Effects of Pregabalin on Post-cesarean Pain

NCT01719705 | Completed Phase 1 DMC

• 1 other identifier: R/60
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Uncomplicated Singleton Pregnancies

Keywords

caesarean delivery; spinal anesthesia; pregabalin; postoperative pain; morphine

Outcome Measures

Primary Outcomes (1)

• cumulative patient controlled morphine consumptions

  cumulative patient controlled morphine consumptions 24 hours after delivery

  24 hours after delivery

Secondary Outcomes (5)

• postoperative pain scores

  1, 4, 6, 12, 24 and 48 hours after delivery

• neonatal Apgar scores

  1 and 5 min aftr delivery

• Neurologic and adaptive capacity scores

  at 15 min, 2h, 24 and 48 h after delivery

• Maternal sedation

  every two hours after delivery, for 48 hours after delivery

• Maternal nausea and vomiting

  at 24 hours after delivery

Other Outcomes (1)

• Adverse effects

  24 hours after delivery

Study Arms (3)

Placebo

PLACEBO COMPARATOR

receive two identical placebo capsules

Drug: Placebo

Pregabalin 150 mg group

ACTIVE COMPARATOR

one capsule of pregabalin 150 mg

Drug: Pregabalin 150 mg group

Pregabalin 300 mg group

ACTIVE COMPARATOR

two capsules of pregabalin 150 mg

Drug: Pregabalin 300 mg group

Interventions

Placebo DRUG

Ninety minutes before surgery, the parturients receive two identical placebo capsules

Placebo

Pregabalin 300 mg group DRUG

Ninety minutes before surgery, the parturients receive two capsules of pregabalin 150 mg

Pregabalin 300 mg group

Pregabalin 150 mg group DRUG

Ninety minutes before surgery, the parturients receive one capsule of pregabalin 150 mg and one placebo capsule

Pregabalin 150 mg group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• spinal anesthesia
• elective cesarean delivery
• breech presentation
• cephalopelvic disproportion
• previous caesarean delivery
• American Society of Anesthesiologists class I and II

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

College of Medicine, Mansoura University

Al Mansurah, DK, 050, Egypt

Location

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin; Population Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Demography; Population Characteristics

Study Officials

• Samah A El Kenany, MD

  Anethesiology Dept, College of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed R El Tahan, M.D.

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & SICU

Study Record Dates

• First Submitted: October 28, 2012
• First Posted: November 1, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

EG (2)