Intraoperative Ketamine for Chronic Postoperative Pain After Open-Heart Surgery

Sponsor
Bursa City Hospital
Study ID
NCT07490457
Status
Not Yet Recruiting

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Conditions

  • Cardiac Anaesthesia
  • Chronic Pain
  • Ketamine
  • Pain
  • Post Operative Pain, Acute
  • Post Operative Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine group — OTHER
    Ketamine group: Single IV bolus of ketamine 1 mg/kg administered after induction of anesthesia and prior to skin incision
  • Control Group — OTHER
    Control group: Single IV bolus of normal saline (placebo) labeled as study drug administered after induction of anesthesia and prior to skin incision.

Study Details

The goal of this interventional study is to determine whether a single intraoperative IV dose of ketamine can reduce postoperative chronic and acute pain and postoperative opioid requirements in adult patients undergoing open-heart surgery under general anesthesia. The main questions it aims to answer are: Primary outcome: Does a single-dose intraoperative IV ketamine reduce the presence and severity of pain at 3 and 6 months after surgery ? Secondary outcomes: Does it reduce acute postoperative pain scores, opioid consumption, and other recovery-related outcomes in the early postoperative period ? Researchers will compare a single-dose IV ketamine arm to a placebo arm to see if ketamine decreases chronic pain incidence at 3 and 6 months and improves acute pain/opioid-related outcomes. Participants will: Be randomized to receive either a single IV bolus of ketamine or placebo during surgery. Undergo standard general anesthesia and open cardiac surgery per protocol. Have postoperative pain assessed using Numeric Rating Scale (NRS) at extubation, 0, 3, 6, 12, 24, and 48 hours. Have opioid and additional analgesic use recorded, time to first rescue analgesic noted, and ICU/hospital length of stay tracked. Be evaluated for ICU delirium (CAM-ICU) and complete Quality of Recovery-15, Brief Pain Inventory-Short Form, and Pain Self-Efficacy questionnaires. Be followed up at 3 and 6 months for assessment of chronic postoperative pain.

Key Dates

First listed
Mar 24, 2026
Start date
Apr 15, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine Group
    After induction of anesthesia and prior to skin incision, 1 mg/kg IV ketamine labeled as the study drug will be administered.
  • Placebo Comparator: Control Group
    After induction of anesthesia and prior to skin incision, normal saline labeled as the study drug will be administered.

Primary Outcome Measure

Presence of postoperative chronic pain at 3 months [ Time Frame: From the day of surgery through 6 months postoperatively. ]

Central Contacts

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