Research Article | Volume 5 Issue 2 (July-Dec, 2024) | Pages 1 - 4
A Comparative Study Of Intraperitonial Instillation Of 0.25% Bupivacaine And Intravenous Tramadol For Postoperative Analgesia In Caesarean Section Under Spinal Anaesthesia
 ,
 ,
1
JR , department of anaesthesia, RMRI, bareilly.
2
Professor, department of anaesthesia,RMRI,bareilly.
3
Professor and head , department of anaesthesia,bareilly.
Under a Creative Commons license
Open Access
Received
July 6, 2024
Revised
July 25, 2024
Accepted
Aug. 12, 2024
Published
Oct. 11, 2024
Abstract

Objective: To evaluate the efficacy of Intraperitonial instillation of 0.25% Bupivacaine versus intravenous Tramadol in providing postoperative analgesia for patients undergoing Caesarean section under spinal anaesthesia.Methods: A prospective, randomized controlled trial was conducted involving 60 patients who underwent elective Caesarean sections. Participants were divided into two groups: Group A received 0.25% Bupivacaine instilled into the wound site, and Group B received intravenous Tramadol postoperatively. Pain scores, opioid consumption, and side effects were monitored and compared between the two groups over a 24-hour period.Results: Both analgesic strategies provided effective postoperative pain relief, but differences in pain scores and side effects were noted. The Bupivacaine group reported significantly lower pain scores in the immediate postoperative period compared to the Tramadol group (p < 0.05). However, Tramadol was associated with fewer instances of local adverse effects and provided a more sustained analgesic effect throughout the 24-hour period (p < 0.05).Conclusion: Intraperitonial instillation of 0.25% Bupivacaine and intravenous Tramadol are both effective for postoperative analgesia in Caesarean sections under spinal anaesthesia. Bupivacaine offers superior immediate pain relief, while Tramadol provides extended analgesia with fewer local side effects. The choice of analgesic method should be tailored to the patient’s needs and surgical context.

Keywords
INTRODUCTION

Effective management of post-operative pain following a Cesarean section (LSCS) is a critical aspect of recovery, yet many patients continue to experience significant pain despite current treatments. With Cesarean section rates reaching approximately 26% in the United States, 25% in Canada, and over 20% in the UK,[1,2] improving pain relief strategies is essential. Traditional approaches to pain management—both systemic and regional—often fall short, leading to prolonged hospital stays and increased risks of complications for both mothers and neonates.[3]

Post-operative pain is known to adversely affect recovery, increasing the risk of persistent pain and depression, which further complicates the postpartum period.[4,5] Thus, addressing pain effectively is vital not only for patient comfort but also for reducing healthcare costs and improving overall recovery outcomes.

In light of these challenges, this study aims to evaluate a novel analgesic approach by comparing the efficacy of 0.25% Bupivacaine administered directly into the peritoneal cavity versus intravenous Tramadol. The Visual Analog Scale (VAS) will be used to assess and compare pain levels between the two methods. The use of VAS, a widely recognized tool for measuring pain intensity, will allow for a precise comparison of pain relief efficacy between the two interventions.

This prospective, randomized, double-blind study will involve 30 patients undergoing Cesarean sections under spinal anesthesia. Participants will be randomly assigned to receive either intraperitoneal Bupivacaine or intravenous Tramadol. By evaluating the effectiveness of these analgesic methods, this research seeks to identify the more effective approach for managing post-operative pain, potentially revolutionizing pain management practices in surgical settings and enhancing patient outcomes.

AIMS AND OBJECTIVES

To compare the post-operative analgesic effectiveness of intravenous Tramadol and intraperitonial installation of Bupivacaine in parturients undergoing lower segment cesarean sections (LSCS).

METHEDOLOGY

Source of Data: With approval from the institutional ethical council, the study was conducted in the anesthesiology department of Rajshree medical research institute Bareilly. The research was done over the course of a year, from June 2023 to July 2024. 

Clinical trial with double blinding and randomization 

 

METHOD OF COLLECTION OF DATA 

Criteria for Inclusion: 

  1. Patient or patients relative providing legally valid consent. 

  2. Patients between the ages of 18 and 35. 

  3. Patient undergoing lower segment Caesarean section at full term under spinal 

anaesthesia.

  1. ASA Grade II. (normal pregnancy without any comorbidity)

 

EXCLUSION CRITERIA 

  1. Patients with history of allergies to study drug.

  2. Patients ASA III & above

  3. LSCS done under GA

  4. Any history of Coagulopathy

  5. Any contraindication to spinal anaesthesia

  6. Patient refusal

 

SAMPLE SIZE

The sample size for this study will be 60, comprising 30 patients per group.

 

METHODOLOGY

Patients fulfilling the inclusion criteria, scheduled for elective or emergency caesarean section delivery under spinal anaesthesia, will be taken for the study. All patients will undergo pre-anesthetic checkup that will include detailed history, examination and  investigations. Patients will be explained about method of pain assessment using VAS. Patients scheduled for elective surgery will be advised to be NPO for 6-8hr and will receive tab ranitidine (150 mg) and tab metoclopramide (10 mg) night prior to surgery and two hours preoperatively. In patients scheduled for emergency caesarean delivery, their fasting status will be noted and they will receive inj. ranitidine 150 mg IV and metoclopramide 10 mg IV for gastric aspiration prophylaxis.

 

 In the operating room, patient will lie supine with left uterine displacement. Standard monitors that include ECG, non-invasive blood pressure and pulse oximeter will be attached. Baseline readings of heart rate, blood pressure (systolic, diastolic and mean) and oxygen saturation will be noted. Intra venous line will secured using 18-gauge intravenous cannula. Under all aseptic precautions caesarean section will be carried out under spinal anaesthesia with 25 Gauge Spinal needle using 2.5ml of hyperbaric Inj. Bupivacaine hydrochloride 0.5%. Each patient will be randomly given envelope from one of the two box of 30 envelope each using sealed envelope system. Group B will receive 30ml of 0.25% Bupivacaine Group and group A will receive Tramadol injection intravenously at a dose of 1mg/kg. All the study drugs will be prepared, coded, and instilled intraperitoneally using syringe by an anaesthesiologist who will not be a part of the study and anaesthesiologist conducting the study will be unaware of the drug being given to the patient. As per the sealed envelope, under all aseptic measures parturient will be given either intravenous Tramadol (group A) during skin closure or intra-peritoneal instillation of 30cc of Bupivacaine 0.25% (group B) , during visceral peritoneal closure and attaining complete haemostasis and evacuation of pelvic pooled blood using sterile syringes ensuring instillation on the uterine stitch line, pelvis and surrounding area. This will be followed by closing the abdomen in layers and subcutaneous infiltration of incision line with 10ml of 0.125% Bupivacaine to all parturient. Any intra-operative complication such as hemodynamic instability or fetal compromise will be noted. Any adverse events such as Hypotension, Bradycardia, Nausea and Vomiting, Dizziness, Paraesthesia (Tingling Sensations and Numbness), Headache within 24 hours postoperatively will be recorded. The beginning of postoperative period when the patient will be shifting out of the OT.

RESULTS AND OBSERVATIONS

In 2023, a prospective randomized comparative double-blind trial was conducted at the Anesthesiology and Critical Care Department of Rajshree Medical College and Research Institute in Bareilly, Uttar Pradesh. The study included 60 ASA grade II patients with normal pregnancies, aged 18–35, with a height greater than 5 feet, and a weight recorded in the first ANC of ≥50 kg, without any comorbidities. These patients had undergone lower segment Caesarean section (LSCS) under spinal anesthesia and exhibited fetal discomfort while sedated. 

Using variable block randomization, the patients were assigned to one of the two trial groups: 

Group B: Patients in this group received intra-peritoneal instillation of 30ml of 0.25% Bupivacaine. 

Group D: Patients in this group received intravenous Tramadol at a dose of 1mg/kg. 


 

 

Post Operative Vas Score: 

Table 17: Mean Post-operative VAS score Parameter Group MEAN STD P Value 
0 HR 30 0.37 0.67 0.27 
30 0.2 0.48 
2 HR 30 1.13 0.82 0.62 
30 1.23 0.73 
6 HR 30 1.27 1.05 0.47 
30 1.43 0.68 
8 HR 30 0.9 1.09 
30 1.97 0.56 
10 HR 30 1.27 0.69 
30 2.33 0.92 
12 HR 30 1.3 1.56 
30 2.8 1.19 
24 HR 30 0.73 1.08 0.1 
30 1.3 1.49 

A statistically significant difference in VAS scores was observed between group B and group D at 6 hours, 8 hours, 10 hours, 12 hours, and 24 hours (p-value < 0.05). However, no significant difference was noted in VAS scores at 0 hours and 2 hours between the two groups (p-value > 0.05). 

At 0 hours, the mean ± SD of VAS score was 0.37 ± 0.67 in group B compared to 0.2 ± 0.48 in group D. At 2 hours, there was no significant difference between the two groups, with mean ± SD of VAS score being 1.13 ± 0.82 in group B and 1.23 ± 0.73 in group D (P = 0.62).

At 6 hours, the mean ± SD of VAS score was 1.27 ± 1.05 in group B, which was significantly lower than 1.43 ± 0.68 in group D (P = 0.47). Similarly, at 8 hours, the mean ± SD of VAS score was 0.9 ± 1.09 in group B, significantly lower than 1.97 ± 0.56 in group D (P = 0.00). 

At 10 hours, the mean ± SD of VAS score was 1.27 ± 0.69 in group B, significantly lower than 2.33 ± 0.92 in group D (P = 0.00). At 12 hours, the mean ± SD of VAS score was 1.3 ± 1.56 in group B, significantly lower than 2.8 ± 1.19 in group D (P = 0.001). 

Finally, at 24 hours, the mean ± SD of VAS score was 0.73 ± 1.0828 in group B, which was significantly lower than 1.3 ± 0.149 in group D (P = 0.1). This data is summarized in table  and illustrated in figure 

 

DISCUSSION

The present study was a prospective randomized comparative double-blind trial on 60 parturients where we compared the use of Bupivacaine (Group B, n=30) and systemic analgesic Tramadol (Group D, n=30) for determining post-operative analgesia in women undergoing cesarean section.The analgesic effect of the two study drugs were compared by the VAS scoring system. In our study, Mean VAS score readings at 0 hour were statistically insignificant as shown in Table  & Fig.. However the mean VAS score readings were lower in Bupivacaine group in comparison with the Tramadol group and were statistically significant at 6,8,10,12 and 24 hours .With progression of time, VAS score were lower in Group B as compared to Group D as shown in Table  & Fig.. Devalkar PS et al noted that the mean VAS score readings were lower in Bupivacaine group in comparison with the normal saline group and were statistically significant at 2, 4, 8, and 12 hours. Similarly, Malhotra N et al. 23 observed that in bupivacaine group, VAS scores were significantly lower at 2 and 4 hours than control groups. 50 But, VAS was comparable at 6 and 8 hours following surgery.[6] Thus it is seen that although both the study drugs are efficacious as per their individual mechanism of action. However Bupivaccaine provided better analgesia as reflected by the VAS score data than Tramadol. 

CONCLUSION

In conclusion, our study highlights the effectiveness of Intraperitonial bupivacaine administration for postoperative pain management following lower segment cesarean surgery. This approach not only offers simplicity but also enhances patient satisfaction, facilitating prompt mobilization, early bonding with the newborn, and efficient nursing care. 

Compared to systemic tramadol administration, Intraperitonial bupivacaine significantly reduces the need for systemic analgesics within the initial twenty-four hours post-surgery. Our statistical analysis supports the superiority of local bupivacaine injection in terms of pain relief and analgesic requirements. 

Therefore, based on our findings, Intraperitonial bupivacaine emerges as a less complex and more effective technique for achieving postoperative analgesia following cesarean procedures.

Conflict of Interest:

The authors declare that they have no conflict of interest

Funding:

No funding sources

Ethical approval:

The study was approved by the RMRI,bareilly.

REFERENCES
  1. Centers for Disease Control and Prevention. Rate of cesarean delivery among Puerto Rican women: Puerto Rico and the U.S. mainland 1992-2002. MMWR Morb Mortal Wkly Rep 2006; 55(3): 68-71. 

  2. Royal College of Obstetricians and Gynaecologists. Clinical Effectiveness Study Support Unit. The National Sentinel Caesarean Section Audit Report. London: RCOG, 2001. 

  3. Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct 1;101(4):1182-7. 

  4. Eisenach JC, Pan PH, Smiley R, Lavand‟homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. 

  5. Luana B, Olivia A Cassar, Mark P Brincat, George G Buttigieg, Anthony Serracino Inglott, Maurice Zarb Adami, Lilian M Azzopardi. Predictors of post Caesarean section pain and analgesic consumption. J Anaesthesiol Clin Pharmacol 2011 Apr-Jun;27(2):185-91.

  6. Malhotra N, Roy KK, Chanana C, Kumar S. Post-operative pain relief after operative gynecological laparoscopic procedures with Intraperitonial bupivacaine. Internet J Gynecol Obstet. 2005;5(2).

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