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Completed

NCT Number: NCT02515422

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Kayseri Educational and Research Hospital

Kayseri, Turkey (Türkiye)

About this study

the Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA). The Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey). The Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®) plus subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®). The Group 4 (Placebo, n=30) received subcutaneous infiltration of 30 mL placebo (0.9% saline solution). All medications were diluted with sterile 0.9% saline solution to 30 ml solutions in the similar volume and shape syringes and were infiltrated subcutaneously along the skin wound edges and close to the fascia prior to skin closure. There were four separate syringes which were prepared by an anesthesiology technician for four different treatment groups labeled G1, G2, G3 and G4 containing the ketamine, bupivacaine, ketamine plus bupivacaine and normal saline solution. Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

Subcutaneous infiltration of ketamine

Other names: Ketalar

Bupivacaine

Drug

Subcutaneous infiltration of bupivacaine

Other names: Marcaine

Placebo (0.9% saline solution)

Drug

Primary outcomes

  1. Postoperative visual analog scale pain score

    Time frame: Postoperative 12 hours

Secondary outcomes

  1. Postoperative opioid consumption

    Time frame: Postoperative 12 hours

Sponsors and collaborators

Lead sponsor

Huseyin Aksoy

Other Gov

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2015
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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