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

Ketamine

Brief 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.

Intervention / Treatment

  • Ketamine (DRUG)
    Subcutaneous infiltration of ketamine
  • Bupivacaine (DRUG)
    Subcutaneous infiltration of bupivacaine
  • Placebo (0.9% saline solution) (DRUG)
    N/A

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 120 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2014
    Primary Completion: May 01, 2015 ACTUAL
    Completion Date: May 01, 2015 ACTUAL
    Study First Posted: Aug 04, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 03, 2015

    Sponsors / Collaborators

    Lead Sponsor: Huseyin Aksoy
    Responsible Party: Huseyin Aksoy

    Location

    Kayseri, Turkey

    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.

    Participant Groups

    • Ketamine, 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA) was administered subcutaneously before the closure of pfannenstiel incision.

    • Bupivacaine 0.5% 20 mL (100 mg) (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey) was administered subcutaneously before the closure of pfannenstiel incision.

    • Ketamine 1 mg/kg (Ketalar®) and bupivacaine 0.5% (100 mg) (Marcaine®) were administered subcutaneously before the closure of pfannenstiel incision.

    • Placebo (0.9% saline solution) was administered subcutaneously before the closure of pfannenstiel incision.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • Postoperative visual analog scale pain score Postoperative 12 hours
    Secondary Outcomes
    • Postoperative opioid consumption Postoperative 12 hours

    More Details

    NCT Number: NCT02515422
    Other IDs: 2014/99
    Study URL: https://clinicaltrials.gov/study/NCT02515422
    Last updated: Sep 29, 2023