INTRAPERITONEAL INSTILLATION OF BUPIVACAINE AND
GLYCEMIC LEVELS IN LAPROSCOPIC SURGERIES: A DOUBLE
BLIND, PLACEBO-CONTROLLED TRIAL
D. Suresh Chander1, M. Bhanu Lakshmi2, G. Venkateshwarlu3, Fathima Aafreen4
HOW TO CITE THIS ARTICLE:
D. Suresh Chander, M. Bhanu Lakshmi, G. Venkateshwarlu, Fathima Aafreen. “Intraperitoneal Instillation of Bupivacaine and Glycemic Levels in Laproscopic Surgeries: A Double Blind, Placebo-Controlled Trial”. Journal of Evidence based Medicine and Healthcare; Volume 2, Issue 38, September 21, 2015;
Page: 6041-6045, DOI: 10.18410/jebmh/2015/833
ABSTRACT: BACKGROUND: Surgical stress is associated with hormonal changes. Hyperglycemia is an easily measurable factor to quantify stress. Intraoperative stress can be due to pain or surgical manipulation. We made an attempt to see the glycemic response in laparoscopic patients by intraperitoneal instillation of bupivacaine vs placebo. OBJECTIVES: To observe the response of intraperitoneal instillation of Bupivacaine vs placebo on glycemic levels.
PATIENTS AND METHODS: A prospective randomized double blind, placebo-controlled study was conducted in the department of Anaesthesiology, Gandhi Hospital, Secunderabad. Fifty patients were randomly selected to be enrolled in this study who were scheduled for laproscopic surgery. All patients were of ASA I- II physical status. Study group consisted of 25 patients receiving intraperitoneal bupivacaine 2 mg/kg (Group B) and the control group consisted of 25 patients receiving 20 ml of normal saline as placebo (Group C). Blood sugar levels were measured at baseline and at interval of 30 min and 90 min after incision. Mean blood pressure and pulse rate were recorded at baseline and and every 15 min from incision to 90 min. RESULTS: There is no significant difference in the glycemic levels in both groups. CONCLUSION: Stress during laproscopic cholecystectomy and appendicectomy may not be high enough to cause glycemic derangement. However, the study group is small and needs further studies to substantiate this.
KEYWORDS: Stress, Surgery, Intraperitoneal instillation of drugs, Blood sugar levels, Bupivacaine.
INTRODUCTION: The stress response is the name given to the hormonal and metabolic changes which follow injury or trauma. In the pancreas, glucagon is released and insulin secretion may be diminished. The overall metabolic effect of the hormonal changes is increased catabolism.1 In addition, peripheral insulin resistance develops perioperatively. Plasma glucagon
concentrations increase transiently after major surgery, but this does not make a major contribution to the hyperglycaemic response.
PATIENTS AND METHODS: We conducted a prospective randomized placebo-controlled double blind clinical trial at Gandhi hospital. This study was approved by Gandhi hospital ethical committee. After obtaining written consent, we enrolled 50 adult patients undergoing elective laparoscopic surgeries, belonging to ASA grade I –II.
Patients were randomized to two groups - one group to receive intraperitoneal instillation of 0.5% bupivacaine (2mg/kg) and the other group to receive 20 ml normal saline (placebo group). Anaesthetic and surgical techniques were standardized.
Exclusion criteria included patients who are known diabetics, patients with ASA grade III and IV, known allergy to local anaesthetic, laproscopic surgery converted to open surgery, patients who received intraperitoneal wash at the end of surgery and surgery lasting for more than 90 min from the time of incision.
On the day of surgery, a research assistant not involved with patient care confirmed patient eligibility and written consent. An anaesthesia nurse not involved in the study received from research assistant a sealed opaque envelope containing patient allocation and instructions for the solution preparation. The research assistant was not allowed to enter the operating theatre until the study solutions were being prepared to maintain blinding. In case of an emergency possibly related to the study drugs, the nurse was authorized to disclose the contents of the syringe to the anaesthesiologist of the case (Not involved with the study) and to the research assistant. Patients were randomized using a computer-generated randomization list to receive peritoneal instillation of bupivacaine and peritoneal instillation of normal saline (placebo). Bupivacaine or saline was carried to the abdominal cavity through the umbilical port once the intraperitoneal placement was confirmed. Blood sugars and vital signs like pulse rate, mean arterial blood pressure were recorded at baseline. MAP and pulse rate were measured at incision and thereafter every 15 minutes until 90min. Laparoscopic surgery was performed according to the standard surgical and anaesthesia protocols. Pneumoperitoneum was achieved using non humidified non heated CO2 with the intraabdominal pressure maintained around 14 mm Hg.
Patients were pre-medicated with inj. Glyco 0.2mg, Inj.Ondansetron 1mg/kg, Inj. midazolam 1mg, Inj. Tramadol 2mg/kg. General anaesthesia was induced with popofol 2-3mg/kg i.v.and tracheal intubation was facilitated with Inj. Vecuronium 0.1mg/kg. Anaesthesia was maintained with sevoflurane 1% and Inj. Vecuronium. Ventilation was controlled to maintain ETCO2 between 30-40mmHg. At the end of surgery, residual muscle paralysis was reversed with
Inj. Neostigmine 0.05mg/kg and glycopyrrolate 0.004 mg/kg and tracheal extubation was performed when reflexes regained.
RESULTS: Results obtained were statistically analysed. Level of significance in all statistical tests
and comparisons was set at P value ≤0.05. Both the groups were demographically comparable
with respect to age, sex, ASA grading and weight.
Descriptives
Characteristic
Mean 95% Confidence Interval for Mean Std. Deviation Lower Bound Upper Bound
Place bo
Bupivac aine
Place bo
Bupivac aine
Place bo
Bupivac aine
Place bo
Bupivac aine Age of the
patient 36.5 32.3 30.1 26.8 43.0 37.8 15.6 13.3 Weight of the
patient 59.9 54.3 55.0 50.3 64.8 58.3 11.8 9.7
ASA Grading 1.2 1.1 - - - - 0.41 0.27
Mean
BP@baseline 97.4 92.7 92.2 88.0 102.6 97.5 12.6 11.5 Mean
BP@incision 94.0 93.2 89.4 87.5 98.7 98.8 11.3 13.7 Mean
BP@15min 107.6 106.7 102.5 103.4 112.8 109.9 12.6 7.9 Mean
BP@30min 102.2 101.8 99.0 96.8 105.4 106.9 7.7 12.2 Mean
BP@45min 103.1 98.5 99.6 93.6 106.7 103.4 8.6 11.8 Mean
BP@60min 100.4 98.7 94.6 93.9 106.1 103.5 14.0 11.7 Mean
BP@75min 98.5 99.7 92.9 95.7 104.0 103.8 13.4 9.8 Mean
BP@90min 97.4 98.0 92.1 94.1 102.6 102.0 12.8 9.6
PR@baseline 97.8 99.5 89.0 92.1 106.6 106.8 21.3 17.8
PR@incision 95.5 101.4 90.2 94.0 100.9 108.7 12.9 17.9
PR@15min 98.5 103.4 94.3 97.3 102.6 109.4 10.0 14.7 PR@30min 99.5 101.2 95.2 94.3 103.8 108.2 10.4 16.8 PR@45min 97.4 103.6 92.4 96.2 102.4 111.0 12.1 18.0 PR@60min 97.0 100.4 91.8 92.6 102.2 108.3 12.5 18.9 PR@75min 93.8 99.4 87.0 92.1 100.6 106.7 16.5 17.7 PR@90min 93.2 96.2 86.9 89.8 99.6 102.6 15.4 15.4 GRBS@baseline 98.3 96.7 90.8 89.9 105.7 103.4 18.1 16.3 GRBS@30min 109.8 106.0 102.2 97.7 117.3 114.3 18.3 20.1 GRBS@90min 117.7 118.8 107.9 109.4 127.5 128.3 23.8 22.9
Group GRBS fluctuations >20% from baseline
GRBS fluctuations
<20% from baseline Total
C 7 18 25
B 9 16 25
Total 16 34 50
GRBS @ 30 min -
P =0.84. Not significant relationship.
Group GRBS fluctuations >20% from baseline
GRBS fluctuations
<20% from baseline Total
C 13 12 25
B 13 12 25
Total 26 24 50
GRBS @ 90 min -
P =0.94. Not significant relationship
DISCUSSION: When the body is under stress, the adrenal glands trigger the release of glucose stored in various organs, which often leads to elevated levels of glucose in the bloodstream. In this study we compared the serum glucose levels after intraperitoneal instillation of bupivacaine in one group and normal saline in the other group in view of stress response after laparoscopic surgeries and found that there is no significant difference in rise of serum glucose levels in normal saline group and bupivacaine group (p value insignificant). Blood sugar levels fluctuate depending on the type and duration of stress the patient is subjected.
Surgical pain and manipulation of tissue intraoperatively can induce stress. Visceral component of pain arises when manipulating the tissue. Laproscopic surgeries minimise this tissue manipulation compared to open surgeries.2 Therefore, the stress induced by short
laproscopic procedures may be inadequate to significantly raise the blood sugar levels. This may hold good for surgeries which do not require much tissue manipulation, like in our study which included only laproscopic appendicectomy and laproscopic cholecystectomy. One more point to note is that these are short duration surgeries which lasted for 30 -90 min. However, our study group included a small patient population and it requires further studies to draw a conclusion.
Reviewing the literature, showed some studies on catecholamine release response during laproscopic surgery. Wallin G et al studied the influence of intraperitoneal instillation of bupivacaine and concluded that single administration of a local anesthetic intraperitoneally does not reduce pain or the sympathoadrenal response to upper abdominal surgery.3 Joris J et al
ovariohysterectomy, by Kim YK et al showed that spraying of intraperitoneal bupivacaine reduced early post-operative pain, significant elevation of catecholamine levels, but no significant differences in serum glucose within each group.5
CONCLUSION: Instillation of bupivacaine intraperitoneally did not have any effect on the blood sugar levels in laproscopic surgeries. As the study was confined to a small patient patient population with defined procedures, this study needs to be applied on large patient population to draw a definitive conclusion.
REFERENCES:
1. Desborough J. P. The stress response to trauma and surgery.Br J Anaesth 2000; 85: 109– 17.
2. Kehlet H. Multimodal approach to control post-operative pathophysiology and rehabilitation.Br J Anaesth 1997; 78: 606-17.
3. Wallin G1, Cassuto J, Högström S, Hedner T. Influence of intraperitoneal anesthesia on pain
and the sympathoadrenal response to abdominal surgery. Acta Anaesthesiol Scand. 1988 Oct; 32(7): 553-8.
4. Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995 Aug; 81(2): 379-84.
5. Kim YK, Lee SS, Suh EH, Lee L, Lee HC, Lee HJ, Yeon SC. Sprayed intraperitoneal bupivacaine reduces early postoperative pain behavior and biochemical stress response after laparoscopic ovariohysterectomy in dogs. Vet J. 2012 Feb; 191(2): 188-92.
4. Post Graduate, Department of
Anesthesiology & Critical Care, Gandhi Medical College, Hyderabad, Telangana, India.
NAME ADDRESS EMAIL ID OF THE CORRESPONDING AUTHOR: Dr. M. Bhanu Lakshmi,
Tulip 26, L & T Serene County, Gachibowli,
Hyderabad-500032.
E-mail: sunmoney17@rediffmail.com
Date of Submission: 31/08/2015. Date of Peer Review: 01/09/2015. Date of Acceptance: 13/09/2015. Date of Publishing: 19/09/2015. AUTHORS:
1. D. Suresh Chander 2. M. Bhanu Lakshmi 3. G. Venkateshwarlu 4. Fathima Aafreen
PARTICULARS OF CONTRIBUTORS: 1. Associate Professor, Department of
Anesthesiology & Critical Care, Gandhi Medical College, Hyderabad, Telangana, India.
2. Assistant Professor, Department of Anesthesiology & Critical Care, Gandhi Medical College, Hyderabad, Telangana, India.
3. Professor, Department of
