Abstract
Background:
Major surgical procedures, such as gastrectomy, result in extensive postoperative pain, which can lead to increased morbidity, discomfort and dissatisfaction among the patients.Objectives:
The aim of this study was to evaluate the effect of adding diclofenac suppositories or intravenous paracetamol, on morphine consumption and on the quality of postgastrectomy pain control.Patients and Methods:
This randomized double blinded clinical trial was carried out in 90 patients with gastric cancer, who were candidates for gastrectomy, which were divided into three similar groups. The patients were transferred to an intensive care unit after the operation and received patient-controlled analgesia (PCA) with morphine, morphine PCA plus intravenous paracetamol 1 g, every 6 hours, and morphine PCA plus diclofenac suppositories, 100 mg every 8 hours. The patients were evaluated for up to 24 hours after the operation for the severity of pain, alertness, and opioid complications.Results:
There was no significant difference in pain scores among the three groups (P values, after extubation, at 2, 4, 6, 12, 18 and 24 hours were 0.72, 0.19, 0.21, 0.66, 0.54, 0.56, and 0.25, respectively), although morphine consumption was greater in the morphine group, compared with the other two groups (21.4 ± 7.7 mg in morphine group vs. 14.3 ± 5.8 mg in morphine-paracetamol group and 14.3 ± 3.9 in morphine-diclofenac group; P = 0.001). In morphine group, during the first 24 hours, the patients had lower levels of consciousness (P values, after extubation, at 2, 4, 6, 12, 18 and 24 hour were 0.6, 0.95, 0.28, 0.005, 0.027, 0.022 and 0.004 respectively), even though the incidence of complications was similar among the three groups.Conclusions:
In this study, intravenous paracetamol or diclofenac suppositories, administered for postgastrectomy pain control, decreased morphine consumption by almost 32% and also improved alertness. Nevertheless, the amount of opioids did not affect the incidence of complications.Keywords
Acetaminophen Diclofenac Morphine Gastrectomy Pain Management
1. Background
Acute postoperative pain is a complex physiological reaction, due to damage and inflammation, which increases morbidity, mortality rate, costs, and also reduces patient satisfaction (1, 2). Postoperative pain leads to the pulmonary, cardiac and metabolic complications, impaired ulcer healing, and restlessness. Therefore, pain control is important for prevention and treatment of complications (3-5). Postoperative pain intensity varies depending on the type and place of surgery and is higher in major surgeries, such as laparotomy (6).
Different methods are used for postoperative pain control. Therapeutic regimens depend on type of surgery, age, physical and mental states of patients (7). In major surgeries, such as gastrectomy, combined and multi-drug methods are recommended (8, 9). The opioids, non-steroid anti-inflammatory drugs (NSAIDs), and paracetamol are commonly used for pain control (10, 11). Performing nerve blocks or intraspinal injection of opiates can be useful in thoracotomy, hepatic resection, and esophagectomy (12-14). Combination of these methods improves quality of pain control (due to interaction with different mechanisms) and also reduces opioid and NSAIDs dosage and complications (respiratory depression, dependency, renal failure, gastrointestinal bleeding, etc.). In 1995, The American Society of Anesthesiologists presented a guideline for acute postoperative pains, with emphasis on the standardization of care and use of epidural analgesia, patient controlled analgesia (PCA), and concurrent analgesic methods (15).
Although different studies have been conducted on pain control, after a search in PubMed, Medline, SCOPUS and Cochrane database, no studies have been identified regarding the postgastrectomy pain.
2. Objectives
The aim of our study was the evaluation of adding intravenous paracetamol or diclofenac suppository on the dose of morphine, using the patient controlled analgesia method and also, the improvement of quality of postgastrectomy pain control and consciousness.
4. Results
This study was conducted on 90 patients, aged 40 - 70 years old, with gastric cancer in three similar groups, with flow diagram. Demographic and clinical information are shown in Table 1. There was no statistically significant difference between the three groups, for age, gender, weight, surgery and recovery duration (from tracheal extubation to transfer to the ICU).
Demographic Parameters in the Three Groups a
| Parameters | Morphine | Morphine-Paracetamol | Morphine-Diclofenac | P Value |
|---|---|---|---|---|
| Gender | 0.14 | |||
| Male | 19 | 21 | 23 | |
| Female | 11 | 9 | 7 | |
| Age, y | 65.3 ± 11.3 | 66.8 ± 10.1 | 63.8 ± 12.6 | 0.6 |
| Weight, Kg | 62.8 ± 17.8 | 63.4 ± 10.9 | 65.9 ± 9.4 | 0.21 |
| Duration of surgery, min | 273.3 ± 51.9 | 251 ± 76.2 | 269.5 ± 68.4 | 0.44 |
Consciousness level of the patients was not significantly and clearly different in the three groups, in the first 4 hours after the surgery, in the ICU. However, it was significantly different after 4 hours among three groups (P values, after extubation, at 2, 4, 6, 12, 18 and 24 hours, were 0.6, 0.95, 0.28, 0.005, 0.027, 0.022 and 0.004, respectively). Figure 1 shows the difference between morphine group and the paracetamol and diclofenac groups, in terms of consciousness level.
Pain rating scale, during 24 hours, in the three groups, is demonstrated in Figure 2. There was no significant difference between the groups, in terms of pain intensity (P values, after extubation, at 2, 4, 6, 12, 18 and 24 hours, were 0.72, 0.19, 0.21, 0.66, 0.54, 0.56 and 0.25, respectively). Nevertheless, pain reduction during 24 hours was significant in all the three groups (P = 0.00).
Consciousness State in the Three Groups
Pain Scores of the Three Groups During 24 Hours
Morphine intake in M group was 32% higher than in the MP (P = 0.00) and MD (P = 0.00) groups (Table 2), although the morphine intake between MD and MP groups was not significantly different (P = 0.75). The relationship between consciousness and morphine intake was significant after 4 hours (P value was 0.49, 0.99, 0.043, 0.006, 0.048, 0.001, and 0.00, after extubation, the 2nd, 4th, 6th, 12th, 18th, and 24th hour, respectively). Complications of morphine intake, such as arterial desaturation, nausea, vomiting, and itching, are shown in Table 2 there was no significant difference between the three groups.
5. Discussion
Patients experience severe postoperative pain, in the first 24 hours. Pain intensity depends on surgery type and therapeutic protocol. In our previous study (in laparotomy), maximum tolerated pain during the first hours was 8.4 ± 1.2 and mean pain of the patients has been reported as 5.8 ± 1.9, in the first 24 hours, without appropriate protocol (17). In this study, by adding paracetamol and diclofenac to PCA morphine method, the effect of these drugs on pain control was comparable.
Pain intensity was identical in the three groups, during 24 hours. However, morphine intake in MP and MD groups was less than in the M group. After the first 4 hours, consciousness level of the patients in the M group was lower than that in MP and MD groups, which could be the result of higher intake of morphine, in this group. Despite reduction of morphine intake, there was no significant difference among the groups for opioid complications, such as nausea, vomiting, itching, and oxygen desaturation, due to same pain intensity in the three groups and supplementary oxygen.
Laparotomy is accompanied by high postoperative pain, which is due to wide incision and more manipulations (9). Different methods have been used for controlling postoperative pain. Nevertheless, use of oral and intravenous compounds is more applicable. Using opiates by PCA method, along with paracetamol, diclofenac, or both, is a suitable method for pain control. The combination therapy is more effective and reduces pain intensity and need for additional analgesics (18). For example, the combination of these two drugs after caesarean section reduces the need for morphine intake by 38% (19).
In another study for pain control, among the patients undergoing coronary artery bypass grafting, morphine + diclofenac, morphine + diclofenac + paracetamol, and morphine alone groups were compared. In this study, it was found that morphine intake in the control group was significantly higher than that in the group receiving diclofenac and diclofenac + paracetamol during 24 hours. The period until extubation was longer, oxygenation level was lower, and nausea and vomiting rates were higher in the control group, compared with the other two groups (16).
Indeed, same results cannot be always found. For example, in a study which was conducted on children after appendectomy, pain intensity and morphine intake were significantly reduced after suppository diclofenac. However, it was not effective in reducing pain (20).
Results of the present study were similar to most of the previous works, confirming improvement of pain quality and reduction of morphine intake by concurrent use of diclofenac or paracetamol and morphine.
In several studies, there is controversy over the use of acetaminophen for severe postoperative pain control. In a systematic review on the results of seven studies, including 265 patients, adding acetaminophen did not reduce complications of morphine or increase patient satisfaction; however, adding acetaminophen to morphine pump reduced the need for morphine by 20% during the first 24 hours after the surgery (21). Intake of some compounds such as diclofenac is sometimes accompanied by several complications, such as increased bleeding (10).
In the present investigation, adding diclofenac suppository or paracetamol infusion had an identical effect on pain intensity control and intake of opiates and reduced average morphine intake within the first 24 hours after the surgery, in both groups, by 32%, which could justify a better consciousness of the patients in these two groups. Lack of difference in consciousness level in the first 4 hours may be due to the residual effect of anesthesia drugs and using morphine in the last hours of surgery.
Our study has several limitations, as follows: Pain scores are measured at fixed time, resulting that the length of analgesic effect of drugs could not be investigated and also, the primary outcome of this study was rescue analgesic requirement, which may not truly reflect the efficacy of these analgesics.
Adding intravenous paracetamol 1 g q6h, or suppository diclofenac 100 mg q8h to the pain control protocol with PCA morphine after gastrectomy reduced morphine intake by 32% at the same rate, which led to better consciousness of the patients within the first 24 hours after the surgery. However, it had no effects on other complications of morphine, such as nausea, vomiting, and itching (1).
Acknowledgements
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