Effect of Intraoperative Ketamine Administration on Postoperative Chronic Pain in Patients Undergoing Open Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Presence of postoperative chronic pain at 3 months
Study Overview
Brief Summary
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.
Detailed Description
The effect of intraoperative ketamine on postoperative chronic pain, acute pain, and postoperative opioid requirements will be evaluated in patients undergoing median sternotomy open-heart surgery under general anesthesia.
This study is a prospective, randomized, controlled, double-blind trial comparing intraoperative intravenous ketamine administered before the surgical incision with placebo in elective on-pump median sternotomy open cardiac surgery patients.
All patients will receive standard monitoring and catheterization. After anesthesia induction and before skin incision, patients will be assigned to the ketamine group or the control group. The ketamine group will receive 1 mg/kg intravenous ketamine; the control group will receive placebo normal saline.
In the postoperative period, all patients will receive cardiovascular management, ventilatory support, and extubation according to institutional ICU protocols. Per institutional protocol, postoperative analgesia will include IV paracetamol 1 g every 6 hours and tramadol infusion 300 mg/50 mL over 24 hours. For sedation and analgesia, a fentanyl infusion of 0.5-1.5 mcg/kg/hour will be titrated to maintain VAS < 5. Intravenous morphine 0.05 mg/kg will be used as rescue analgesia.
Ketamine group: 1 mg/kg IV ketamine after induction and before skin incision. Control group: Normal saline Study objective: To investigate the effect of a single intraoperative dose of ketamine on postoperative chronic pain, acute pain, and postoperative opioid requirements in patients undergoing open-heart surgery under general anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA II-III,
- •Patients scheduled for elective on-pump open cardiac surgery via median sternotomy.
Exclusion Criteria
- •Emergency surgery requirement
- •Need for reoperation
- •Requirement for postoperative re-intubation
- •History of opioid use
- •Preoperative diabetic neuropathy or autonomic dysfunction
- •Hepatic or renal dysfunction
- •History of neuropathic pain
- •Neurocognitive disorders such as psychosis or dementia
- •Use of antidepressants or antipsychotics
- •Body mass index (BMI) > 40
Outcomes
Primary Outcomes
Presence of postoperative chronic pain at 3 months
Time Frame: From the day of surgery through 6 months postoperatively.
Incidence of persistent postoperative pain at 3 months.
Presence of postoperative chronic pain at 6 months
Time Frame: From the day of surgery to 6 months postoperatively.
Incidence of persistent postoperative pain at 6 months.
Secondary Outcomes
- Pain scores (Numeric Rating Scale ) at extubation and at 0, 3, 6, 12, 24, and 48 hours post-extubation(Two days starting from the day of surgery the day of enrollment)
- Time to first rescue analgesic request(When the day of surgery is considered Day 1, it will be applied from the time the patient is admitted to the postoperative ICU until discharge from the ICU, for a maximum of 2 weeks.)
- ICU delirium assessed by CAM-ICU(When the day of surgery is considered Day 1, it will be applied daily from the time the patient is admitted to the postoperative ICU until discharge from the ICU, for a maximum of 2 weeks.)
- Quality of Recovery-15 (QoR-15)(When the day of surgery is considered Day 1, it will be applied on the day of hospital discharge, for a maximum of 4 weeks)
- Brief Pain Inventory-Short Form(The period from the day of surgery (day of enrollment) until 6 mounth.)
- Pain Self-Efficacy Questionnaire(The period from the day of surgery (day of enrollment) until 6 mounth.)
Investigators
eralp çevikkalp
Associate Professor
Bursa Sehir Hastanesi