Efficacy of pregabalin as adjuvant analgesia to diclofenac sodium in laparotomies for benign gynaecological diseases: A randomized controlled trial

Background: Abdominal surgeries are considered one of the most painful among all types of surgeries. About 70% of patients who had abdominal surgeries suffered from severe pain in the postoperative period especially the gynaecological one. This pain as well as fatigue is the two key causes of prolonged convalescence following abdominal surgery. In order to relieve pain and fatigue, a current predominant approach of multimodal postoperative analgesia is used, mostly based on a combination of opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol and perioperative administration of local anesthetics. Each of these different approaches has its own set of complications.
Objective: The current study aimed to assess the efficacy of oral pregabalin 150 mg as adjuvant analgesic to i.v diclofenac sodium 75mg.
Patients and Methods: A randomized controlled trial was done on female patients who had laparotomies for benign gynaecological diseases in Ain Shams University Maternity Hospital during duration of nine months. The trial included one hundred and sixteen patients, divided into two equal groups. The first group (group A) received oral pregabalin 150 mg with i.v diclofenac sodium 75 mg one hour before operation and 12 hours after operation and was repeated every 12 hours for the first 24 hours and/or in demand. The second group (group B) received intravenous diclofenac sodium 75 mg 12 hours after operation and was repeated every 12 hours for the first 24 hours and/or in demand. The primary objective is measuring pain six hours postoperative and every one hour by using VAS-100 score, the secondary objective is measuring patient ambulation and audible intestinal sounds 6 hours postoperative.
Results: Pain perception was significantly lower among group A than group B. As on VAS study group record of 20-10, control group record 45-30. Analgesia-free time was significantly lower among study than among control by 2 hours. Side effects were more frequent among study than among control group, but the differences were significant only in somnolence. This study showed also a significant early post-operative mobilisation in those who took oral pregabalin 150 mg in comparison to those who took i.v diclofenac sodium 100 mg that is attributed to decrease pain perception. It revealed also no significant difference between both groups regarding the intestinal activity.
Conclusion: Administration of oral pregabalin 150 mg preoperatively reduce post-operative pain following abdominal gynecological operation, decrease the need of usage of post-operative narcotic analgesic, early patient mobilization that finally improve the surgical outcome and the patient quality of life.