A study to compare the effect of postoperative analgesia between intraperitoneal instillation of ropivacaine and bupivacaine in laparoscopic surgeries

 

 

Abstract              Background: Laparoscopic techniques have revolutionized the field of surgery with benefits that include decreased postoperative pain, earlier return to normal activities following surgery, and fewer postoperative complications. Management of postoperative pain relievers suffering and leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. Objectives: To measure Postoperative Analgesia of Intraperitoneal Instillation of Ropivacaine and Bupivacaine in Laparoscopic Surgeries by using time to first request of analgesia. Methodology: The present study was conducted at Sri Manakula Vinayagar Medical College and Hospital, Pondicherry in the Department of Anaesthesia. The double blinded randomized experimental study was conducted from October 2017 to May 2019.The sample size of 50 study subjects was selected using the mean pain score at 3.6 with 80% power and 95% confidence interval. In each of the group 25 study subjects were allotted based on randomization. All patients were instilled with 30 ml of solution in a standardized manner by the operating surgeon under vision before removal of trocar at the end of the surgical procedure. Group R received 30 ml (0.2%) ropivacaine and group B received 30 ml (0.25%) bupivacaine. The drugs were prepared and given to the investigator who was blind to the identity of drugs. Results: Both the study groups were comparable in terms of age, no significant difference was observed between the groups No significant association was observed between pain score and the study groups at 60 and 120 mins . Significant association was seen at 8,12 and 24 hrs .Conclusion : Pain scores were not significantly different between the study groups till 4 hours, however, higher pain scores were noted in Bupivacaine group thereafter. Also, this difference in pain scores between the study groups after 8 hours was found to be statistically significant.

KEYWORDS: Pain, Vas Score ,Bupivacaine, Laprotomy ,Intraperitonieal

 

INTRODUCTION

Laparoscopic techniques have revolutionized the field of surgery with benefits that include decreased postoperative pain, earlier return to normal activities following surgery, and fewer postoperative complications (eg, wound infection, hernia). However, unique complications are associated with gaining access to the abdomen for laparoscopic surgery. Inadvertent bowel injury or major vascular injury is uncommon, but both are potentially life-threatening complications that are most likely to occur during initial access.^1,2,3

In abdominal surgeries, the cause of pain is

1. Somatic

2. Visceral.

Somatic pain is due to skin incision and the visceral pain is due to handling of the intestine and peritoneal inflammation. During open surgeries, both somatic and visceral pain will be present which may not be tolerable to a patient without adequate analgesia. In Laparoscopic surgeries somatic pain is very less due to a small skin incision. But visceral pain is more prominent due to visceral nociceptor stimulation. Visceral Pain may occur due to rapid distension of peritoneum, intraperitoneal inflammation, traction of nerves and vessels, diaphragmatic irritation (shoulder tip pain). Post laparoscopic pain can be minimized by following ways: - creating the pneumoperitoneum slowly, aspiration of gas under the diaphragm which lets out the residual CO2, keeping gas drain, using low pressure and heated gas, using nitrous oxide pneumoperitoneum, instillation of local anesthetics under the diaphragm, rectus sheath block, surgery under subarachnoid block, peri- operative NSAID’S and opioids. Intra peritoneal local anaesthesia is a simple, cheap and safe method of providing post-operative analgesia.^4,5 Management of postoperative pain relievers suffering and leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction.^9-11 Pain control regimens should not be standardized; rather, they are tailored to the needs of the individual patient, taking into account medical, psychological, and physical condition; age; level of fear or anxiety; surgical procedure; personal preference; and response to agents given. Inflammation from tissue trauma (i.e., surgical incision, dissection, burns) or direct nerve injury (i.e., nerve transaction, stretching, or compression) is the main factor behind post-operative pain. The patient feels pain through the afferent pain pathway = which can be altered by numerous pharmacologic mediators.⁶ Intraperitoneal local anesthetics acts by blocking the visceral nociceptors, thereby, decreasing the visceral pain in laparoscopic surgeries. It also has anti-inflammatory action and prevents peritonitis and bowel adhesion. Visceral nociceptors will be stimulated by handling of the viscera and the peritoneum causing inflammation and pain.

 

Objectives:

To measure Postoperative Analgesia of Intraperitoneal Instillation of Ropivacaine and Bupivacaine in Laparoscopic Surgeries by using time to first request of analgesia.

 

MATERIALS AND METHODS

The present study was conducted at Sri Manakula Vinayagar Medical College and Hospital, Pondicherry in the Department of Anaesthesia. The double blinded randomized experimental study was conducted from October 2017 to May 2019.

The sample size of 50 study subjects was selected using the mean pain score at 3.6 with 80% power and 95% confidence interval. In each of the group 25 study subjects were allotted based on randomization.

Inclusion Criteria: The subjects within the Age group of 18-60 years and belonging to ASA I and II Category undergoing Laparoscopic surgery

Exclusion Criteria: Subjects suffering from Renal or any systemic Illness and those who are allergic to the drugs being examined and who didn’t give consent.

All patients were instilled with 30 ml of solution in a standardized manner by the operating surgeon under vision before removal of trocar at the end of the surgical procedure. Group R received 30 ml (0.2%) ropivacaine and group B received 30 ml (0.25%) bupivacaine. The drugs were prepared and given to the investigator who was blind to the identity of drugs.

The quality of analgesia was assessed by visual analogue scale (VAS). Time to first request of analgesia, total dose of analgesic in first 24 hours and adverse effects were also noted. All patients were explained about the anaesthesia technique andwritten informed consent taken. Patients were kept NPO for 8hours prior to surgery. Patients were shifted to the post-operative recovery room when they were breathing spontaneously and following verbal command with stable vital parameters. Postoperative pain was assessed using numeric VAS 0 - 10. When the VAS pain score was equal or more than 4, the patients were given inj. diclofenac sodium as a rescue analgesic in the dose of 2 mg/kg intravenously slowly. The severity of PONV was graded on a four-point ordinal scale (0- no nausea or vomiting; 1-mild nausea; 2- moderate nausea; and 3- severe nausea with vomiting). Rescue antiemetic ondansetron 4 mg intravenously was given to all patients with PONV of grade ≥2. Means and proportions were calculated for continuous and categorical data respectively. Difference in proportions were tested using chi square test. Tests of normality were carried out for continuous variables and Mann Whitney U test was carried out to test statistical difference in means between the study groups. A p value <0.05 was considered statistically significant. Data entry was done using MS Excel 2013 and data analysis was carried out using SPSS version 23.0

RESULTS

A total of 25 study subjects were selected and enrolled in each of the group.

 

Table 1: Distribution of study groups based on age (n = 50)

Both the study groups were comparable in terms of age, no significant difference was observed between the groups (p value -0.476)

Table 2: Distribution of study groups based on pain score at 60 mines (n = 50)

No significant association was observed between pain score and the study groups at 60 mines (p value -0.505)

 

Table 3: Distribution of study groups based on pain score at 120 mins (n = 50)

No significant association was observed between pain score at 2 hours and the study groups (p value -0.401).

 

Table 4: Distribution of study groups based on pain score at 8 Hrs. (n = 50)

Significantly higher pain scores are observed in Bupivacaine group as compared to Ropivacaine group at 8 hours (p value -0.027).

Table 5: Distribution of study groups based on pain score at 12 Hrs. (n = 50)

Significantly higher pain scores are observed in Bupivacaine group as compared to Ropivacaine group at 12 hours (p value -0.006)

Table 6: Distribution of study groups based on pain score at 24 Hrs. (n = 50)

Significantly higher pain scores are observed in Bupivacaine group as compared to Ropivacaine group at 24 hours (p value -0.044).

 

Table 7: Distribution of study groups based on PONV (n = 50)

Presence of PONV was noted only in one patient in Ropivacaine group (p value – 1.0).

 

 

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