drugset / Trial / NCT02515422

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

NCT02515422

Phase 1 Completed 120 enrolled Huseyin Aksoy
RandomizedParallel-groupTriple-blindSupportive care

Summary

Aim: To assess the analgesic efficacy of subcutaneous infiltration of ketamine, either alone or as an adjuvant to bupivacaine, following CS and to compare their effects on postoperative pain scores and opioid consumption. Methods: Included patients were allocated to four treatment groups using computer-generated randomization number chart as follows; Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine, Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of bupivacaine 0.5%, Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine+bupivacaine 0.5% and Group 4 (Placebo, n=30) received subcutaneous infiltration of placebo (0.9% saline solution). Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications. VAS scores at resting and on coughing and analgesic consumptions were compared.

Timeline

Start
2014-06
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 100 mg Subcutaneous
Comparator Ketamine Small molecule 1 mg/kg Subcutaneous

Indications

No indication recorded.