Subcutaneous Wound Infiltration of Ketamine or Bupivacaine Pain Perception After Cesarean Section

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2015
• Main ID: NCT02515422
• Date of registration: 29/07/2015
• Prospective Registration: No
• Primary sponsor: Huseyin Aksoy
• Public title: Subcutaneous Wound Infiltration of Ketamine or Bupivacaine Pain Perception After Cesarean Section
• Scientific title: Subcutaneous Wound Infiltration of Ketamine is Superior to Bupivacaine in Terms of Pain Perception and Opioid Consumption After Cesarean Section: a Double-blinded Randomized Placebo Controlled Clinical Trial.
• Date of first enrolment: June 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02515422
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
• Phase: Phase 1

Countries of recruitment

Turkey

Key inclusion & exclusion criteria

Inclusion Criteria:

- singleton term pregnancy,

- between 38-41th weeks of gestation,

- absence of any medical or obstetrical problems.

Exclusion Criteria:

- multiple pregnancies,

- intrauterine fetal deaths,

- active stage of labor,

- obstetric emergencies such as antepartum hemorrhage, eclampsia and acute fetal
distress,

- special request for general anesthesia,

- history of allergic reaction or sensitivity to any of the drugs used in the study,

- reflected anxiety and depression during the cesarean operation,

- any systemic diseases (chronic hypertension, thyroid diseases, renal or hepatic
insufficiency, psychiatric disorders,

- chronic pain syndrome, epilepsy or intracranial hypertension)

- medications that would affect the perception of pain,

- current or past history of narcotic use or a history of narcotic abuse,

- inability to understand how to score a 10-cm visual analogue scale (VAS) for pain.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Postoperative Pain

Intervention(s)

Drug: Placebo (0.9% saline solution)

Drug: Ketamine

Drug: Bupivacaine

Primary Outcome(s)

Postoperative visual analog scale pain score [Time Frame: Postoperative 12 hours]

Secondary Outcome(s)

Postoperative opioid consumption [Time Frame: Postoperative 12 hours]

Secondary ID(s)

2014/99

Source(s) of Monetary Support

Please refer to primary and secondary sponsors