1
2

acid glycoprotein. Ropivacaine is extensively metabolised in the liver, mainly by aromatic hydroxylation. The major metabolite is 3-hydroxy-ropivacaine, about 37% of which is excreted in the urine, mainly conjugated. Dose of ropivacaine for local infiltration is 2-5mg/kg body weight. It is to be stored at a temp. Of 20-25 degree Celsius. Rare adverse effects associated with the use of ropivacaine include allergic reactions, cardiovascular and central nervous system toxicities after systemic exposure to excessive quantities. Ropivacaine is available in 2(0.2%), 5(0.5%), 7.5(0.75%), 10(1%) mg/ml concentrations.

Nicolau A.E, Grecu I et al. (1990) conducted randomised double blind controlled trial comprising 60 patients assigned into four groups and concluded that ropivacaine shows significant favourable effects on postoperative pain after laparoscopic cholecystectomy when using both parietal and intraperitoneal instillation. Bisgaard T, Klarskov B, Kristiansan VB, et al (1999) They conducted a randomized trial comprising of 58 patients who received a total of 286mg(66ml) ropivacaine or 66ml of saline via periportal and intraportal infiltration. During the first 3 postoperative hrs, the use of morphine and antiemetic was registered, and pain and nausea were rated hourly. Daily pain intensity, pain localization, and supplemental analgesic consumption were registered the first postoperative week. Ropivacaine reduced overall pain the first 24 hrs and incisional pain for the first 3 postoperative hrs. During first 3 postoperative hrs, morphine requirements were lower, and nausea was reduced in the ropivacaine group. They concluded that a combination of incisional and intra-abdominal local anaesthetic treatment reduced incisional pain and incisional infiltration of local anaesthetic is recommended in patients undergoing laparoscopic cholecystectomy.

Pavlidis T.E, Atmatzidis K.S,et al. (2003) conducted prospective randomised study comprising 190 patients. The control group comprised 75 cases of laparoscopic cholecystectomy and 20 cases of laparoscopic inguinal
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hernia repair without use of local anaesthesia, only saline was used. The study group comprised 75 cases of laparoscopic cholecystectomy and 20 cases of laparoscopic inguinal hernia repair with preincisional periportal infiltration with 20ml of ropivacaine (10mg/ml). They used visual analogue scale for assessment of postoperative pain. No analgesia was required in 41% of laparoscopic cholecystectomy cases and 85% of laparoscopic inguinal hernia repair cases in study group. In control group in 20% of laparoscopic cholecystectomy cases and 44% of laparoscopic inguinal hernia repair cases no analgesia was required. They concluded wound infiltration with ropivacaine provide satisfactory postoperative analgesia and reducing need for opioids. Memedov C, Mentes O, Simsek A, et al (2008) they conducted a prospective randomized study over 45 patients. The patients were randomized into 3 groups to receive either a total of 150mg(80ml) ropivacaine or a mixture of 400mg(20ml) prilocaine(80ml) or placebo (80ml saline).80ml were injected into gallbladder, right and left sub diaphragmatic areas and onto visceral peritoneum, and 20ml, 5ml each, were injected around entry of 4 port sites. Visual analogue scale was used for postoperative pain assessment at 2, 4, 8, 12, 18, 24hrs after the surgery. They concluded that multiregional intraperitoneal instillation and port site infiltration of ropivacaine, a long acting local anaesthetic, after laparoscopic cholecystectomy is a non-invasive, safe and simple technique that reduces pain and postoperative tramadol consumption. The same effect was not observed with prilocaine administration.
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George P.G, Nicolas Z et al. (2008) conducted randomised double blind controlled trial comprising 120 patients assigned in 6 groups and concluded preincisional local infiltration and intraperitoneal infusion of ropivacaine at the beginning of laparoscopic cholecystectomy is safe and valid method for reducing pain after laparoscopic cholecystectomy. Liu Y.Y, Yeh C.N, Lee H.L et al. (2009) randomised 72 patients into 2 groups. One group received port site ropivacaine at the end of laparoscopic cholecystectomy and the other group received normal saline. Visual analogue scale was used to assess pain score. They concluded port site pain and requirement of opioids was lower in study group with shorter hospital stay as compared to control group. Tsimoyiannis EC, Tsimogiannis KE, Farantos C, et al (2010) conducted a randomized controlled trial involving 40 patients who were randomly assigned into 2 groups. In group A, 4 port classic laparoscopic cholecystectomy was performed. In group B, single incision laparoscopic cholecystectomy was performed. In all patients, pre-incisional local infiltration of ropivacaine around the trocar wound was performed. Postoperative pain was assessed by visual analogue scale. They observed significant lower pain scores in single incision laparoscopic cholecystectomy group and also less requirements for analgesics. Cha SM, Kang H, Baek CW, et al (2011) they conducted a randomized double blind control trial to evaluate the effect of peritrocal, intraperitoneal,
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combined peritrocal-intraperitoneal ropivacaine on the parietal, visceral and shoulder tip pain after laparoscopic cholecystectomy. They randomly assigned 80 patients into 4 groups. Group A received peritrocal and intraperitoneal saline. Group B received peritrocal saline and intraperitoneal ropivacaine. Group C received peritrocal ropivacaine and intraperitoneal saline. Group D received peritrocal and intraperitoneal ropivacaine. Postoperative pain was assessed by visual analogue scale at 2, 4, 8, 12, 24 and 48 hrs following surgery. They concluded that peritrocal infiltration of ropivacaine significantly decreases parietal pain and intraperitoneal instillation of ropivacaine significantly decreases the visceral and shoulder pain. El-labban GM, Hokkam EN, El-labban MA. et al. (2011) they conducted a randomized controlled study involving 189 patients who underwent laparoscopic cholecystectomy. They divided patients into 3 groups. Group I who didnt received either intraperitoneal or intraincisional levobupivacaine. Group II received local infiltration of 0.25% levobupivacaine and group III received 20ml solution of 0.25% levobupivacaine intraperitoneally.

Postoperative pain was recorded for first 24hrs using visual analogue scale. They concluded intraincisional infiltration of levobupivacaine is more effective than intraperitoneal route in controlling post operative pain and reduced need for analgesics.

1. To evaluate and compare early postoperative pain following laparoscopic cholecystectomy with or without port site local anaesthetic infiltration. 2. To compare the clinical outcome in these two groups of patients.

All patients who will be subjected to laparoscopic cholecystectomy will be included in the study which shall be conducted in post graduate Department of surgery, Government Medical College, Jammu from December 2011 to December 2012. Patients will be divided into two groups after matching age group, Body mass index and co morbid conditions. Group I- Patients in group I will be subjected to local anaesthesia with 0.75% ropivacaine before making skin incision. Group II- Patients without port site infiltration of local anaesthetic. SENSITIVITY TEST FOR ROPIVACAINE. Patients in group I will be subjected to hypersensitivity test one day before surgery, 0.1ml of 0.75% ropivacaine will be injected intradermally(using insulin syringe) into flexor aspect of left forearm. An observation will be made at the injected site after 20 min. Development of erythema or wheel of >5mm will be considered positive and patient will be excluded from the study. EXCLUSION CRITERIA 1. Patients with hypersensitivity to ropivacaine. 2. Children < 14yrs of age. 3. Pregnancy. 4. Patients taking theophylline, verapamil and fluvoxamine (Drug interactions).
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MATERIAL 1. Local anaesthetic-0.75% ropivacaine. Dose 2-5mg/kg body weight. 2. Scale of 10cm for assessment of pain. 3. Insulin syringe for sensitivity test. Patients will be examined as per the proforma attached. Routine pre-anaesthetic check up of every patient will be performed. All patients will be given premedication including injection Diclofenac 75 mg intramuscular, injection Glycopyrrolate, 3rd generation cephalosporin. Patient will be administered general anaesthesia. METHOD OF INFILTRATION Before making skin incision for introducing port, the proposed port site will be infiltrated throughout all layers with 20ml of 0.75% ropivacaine (maximum of 40 ml). Before injecting ropivacaine it will be made sure that it will not enter any vessel and during surgery monitoring will be done for any side effects like hypotension. Post operatively pain will be assessed in first 24hrs with the help of visual analogue scale at 3rd, 6th, 12th and 24hrs after surgery. Pain will be assessed at rest, on coughing and on walking. Post operative pain assessment will include pain at port site, shoulder pain or pain at any other site. If visual analogue scale will be above 3 at rest, an intramuscular injection of diclofenac 75mg will be given. If pain still persists injection nalbuphine 10mg will be
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administered slowly intravenously. These injections will be repeated at in minimum interval of 8hrs if required. The post operative analgesia requirement will be assessed in both the groups and the difference will be assessed statistically at 3rd, 6th, 12th and 24hrs following laparoscopic cholecystectomy.

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1. Alexander DJ, Ngoi SS, Lee L. et al. Randomized trial of periportal bupivacaine for pain relief after laparoscopic cholecystectomy. Br J Surg 1996;83:1123-5. 2. Bilge O, Tekant Y, Yavru A. et al. The effect of post incisional injection of bupivacaine on post-operative pain in laparoscopic cholecystectomy: a prospective randomized study. Ulusal Cerrahl Dergisi (Turkish J Surg) 1997;13:349-53. 3. Bisgaard T, Klarskov B, Kristiansan VB, et al. Multiregional local anaesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blind, placebo-controlled study. Anesth Analg 1999; 89: 1017-24. 4. Casati A, Putzu M. Bupivacaine, levobupivacaine and ropivacavine: are they clinically different. Best practice clinical anaesthesia. 5. Cha SM, Kang H, BaekCW, et al. Peritrocal and intraperitoneal ropivacaine for laparoscopic cholecystectomy. A prospective randomized double-blind control trial. J Surg Res 2011; 21658722. 6. El-labban GM, Hokkam EN, El-labban MA. et al. Intraincisional vs. intraperitoneal infiltration of local anaesthetic for controlling early postlaparoscopic cholecystectomy pain. J Min Access Surg2011;7:173-7. 7. Forani M, Miglietta C, Di Gioia S, Garrone C, Morino M. The use of intraoperative topical bupivacaine in the control of post operative pain folloeing laparoscopic cholecystectomy. Minerva Chir. 1996;51:881-885.
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8. Goerge P.G, Nicolaos Z, Konstantinos N. et al. Preincisional and intraperitoneal ropivacaine plus normal saline infusion for post operative pain relief after laparoscopic cholecystectomy- A randomized double blind control trial. Surg Endsc 2008;22:2036-2045. 9. Kucuk C, Kadiogullari N, Canoler O, Savli S. A placebo controlled comparison of bupivacaine and ropivacaine instillation for preventing postoperative pain after laparoscopic cholecystectomy. Surg Today 2007;37:396-400. 10. Labille T, Mazoit JX, Paqueron X, Franco D, Benhamou D. The clinical efficacy and pharmacokinetics of intraperitoneal ropivacaine for

laparoscopic cholecystectomy. Anesth Analg 2002;94: 100-5. 11. Lee IO, Kim SH, Kong MH. et al. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth. 2001;48:545-550. 12. Liu Y.Y, Yeh C.N, LeeH.L. et al. Local anaesthesia with ropivacaine for patients undergoing laparoscopic cholecystectomy. World J Gastroenterol 2009 May 21;15(19):2376-2380. 13. Louizos AA, Hadzilia SJ. et al. A placebo controlled double blind randomized trial of preincisional infiltration and intraperitoneal instillation of levobupivacaine 0.25%. Surg Endosc2005;19:1503-6.

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14. Maharjan SK, Shrestha S. Intraperitoneal and periportal injection of bupivacaine for pain after laparoscopic cholecystectomy. Kathmandu University Medical Journal 2009;7:50-53. 15. Memedov C, Mentes O, Simsek A, et al. [Multiregional local anaesthetic administration for the prevention of postoperative pain after laparoscopic cholecystectomy: placebo controlled comparison of ropivacaine and prilocaine]. Gulhane Med J 2008; 50(2): 84-90. 16. Nicolau A.E, Grecu I, Micu B. Multimodal analgesia in elective laparoscopic cholecystectomy- A double blind randomized control trial. Chirurgia 1990;103(5):547-551. 17. Papagiannopoulou P, Argiriadou H. et al. Preincisional local infiltration of levobupivacaine vs ropivacaine for pain control after laparoscopic cholecystectomy. Surg Endosc 2003;17:1961-4. 18. Pavlidis T.E, Atmatzidis K.S, Papaziogas B.T, Makris J.G et al. The effect of preincisional periportal infiltration with ropivacaine in pain relief after laparoscopic procedures. JSLS 2003;7(4):305-310. 19. Sarac AM, Aktan AO, Baykan N, Yegen C, Yalin R. The effect and timing of local anaesthesia in laparoscopic cholecystectomy. Surg Laparosc Endosc. 1996;6:362-366. 20. Tsimoyiannis EC,Tsimogiannis KE, Farantos C, et al. Different pain scores in single transumblical incision laparoscopic cholecystectomy versus

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classic laparoscopic cholecystectomy: a randomized controlled trail. Surg Endosc. 2010; 24(8): 1842-8. 21. Ure BM, Troidl H, Spangenberger W et al. Preincisional local anaesthesia with bupivacaine and pain after laparoscopic cholecystectomy. Surg Endosc 1993;7:482-88.

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Name of patient Age Sex MRD No. Date of admission Date of discharge Date of surgery HISTORY Chief complaints Past history Personal history Family history Drug history EXAMINATION Pulse Blood pressure Pallor Icterus Cyanosis Oedema

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Respiratory system

Cardiovascular system

Abdomen

INVESTIGATIONS ABO, Rh grouping. Hb, BT, CT, TLC, DLC, Platelet counts. PTI. Renal function tests. Liver function tests. Blood sugar. X-ray chest-PA view. USG abdomen. ECG all leads.

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Assessment of early postoperative pain

3 hrs-

6 hrs-

12 hrs-

24 hrs-

Group I

Group II

No. of doses of inj. diclofenac required in 24 hrs

No. of doses of inj. nalbuphine required in 24hrs

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