Introduction

In recent years in the world, including Iran, the rate of cesarean section has increased [1], so that cesarean section has become one of the most common surgeries in our country [1-2]. The incidence of cesarean section is reported to be 10%-20% at the international level and 50%-60% in Iran [3]. Acute pain after cesarean section is one of the known complications of surgery and effective pain management during cesarean section is a top priority in cesarean section [4]. There are several strategies for moderating pain in patients; however, despite the various treatments, there is still insufficient pain alleviation and patient satisfaction [5]. Many pharmacological and non-pharmacological methods are used during pregnancy and cesarean section to control pain, nausea, vomiting and shivering [6-9]. The drugs chosen for cesarean delivery are opioids such as morphine and pethidine [10]. The most common opioid used in gynecology and obstetrics is pethidine (meperidine), which has a duration of about 1-4 hours [11]. Pethidine is used to treat pain [12] and shivering [13] in women undergoing cesarean section. The use of new drugs, including nonsteroidal anti-inflammatory drugs (NSAIDs), α2 agonists, and anticholinergics, may play an important role in improving the effectiveness of conventional techniques by reducing complications due to the reduced need for opioids [14]. Both ketorolac and pethidine can cause analgesia after cesarean section [12]. Some have reported that diclofenac can significantly reduce postoperative analgesia [15]. Few trials have been conducted so far comparing intravenous pethidine and diclofenac suppository on pain after cesarean section with spinal anesthesia. The goal of this study was to examine the effects of intravenous pethidine and diclofenac suppository on pain following a cesarean section performed under spinal anesthesia.

Methods

This sub-study was extracted from main protocol (IR.HUMS.REC.1397.201) that was a double-blind randomized clinical trial on adult patients aged 20 to 40 years with ASA I, II. Candidates for elective cesarean section were chosen from Hormozgan Persian Gulf Hospital in 2018 from the same clinical trial about the primary outcome of shivering. This study received ethical code from the affiliated university (IR.HUMS.REC.1397.201). All patients were given the necessary explanations about the study and they declared their consent to participate in the study in written. All ethical considerations related to the Helsinki principles were taken into account in this study. Patients who had taken analgesics before surgery, those having contraindications to spinal anesthesia (high ICP, coagulation disorders, anticoagulants, and patients who had contraindications to NSAIDs or pethidine); ASA≥3, intraoperative hemorrhage, hysterectomy, and emergency patients were excluded. The sample size was calculated based on the study of Sarvari et al. [16] and the formula for determining the sample size in analytical studies was used for each group of 65 and a total of 130. Patients were randomly divided into two groups receiving intravenous pethidine and diclofenac suppository using a random number table. All standards needed for C-section under spinal anesthesia were considered according to the details are published elsewhere. 

After the baby was born, the first group was slowly injected with 0.5 mg/kg of intravenous pethidine and second group was given a 100 mg diclofenac suppository. Contraindications of prescribing any of these medications were considered for special circumstances. 

Study checklist included demographic variables (age, weight, sex) and systolic and diastolic blood pressure, before and after surgery and the duration of analgesia and pain intensity at the time of entry into recovery, 30 and 60 minutes in recovery and 2, 4 and 6 hours after surgery. At the same time, the intensity of pain was measured based on visual instrumentation of pain (VAS).

VAS of more than 3 was considered as pain incidence. Data were analyzed using SPSS software version 19 and descriptive statistics (mean-standard deviation-percentage, etc.) and independent t-test, one-way ANOVA with repeated measures and chi-square. P-value <0.05 was considered as a significant level.

Results

The baseline characteristics of this study subjects are reported in main clinical trial on shivering.  130 patients aged 20-40 years were entered the main clinical trial that did not differ in case of age and mean weight (details published elsewhere).

In intravenous pethidine group, the mean systolic blood pressure was 116.23±10.28 mm Hg, while in diclofenac suppository group, it was 115.91±10.72 mm Hg. There was no statistically significant difference in systolic blood pressure between the two groups at other times (Table 1).

Table 1: Hemodynamic (SBP) changes of study participants

The mean diastolic blood pressure Enter Recovery was 74.17±8.72 mm Hg in intravenous pethidine group and 71.15±7.79 mm Hg in diclofenac suppository group, which was a significant difference between the two groups (P = 0.22). At other times, there was no statistically significant difference between diastolic blood pressure between the two groups (Table 2).

Table 2: Hemodynamic (DBP) changes of study participants

At the time of Enter Recovery, 13 patients in intravenous pethidine group experienced pain and 52 did not report pain. Six patients in diclofenac suppository group reported pain and 59 did not feel pain. At 30 and 60 minutes postoperatively, there was a significant difference in the incidence of pain between the two groups (P <0.001 and P <0.014). At other times, there was no significant difference between the two groups.

Table 3: Pain incidence in study participants

Discussion

The high side effects and high cost of opioid drugs are the reasons for the routine use of NSAIDs as a]/DFEW, P[KGGGGGVWKEDICJSICKKLDUD9P was substantially different mostly in 30 and 60 minutes, indicating the group receiving pethidine had more pain. Taghinezhad et al., compared the effects of pethidine and diclofenac sodium on pain intensity after cesarean surgery in their research. Diclofenac sodium was more effective than pethidine in decreasing pain after a cesarean section, according to the findings of their research [21]. A similar study showed that the incidence of pain in the diclofenac group was significantly lower than in the pethidine group [22]. Another study indicated that diclofenac significantly reduced postoperative pain compared with pethidine [16]. Other studies also support that diclofenac could help analgesia after cesarean section [23].

The findings of the previous investigations are congruent with those of the current study. The incidence of pain in the diclofenac group was considerably lower than the pethidine group at 30 and 60 minutes in this trial.

Other medications are also being used in this era. Pethidine and ketorolac are shown to have similar effects on post C-section pain [24]. Also, acetaminophen was more effective in controlling pain in cesarean section women under spinal anesthesia than pethidine [25]. Mahdavi et al., compared the effectiveness of morphine and diclofenac in decreasing pain after a cesarean section. Diclofenac suppository lowered pain score in the first twenty-four hours after surgery, which was substantial in the first twelve hours, according to the findings of this study [26]. The findings of this study do not agree with those of Hidaka et al., [27] and Gin et al., [28] [12]. Both opioids and NSAIDs were equally beneficial in analgesia after cesarean section in both investigations.

Conclusion

The results of the present study showed that diclofenac suppository significantly reduced the incidence of pain after cesarean section compared with intravenous pethidine and had a more appropriate effect. Therefore, it is recommended to use diclofenac suppository to reduce the incidence of pain in patients who have undergone cesarean section.

Funding

This research did not receive any specific grant from fundig agencies in the public, commercial, or not-for-profit sectors.

Authors' contributions

All authors contributed to data analysis, drafting, and revising of the paper and agreed to be responsible for all the aspects of this work.

Conflict of Interest

There are no conflicts of interest in this study.

ORCID

Majid Vatankhah

https://www.orcid.org/0000-0002-2053-1138

Mehrdad Malekshoar

https://www.orcid.org/0000-0002-3361-5429

Tayyebeh Zarei

https://www.orcid.org/0000-0001-8605-7742

HOW TO CITE THIS ARTICLE

Pourya Adibi, Majid Vatankhah, Mehrdad Malekshoar, Bibi Mona Razavi, Tayyebeh Zarei. Post Cesarean Section Analgesic Effects of Intravenous Pethidine and Diclofenac Suppository after Spinal Anesthesia: A Randomized Clinical Trial. J. Med. Chem. Sci., 2022, 5(7) 1150-1155

https://doi.org/10.26655/JMCHEMSCI.2022.7.2

URL: http://www.jmchemsci.com/article_152305.html