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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 7  |  Issue : 2  |  Page : 85-89

Comparison of analgesic efficacy of wound infiltration with bupivacaine versus mixture of bupivacaine and tramadol for postoperative pain relief in caesarean section under spinal anaesthesia: A double-blind randomized trial


Department of Anaesthesiology, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India

Date of Web Publication7-Nov-2017

Correspondence Address:
Roopa Sachidananda
Department of Anaesthesiology, Karnataka Institute of Medical Sciences, Hubli, Karnataka - 580 021
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/joacc.JOACC_20_17

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  Abstract 


Background: Caesarean section is one of the most frequently performed surgeries in obstetrics. Optimal pain relief of the mother is possible with multimodal methods. Wound infiltration is one of the simplest and safe methods. The aim of the study was to compare the analgesic efficacy of wound infiltration of bupivacaine, with tramadol and bupivacaine mixture for postoperative pain. Materials and Methods: After obtaining Institutional Ethical Committee approval, 60 pregnant women of age group 18–35 years, undergoing elective caesarean section under spinal anaesthesia were included in the study. The patients were randomized into two groups of 30 each. Patients belonging to group B received bupivacaine 0.25% 0.7 mg/kg (diluted to 20 mL with normal saline), while those belonging to group T received tramadol 2 mg/kg mixed in bupivacaine 0.25% 0.7 mg/kg (diluted to 20 mL with normal saline). The time for first request of analgesia, numerical rating scale score, and cumulative consumption of diclofenac and tramadol in 24 h were compared. Results: The time for first request of analgesia in group T was 386.17 ± 233.84 min compared to group B which was 192.50 ± 134.77 (P < 0.0002). The total diclofenac consumption in the first 24 h was significantly reduced in group T when compared to group B (P < 0.0068). Conclusions: Subcutaneous wound infiltration with tramadol and bupivacaine prolongs the pain-free period and analgesic consumption after caesarean section, while it also enhances the patient satisfaction.

Keywords: Bupivacaine, caesarean section, tramadol, wound infiltration


How to cite this article:
Sachidananda R, Joshi V, Shaikh SI, Umesh G, Mrudula T, Marutheesh M. Comparison of analgesic efficacy of wound infiltration with bupivacaine versus mixture of bupivacaine and tramadol for postoperative pain relief in caesarean section under spinal anaesthesia: A double-blind randomized trial. J Obstet Anaesth Crit Care 2017;7:85-9

How to cite this URL:
Sachidananda R, Joshi V, Shaikh SI, Umesh G, Mrudula T, Marutheesh M. Comparison of analgesic efficacy of wound infiltration with bupivacaine versus mixture of bupivacaine and tramadol for postoperative pain relief in caesarean section under spinal anaesthesia: A double-blind randomized trial. J Obstet Anaesth Crit Care [serial online] 2017 [cited 2017 Nov 22];7:85-9. Available from: http://www.joacc.com/text.asp?2017/7/2/85/217770


  Introduction Top


Caesarean section is one of the most frequently performed surgeries in obstetrics.[1] Optimal pain relief of the mother results in early mobilization, initiation of breast feeding, and prevention of chronic pain syndromes. Multimodal analgesia is expected to provide high-quality analgesia. Wound infiltration with local anaesthetics is one of the simplest and widely used methods described for pain relief for many years.[2],[3],[4] Although various drugs have been used for infiltration, very few studies have reported tramadol wound infiltration for pain relief.[5]

The aim of the study was to compare the analgesic efficacy of wound infiltration of bupivacaine, with bupivacaine and tramadol for postoperative pain relief in caesarean section under spinal anaesthesia.


  Materials and Methods Top


After obtaining Institutional Ethical Committee approval, 60 pregnant women, between 18 and 35 years age, belonging to American Society of Anaesthesiologists' physical status I or II undergoing elective caesarean section under spinal anaesthesia were included in the study. Patients with severe cardiopulmonary, renal or liver disease, pre-eclampsia, eclampsia, morbidly obese, allergic to study drugs were excluded from the study. During the preoperative visit, detailed history and examination of the patients were done. Informed written consent was obtained. All patients were counselled and educated about reporting of the intensity of postoperative pain using the numerical rating scale (NRS), which is graded 0–10: 0 – no pain, 10 – worst pain imaginable.[6]

Routinely complete haemogram, urine for routine tests and microscopy, random blood sugar, blood urea, serum creatinine were performed for all the patients as an institutional protocol. All patients received tablet ranitidine 150 mg and tablet metoclopramide 10 mg the night before surgery and intravenous (IV) ranitidine 50 mg and IV metoclopramide 10 mg before induction of anaesthesia as per the institutional protocol.

Patients were randomly divided into two groups of 30 each using computer-generated random numbers. The computer-generated group numbers were enclosed in sealed envelope by a neutral observer who was not involved in the study. After the sealed envelope was opened, the same observer prepared the drug for wound infiltration.

Patients belonging to group B received bupivacaine 0.25% 0.7 mg/kg (diluted to 20 mL with normal saline), while those belonging to group T received tramadol 2 mg/kg mixed in bupivacaine 0.25% 0.7 mg/kg (diluted to 20 mL with normal saline).

In the operating room, patients were monitored with pulse oximeter (SpO2), electrocardiogram, and non-invasive blood pressure. All patients were co-loaded with Ringer lactate 10 mL/kg. Lumbar puncture was performed with a 25/26 G Quincke-type spinal needle in sitting position at L3/4 position. Subarachnoid block was established with 2.0–2.2 mL hyperbaric bupivacaine 0.5% (patients with height 145–150 cm received 2 mL and those between 150 and 160 cm received 2.2 mL). All patients received fentanyl 1–1.5 μg/kg and midazolam 1–2 mg IV after the delivery of the baby.

The study drug was administered subcutaneously at the time of skin closure on both sides of incision by the operating obstetrician. Pain score was to be assessed at 15, 30, 60 min and 2, 6, 12, 24 h after arrival in the recovery room either by the anaesthesiologist or ward nurse who were unaware of the drug administered for wound infiltration. Diclofenac sodium 75 mg IV was administered as a rescue analgesic if at any time pain score was more than 3 or the patient complained of pain. Tramadol 1 mg/kg IV was administered in the recovery room in addition to diclofenac if required. Sedation was measured using four-point scale as per Filos [7]: 1 = Alert and awake; 2 = Drowsy responsive to verbal stimuli; 3 = Drowsy arousable to physical stimuli; 4 = Unarousable. The consumption of metoclopramide and the rescue analgesics (diclofenac and tramadol) over the first 24 h following surgery was noted. At the end of the 24 h, the patient was asked about quality of pain relief using the following score: Excellent (4); very good (3); good (2); poor (1).

Incidence of nausea, vomiting, and shivering was noted. Nausea or vomiting was managed with IV metoclopramide 0.15 mg/kg.

Statistical analysis

Data were analysed using Statistical Package for the Social Sciences (SPSS) version 20. Results were expressed as mean ± standard deviation (SD). Demographic data which included age, height, and weight were compared using unpaired t-test. Categorical data were analysed using Mann–Whitney U-test and Chi-square test. P < 0.05 was considered statistically significant.

Based on the previous study,[8] to detect a 30% decrease in postoperative analgesic consumption with α = 0.05 and power of 80% with a confidence interval of 95%, 26 patients would be required in each group. To compensate for data loss, 30 patients were recruited in each group.


  Results Top


Sixty patients were enrolled in the study and all the patients completed the study. There was no significant difference between the groups with regards to age, weight, height, duration of surgery, and intraoperative fentanyl that was administered [Table 1].
Table 1: Demographic data, duration of surgery, and intraoperative fentanyl administered

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The time for first request of analgesia in group T was 386.17 ± 233.84 min compared to group B which was 192.50 ± 134.7, which was statistically significant (P = 0.0002). The total diclofenac consumption in the first 24 h was significantly reduced in group T when compared to the group B (P = 0.0068) [Table 2].
Table 2: Postoperative rescue analgesic and metoclopramide consumption in 24 h, time for first request of analgesia, postoperative patient satisfaction score

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Eleven patients in group B and 4 patients in group T required IV tramadol in addition to diclofenac. The NRS scores recorded over 24 h are shown in [Table 3]. The scores were comparable at all times except at first and second hour. The score was statistically higher in group B (P = 0.0039; P = 0.0484). The patient satisfaction score is as shown in [Table 2].
Table 3: Comparison of two groups B and T with NRS scores at different time points

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The haemodynamic parameters, i.e., mean arterial pressure (MAP) and heart rate (HR), measured at different times were comparable between both the groups [Figure 1] and [Figure 2]. The incidence of nausea, vomiting, shivering, and metoclopramide consumption was similar in both the groups [Table 4].
Figure 1: MAP of group B and group T at different time points

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Figure 2: Mean heart rate of group B and group T at different time points

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Table 4: Side effects

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The sedation scores were comparable between both the groups at all times except at first 15 and 30 min when the scores were higher in group T (P-value at 15 min is 0.0147, and 0.0133 at 30 min). However, the intraoperative fentanyl and midazolam administered were comparable among the groups.


  Discussion Top


Single-shot spinal anaesthesia is the most commonly employed anaesthesia technique for elective caesarean section.[9] Such patients experience moderate to severe pain in the postoperative period. Good pain relief is possible with multimodal analgesia. Developing countries face challenge of limited supply of opioids, lack of facilities for patient-controlled analgesia, and lack of infusion pumps.[10] Hence wound infiltration along with systemic non-steroidal anti-inflammatory drugs appears to be an attractive alternative to manage pain.

Tramadol is a synthetic 4-phenyl-piperidine analogue of codeine. It is μ receptor agonist. The non-opioid mechanism is mediated through α2 and serotonergic pathway. It inhibits the reuptake of norepinephrine and hydroxyl-tryptamine from the nerve endings. Recently, a few studies have reported anti-inflammatory and local anaesthetic action on peripheral nerves.[11],[12],[13],[14] Various advantages have been described for subcutaneous administration of drugs, which include avoiding first-pass metabolism, improved patient comfort, and good analgesia.[15]

Tramadol has less potential for abuse and respiratory depression, unlike the commonly used opioids. Besides, it is available easily over the counter.[11],[16] In our study, tramadol when used along with bupivacaine significantly prolonged the time to first analgesic request. The average consumption of diclofenac was significantly less in the group T. We believe that tramadol and bupivacaine could have acted synergistically, which might have contributed to prolonged pain-free period.

Subcutaneous bupivacaine has been used for pain relief in caesarean section.[17] Wound infiltration with bupivacaine has been shown to reduce the levels of interleukin 10 and increase substancePin the wound.[18] Local anaesthetics administered subcutaneously exhibit bacteriostatic and bactericidal action.[19]

Caesarean wound infiltration with tramadol 2 mg/kg for patients who underwent general anaesthesia was found to be a useful technique to reduce postoperative pain and improve recovery. Tramadol wound infiltration resulted in insignificant plasma levels (0.02–0.09 ng/mL), which was much lower than the therapeutic level (100–300 ng/mL), indicating possible local effects of tramadol.[8] This might also be the reason for significantly less incidence of unpleasant side effects such as postoperative nausea and vomiting (PONV), which is further substantiated by the similar findings from our study. The number of patients with PONV in group T were 5 when compared to group B, which was 12. Of these, 4 patients of group B and 1 patient of group T received IV tramadol.

Another study reported significantly high incidence of nausea and vomiting where subcutaneous tramadol 2 mg/kg infiltration was performed as a pre-emptive analgesic for patients undergoing lower abdominal surgeries performed under general anaesthesia.[20] In our study all patients received metoclopramide premedication before the surgery as an institutional protocol. A total of 11 patients in group B received IV tramadol when compared to group T (4 patients). This could have resulted in higher incidence of PONV in group B.

Studies done on other lower abdominal surgeries (appendectomy, inguinal herniorrhaphy) where subcutaneous tramadol has been given for postoperative pain relief have shown better analgesia compared to placebo.[21],[22]

Although tramadol was an effective drug in prevention of post-spinal shivering, in our study, the incidence of shivering was same in both the groups.[23] Shivering was observed over 24 h and various factors which influenced shivering were not considered in our study.


  Conclusion Top


Subcutaneous wound infiltration with tramadol and bupivacaine prolongs the pain-free period and analgesic consumption after caesarean section, while it also enhances the patient satisfaction.

Acknowledgments

Dr. Vikram Bhat K Professor, Department of ENT, KIMS Hubli. Dr. Arpita, Dr. Yeshwanthi, Dr. Shoba Post graduate students, Department of Anaesthesia, KIMS, Hubli.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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Altunkaya H, Ozer Y, Kargi E, Ozkocak I, Hosnuter M, Demirel CB, et al. The postoperative analgesic effect of tramadol when used as subcutaneous local anesthetic. Anesth Analg 2004;99:1461-4.  Back to cited text no. 15
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Carvalho B, Clark DJ, Yeomans DC, Angst MS. Continuous subcutaneous instillation of bupivacaine compared to saline reduces interleukin 10 and increases substancePin surgical wounds after cesarean delivery. Anesth Analg 2010;111:1452-9.  Back to cited text no. 18
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Jabalameli M, Safavi H, Honarmand A, Saryazdi H, Moradi D, Kashefi P. The comparison of intraincisional injection tramadol, pethidine and bupivacaine on postcesarean section pain relief under spinal anesthesia. Adv Biomed Res 2012;1:53.  Back to cited text no. 20
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