Abstract
Objective: To evaluate the synergistic effect of a Selective Serotonin Reuptake Inhibitor (SSRI) and a Selective Cyclooxygenase 2 Inhibitor (ISCOx-2) in the management of After Rachianesthesia Headache in Obstetric Care. Patients and Methods: This was an experimental double-blind, randomized, multi-center clinical trial of non-inferiority clinical trials over a 12-month period (May 1, 2018 to April 30, 2019) in six hospitals in southeastern DR Congo, including all patients undergoing surgery or analgesia on spinal anesthesia for obstetrical indication and with headache characteristic of a dural breccia, with no known causes, contraindications to experimental products and informed consent to been obtained. The patients were divided into four different groups depending on the protocol used, namely: Group A = Rehydration + Paracetamol, Group B = Rehydration + Celecoxib, Group C = Rehydration + Nefopam and Group 4 = Rehydration + Celecoxib + Nefopam (Study Group). Using the Statview II software, the statistical analyzes of data obtained from the different tests were made using the ANOVA test for comparing the averages of different samples using the Fisher test. Verification of the normality of the samples was made by the Kurtosis and Skewness flattening and asymmetry test. Results: The protocol associating Celecoxib and Nefopam significantly demonstrates its effectiveness in reducing CPRAOs in the first two days with a gradual decrease in anxiety and length of stay. In addition, the majority of patients (75.6%) had a high overall level of satisfaction with this protocol. Conclusion: The Nefopam-Celecoxib combination shows its effectiveness in the early reduction of these CPRAOs, anxiety and length of stay with a high overall level of patient satisfaction. Given the good tolerance and accessibility of these products, we strongly suggest the use of this protocol for its validation in our environment and elsewhere, although it is desirable to continue research on other non-explored alien pathways.
Highlights
Headache after break-in is a complication of spinal anesthesia and an accidental dural breach during anesthesia or epidural analgesia
Couraging to us to test any possible analgesic synergy on these headaches in this obstetric population which remains the most affected. This is why in order to contribute to the resolution of this worrying problem in our environment and mainly in obstetrics, we proposed to conduct this study whose objective is to assess the synergistic effect of a Selective Inhibitor Serotonergic Recapture (SSRI) and a Selective Cyclo-Oxygenase 2 Inhibitor (ISCOx-2) in the management of CPRAO
2) Evaluation of the intensity of headache postoperatively according to the analgesic protocols used (Tables 1-5) 3) Evaluation of the length of post-operative stay of the operated patients having presented CPRAO according to the protocols used (Table 6) 4) Assessment of the level of anxiety of the operated patients having presented CPRAO according to the protocols used (Tables 7-9) Line in the middle of the rectangle: median; Line at the bottom of the rectangle: first quartile (25%); Line in the upper part furthest from the rectangle: third quartile (75%); Item: outlier; Lowest line: lowest value, excluding outliers; Line at the extreme top: highest value, excluding outliers. (Figure 2)
Summary
Headache after break-in is a complication of spinal anesthesia and an accidental dural breach during anesthesia or epidural analgesia. Several preventive and curative measures have been studied, but none has proven to be effective enough except the Epidural Blood patch, which was not the only treatment of choice given that rehydration and other drugs like sumatriptan, morphine drugs, adrenocorticotropic hormone (ACTH), opiates, nonsteroidal anti-inflammatory drugs have been tested in isolation leading to controversial results [1] [2] [8] [9] This therapeutic difficulty remains a serious problem, especially for countries with limited resources where these headaches are increasing rapidly in obstetric settings (27.5%), this same study in DR Congo has just developed a reproducible predictive score from determinants specific to the environment and the obstetrical population [10]. Knowing today the remarkable benefit of a combination of analgesics acting at the same time on several pain signaling pathways and subscribing to the concept of “multimodal or balanced” analgesia, it seems en-
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