Uncomplicated Singleton Pregnancies | Effects of Pregabalin on Post-cesarean Pain
Uncomplicated Singleton Pregnancies research study
What is the primary objective of this study?
Post-cesarean pain management is essential for early mobilization of the mother so that she becomes able to care of her newborn. There choices for postoperative analgesia include spinal, systemic, or both opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local anesthetic infiltrations of the wound, or transverse abdominis plane blocks, which are determined by drug availability, regional and individual preferences, resource limitations and financial considerations. The use of opioids is associated with adverse effects such as nausea, pruritus, sedation, and occasionally respiratory depression. Pregabalin is an anticonvulsant drug structurally related to the inhibitory neurotransmitter gamma amino butyric acid, that exerts its action by binding to the α-2-δ subunit of the voltage-dependent calcium channel. It reduces the release of the excitatory neurotransmitters and inhibits the hyperalgesia and central sensitization. A recent meta-analysis demonstrated that pregabalin reduce the postoperative 24 hours cumulative opioid consumption and opioid-related adverse effects namely, vomiting and visual disturbances after surgery. Compared with the use of pregabalin doses lower than 300 mg, the use of doses higher than 300 mg even reduced opioid consumption by 35%. It is not known if pregabalin is excreted in human milk. There is a case report on the extensive excretion of pregabalin in breast milk, but with low measured concentrations in infant as a consequence of maternal exposure during breast feeding. Food and Drug Administration recommends to discontinue nursing or to discontinue pregabalin in nursing mothers. Pre-delivery single exposure to pregabalin is expected to be safe for the newborns. Up to the authors' best knowledge, this is the first clinical study on the efficacy and safety of the administration of pregabalin before cesarean delivery. We hypothesis that the preoperative administration of a single dose of pregabalin will improve the quality of postoperative analgesia after cesarean delivery. This placebo-controlled study aims to compare the effects of preoperative administrations of single oral doses of pregabalin 150 mg and 300 mg on the postoperative pain scores, cumulative patient controlled morphine consumptions, neonatal Apgar and neurologic and adaptive capacity scores (NACS), and maternal and neonatal adverse effects in parturients scheduled to elective Cesarean delivery under spinal anesthesia.
Who is eligible to participate?
Inclusion Criteria: - spinal anesthesia - elective cesarean delivery - breech presentation - cephalopelvic disproportion - previous caesarean delivery - American Society of Anesthesiologists class I and II Exclusion Criteria: - communication barriers - cardiovascular diseases - renal diseases - hepatic diseases - endocrinal diseases - neuropsychiatric diseases - morbid obesity - diabetes mellitus - anaemia - bleeding disorders - prolonged P-R interval - hypersensitivity to pregabalin - receiving pregabalin - receiving anticonvulsants - receiving antidepressants - receiving antipsychotics - alcohol or drug abuse - Opiates abuse - benzodiazepines during the last week - pregnancy-induced hypertension - evidence of intrauterine growth restriction - fetal compromise
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Uncomplicated Singleton Pregnancies
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PlaceboNinety minutes before surgery, the parturients receive two identical placebo capsules
Drug:Pregabalin 300 mg groupNinety minutes before surgery, the parturients receive two capsules of pregabalin 150 mg
Drug:Pregabalin 150 mg groupNinety minutes before surgery, the parturients receive one capsule of pregabalin 150 mg and one placebo capsule
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placeboreceive two identical placebo capsules
Pregabalin 150 mg groupone capsule of pregabalin 150 mg
Pregabalin 300 mg grouptwo capsules of pregabalin 150 mg
Start Date: November 2012
Completed Date: June 2015
Phase: Phase 1
Primary Outcome: cumulative patient controlled morphine consumptions
Secondary Outcome: postoperative pain scores
Study sponsors, principal investigator, and references
Principal Investigator: Samah A El Kenany, MD
Lead Sponsor: Mansoura University