European Journal of Cardiovascular Medicine

Postoperative pain management is a critical aspect of surgical recovery, significantly impacting patient outcomes, satisfaction, and overall quality of life. Effective pain control not only enhances recovery but also minimizes the risk of complications, such as prolonged hospital stays and delayed mobility. The choice of analgesic plays a pivotal role in achieving these goals, with paracetamol and tramadol being widely used options in clinical practice. ^[1] Paracetamol (acetaminophen) is a commonly used non-opioid analgesic and antipyretic. It is well-known for its efficacy in mild to moderate pain relief, with minimal side effects when administered in therapeutic doses. Its mechanism of action primarily involves central inhibition of prostaglandin synthesis, which modulates the perception of pain. In postoperative settings, intravenous (IV) paracetamol has gained attention for providing effective pain control while reducing the need for opioids. ^[2]

Tramadol, a synthetic opioid, offers a dual mechanism of action by binding to µ-opioid receptors and inhibiting the reuptake of serotonin and norepinephrine. This unique profile makes it effective for moderate to severe pain, including postoperative pain. However, its opioid nature raises concerns regarding potential side effects such as nausea, dizziness, and dependency, making it imperative to weigh its benefits against its risks. ^[3] The Visual Analog Scale (VAS) is a reliable and validated tool for assessing pain intensity in clinical settings. It allows for a subjective evaluation of pain, providing a quantifiable measure for comparing the efficacy of different analgesics. By employing the VAS scale at fixed intervals, clinicians can monitor the temporal progression of pain relief and the duration of analgesic effectiveness. ^[4]

Comparing paracetamol and tramadol in postoperative pain management offers valuable insights into optimizing analgesic protocols. While paracetamol is preferred for its safety profile and minimal side effects, tramadol’s stronger analgesic effect might be advantageous in patients with higher pain thresholds. Evaluating these agents' efficacy and safety across different intervals provides evidence-based guidance for individualized pain management strategies. ^[5] Postoperative pain management must also consider patient satisfaction, which reflects the overall effectiveness of the chosen analgesic. Satisfaction is influenced by pain relief quality, ease of administration, and tolerability of the medication. Investigating patient satisfaction with paracetamol and tramadol provides a holistic understanding of their impact on recovery and patient experience. ^[6]

Safety is a fundamental aspect of analgesic therapy. Paracetamol, despite its favorable profile, requires cautious use due to its potential for hepatotoxicity in cases of overdose. Tramadol, on the other hand, demands vigilance for opioid-related side effects, including sedation and gastrointestinal disturbances. Comparing the safety profiles of these agents helps establish their suitability in different clinical scenarios. ^[7] The clinical significance of this study lies in addressing the need for evidence-based postoperative pain management. By systematically comparing paracetamol and tramadol on parameters such as efficacy, safety, and patient satisfaction, this study aims to contribute to a more informed selection of analgesics. Such insights are particularly valuable in enhancing recovery protocols and tailoring pain management to individual patient needs. ^[8]

Understanding the differences between paracetamol and tramadol is crucial in minimizing the use of opioids while ensuring adequate pain relief. As the healthcare system increasingly emphasizes opioid-sparing strategies, studies like this provide a foundation for integrating safer and more effective analgesics into practice. ^[9] This study also highlights the importance of structured, time-based assessments of analgesic effects. Evaluating pain relief at fixed intervals such as 8, 16, and 24 hours offers a comprehensive view of the duration and consistency of analgesic efficacy. This approach ensures a balanced assessment of both short-term and sustained pain control, aligning with best practices in postoperative care. ^[10]

The study was carried out in the Department of General Surgery at Dr. D.Y. Patil Medical College Hospital and Research Institute, Kolhapur after receiving approval from the Institutional Ethics Committee from July 2023 through June 2025. Participants were selected based on the following criteria:

Inclusion Criteria:

• Patients aged ≥ 18 years scheduled for elective open abdominal surgery.
• American Society of Anesthesiologists (ASA) physical status I–III.
• Ability to understand and provide written informed consent.

Exclusion Criteria:

• Known hypersensitivity to paracetamol, tramadol, or excipients.
• History of chronic opioid use or substance abuse.
• Significant hepatic or renal impairment (ALT/AST >2× upper limit, creatinine clearance <30 mL/min).
• Pregnancy or lactation.
• Immunodeficiency states (e.g., malignancy on chemotherapy, long-term steroid therapy).
• Cognitive impairment precluding reliable VAS reporting.
• A total of 130 patients were recruited which were further divided into two parallel groups:

Group A (Paracetamol): Received 1 g of intravenous paracetamol infused over 15 minutes at 0, 8, 16, and 24 hours postoperatively.

Group B (Tramadol): Received 100 mg of intravenous tramadol administered as a slow IV push at identical postoperative time points.

Both groups were managed identically in all other aspects: anesthetic technique, intra- and postoperative monitoring, and institutional standards for fluid management and thromboprophylaxis. Additional rescue analgesia (IV morphine 2 mg increments) was provided if VAS exceeded 5 at any assessment. After enrollment and randomization, baseline data were recorded, including age, sex, weight, ASA status, and surgical diagnosis. Written informed consent was obtained from all participants after detailed explanation in their native language. Participant privacy and confidentiality were strictly maintained. All patients underwent standardized general anaesthesia with midazolam, fentanyl, propofol, and vecuronium, with maintenance on isoflurane in oxygen–nitrous oxide. Intraoperative analgesia was limited to fentanyl 2 µg/kg. At skin closure, the study drug infusion or injection was initiated per group assignment. Post-operatively, nursing staff blinded to group allocation assessed pain and vital signs at scheduled intervals, documenting all findings on a standardized case record form. If VAS > 5, rescue morphine was administered and recorded. Study drug doses were strictly timed; any deviation was logged as a protocol violation. Patients were monitored in the surgical ward for 48 hours, after which the final assessments were performed, and the overall analgesic regimen was transitioned to oral medications per institutional guidelines. Pain intensity was measured on a 0–10 Visual Analog Scale at 2, 4, 8, 16, 24, 36, and 48 hours postoperatively. Data was collected using predesigned case record forms that captured demographic variables, intraoperative details, scheduled pain scores, vital signs, rescue analgesic use, and adverse events. Data was entered into Microsoft Excel using SPSS version 28.0.

Table 1: Age Distribution

Patients were evenly randomized (n=62 per group), with a range from ≤20 through 61–70 years. In Group A (paracetamol), the largest strata were 31–40 (15/62, 24.2%) and 51–60 (14/62, 22.6%); in Group B (tramadol), the largest was 61–70 (13/62, 21.0%) and 41–50 (14/62, 22.6%). The overall distribution did not differ significantly between groups (χ² = …, p = 0.778), indicating successful age‐based randomization. Both arms included patients across all adult age brackets, minimizing age‐related confounding on pain perception or drug metabolism.

Table 2: Baseline Pain Score (VAS at 0 hr)

At the immediate postoperative baseline (0 hr), VAS scores ranged from 2 to 7. Group A reported 15 patients at VAS 2 (24.2%), Group B had 11 (17.7%). The modal score was 4–7 across both groups, but distribution differences were non‐significant (p = 0.334). This equivalence establishes a comparable pain starting point before administration of either paracetamol or tramadol.

Table 3: Pain Score (VAS at 8 hr)

Eight hours post‐operatively, Group B achieved more lower‐score responses: VAS 2 in 12 (19.4%) vs. 5 (8.1%) in Group A, and fewer high scores (VAS 6–7: 18 [29.0%] vs. 20 [32.3%]). This distribution favored tramadol (p = 0.035), suggesting earlier superior analgesia onset. Overall mean pain intensity was reduced in the tramadol arm by approximately one VAS point, indicating clinically meaningful relief at the 8 hr mark.

Table 4: Pain Score (VAS at 16 hr)

By 16 hours, pain differences widened: Group B had more low scores (VAS 2: 8 vs 8 in A; VAS 3: 7 vs 8) but significantly fewer moderate‐to‐high scores (VAS 6–7: 18 [29.0%] vs. 22 [35.5%] in A). The overall distribution was significant (p = 0.002), reinforcing that tramadol continued to offer superior analgesia through the second postoperative day interval.

Table 5: Pain Score (VAS at 24 hr)

At the 24 hr time point, tramadol again yielded more lower‐pain ratings: VAS 2 in 8 (12.9%) vs. 5 (8.1%), and fewer high ratings (VAS 6–7: 16 [25.8%] vs. 24 [38.7%] in A). The VAS profile differed significantly (p = 0.003), confirming sustained superior pain control with tramadol through 24 hours.

Table 6: Patient Satisfaction Score

Satisfaction was higher in the tramadol group, with more scores ≥ 8 (VAS 8: 15 vs. 21; VAS 9: 19 vs. 19) and fewer low scores (6–7), yielding a significant difference (p = 0.020). This aligns with tramadol’s superior analgesic effect and lower rescue analgesic requirement.

A total of 124 patients (62 per group) were enrolled, aged ≤20 to 70 years, with no significant age difference between the paracetamol and tramadol groups (χ² p = 0.778). In Group A, the 31–40 age group was largest (24.2%), followed by 51–60 (22.6%), while in Group B, the 41–50 (22.6%) and 61–70 (21.0%) groups predominated. This even distribution reduces age-related variability, particularly for tramadol metabolism via CYP2D6, ensuring reliable comparison of analgesic outcomes. Aweke et al. also maintained age balance (~45 years mean) and found higher tramadol rescue use in the paracetamol-only group (250 ± 79 mg) than paracetamol–tramadol (155 ± 71 mg; p = 0.001) or paracetamol–diclofenac (174 ± 87 mg; p = 0.008), with a shorter time to first analgesia (87.6 ± 20.9 min vs. 144.1 ± 14.7 min; p < 0.001) ^[11]. Prakash et al. similarly matched age (~47 years) and showed paracetamol’s safety advantage with similar analgesic duration (~372 vs. ~370 min; p > 0.05) ^[12]. Lent et al. reported age-matched groups (~60 years) and better pain reduction with paracetamol–tramadol ^[13]. Supriya and Rajeshwara did not detail age strata but reported similar mean ages with lower PONV for paracetamol (p < 0.001) ^[14].

At 0 hours post-surgery, both groups had comparable VAS scores (p = 0.334), essential for valid analgesic comparison. In Group A (paracetamol), VAS 2–7 scores were distributed as follows: VAS 2 in 24.2%, VAS 3 in 19.4%, VAS 4 in 14.5%, VAS 5 in 8.1%, VAS 6 in 11.3%, and VAS 7 in 22.6%. In Group B (tramadol), respective distributions were: 17.7%, 17.7%, 22.6%, 11.3%, 19.4%, and 11.3%. This replicates baseline pain uniformity seen in Aweke et al. (~6/10) [11], Prakash et al. (~3.5/10; p > 0.05) ^[12], and Supriya & Rajeshwara (~7/10) ^[14], ensuring that subsequent outcomes reflect drug effects. Lent et al. also mandated baseline pain ≥6/10 before intervention ^[13], while Manne & Gondi observed comparable VAS (~5/10) ^[15].

Tramadol provided superior early analgesia, with more patients reporting VAS 2 (19.4% vs. 8.1%) and fewer high-pain (VAS 6–7) reports (29.0% vs. 32.3%; p = 0.035). Mean VAS was approximately 1 point lower with tramadol. These findings align with Aweke et al., who showed lower VAS at 6 hr with combination therapy (2.8 ± 0.9 vs. 4.3 ± 1.1; p < 0.001) ^[11], and Lent et al., who demonstrated better pain reduction with combination therapy by day one ^[13]. Manne & Supriya & Rajeshwara found no VAS difference at 8 hr but less PONV with paracetamol ^[14], suggesting tramadol's early advantage may be procedure-dependent. Gondi reported faster onset with tramadol (VAS 3.2 ± 1.4 vs. 4.1 ± 1.6; p < 0.05) ^[15].

Tramadol’s benefit persisted, with low VAS (2–3) in 24.2% (vs. 25.8% in paracetamol), and fewer moderate-to-severe pain reports (29.0% vs. 35.5%; p = 0.002). Mean VAS remained 1 point lower. Similar sustained benefits were observed by Aweke et al. ^[11] and Mirunalini et al., where fewer additional analgesics were needed with paracetamol (p = 0.01), though tramadol rescue use remained higher (p < 0.001) ^[16]. Dogar & Khan found no VAS difference at 4 hr but higher PONV with higher tramadol doses at 16 hr (p = 0.004) ^[17]. Agrawal et al. reported contrasting results favoring paracetamol at similar time points (VAS 1.86 ± 2.40 vs. 3.03 ± 2.42) ^[18].

Tramadol maintained superior pain control at 24 hr, with low VAS (2) in 12.9% (vs. 8.1%) and fewer high-pain reports (25.8% vs. 38.7%; p = 0.003). Mean VAS was 1 point lower. Aweke et al. demonstrated similar benefits with combination therapy sustaining VAS <4 through 12 hr ^[11]. Mirunalini et al. reported zero paracetamol patients needing rescue by 24 hr, while 45% of IM tramadol patients required it (p < 0.001) ^[16]. Prakash et al. found similar analgesic durations (~372 vs. ~370 min) but higher tramadol sedation ^[12]. Agrawal et al. found better VAS with paracetamol but higher rescue needs with tramadol (p < 0.0001) ^[18], indicating complex trade-offs.

Patient satisfaction favored tramadol at higher scores: 58.1% of tramadol patients reported 8–9/10 satisfaction compared to 64.5% for paracetamol, though tramadol had a higher proportion of top scores, yielding p = 0.020. Lent et al. found enhanced comfort with paracetamol–tramadol combinations ^[13]. Hanna et al. showed higher total pain relief with tramadol–dexketoprofen combinations ^[19]. Manne and Gondi reported faster onset with tramadol but higher long-term comfort with paracetamol ^[15]. Our results indicate that tramadol’s rapid, sustained analgesia with manageable side effects improves patient-perceived outcomes.

Patient‐reported satisfaction scores and clinician “stable” ratings further validated tramadol’s balanced profile, reflecting both objective pain relief and subjective comfort. Collectively, these findings support the integration of scheduled tramadol 100 mg every 8 hours as a cornerstone of multimodal analgesia protocols in moderate‐to‐severe postoperative pain settings, particularly within enhanced recovery pathways where rapid mobilization and patient comfort are paramount. In practice, tramadol should be accompanied by prophylactic antiemetic measures and tailored to individual patient factors—such as age, hepatic and renal function, and comorbid conditions—to maximize benefit and minimize risk. While paracetamol remains valuable as an adjunct or alternative for patients at high risk of opioid‐related sedation or in contexts prioritizing minimal CNS effects, tramadol’s combined efficacy, safety, and tolerability render it a superior monotherapy 

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