PCA Ketamine-Morphine Versus PCA Morphine as Post-Operative Analgesia in Colorectal Surgery.

JEP-2018-092

The goal of this clinical trial is to compare the effectiveness of PCA ketamine-morphine versus conventional PCA morphine in postoperative patients undergoing elective laparotomy colorectal surgery under general anaesthesia. The specific objectives are: 1. To compare the postoperative analgesic requirement with PCA ketamine-morphine in comparison with PCA morphine. 2. To compare the postoperative pain scores between PCA ketamine-morphine and PCA morphine. 3. To assess patients' overall satisfaction with PCA ketamine-morphine in comparison with PCA morphine. 4. To study the incidence of side effects of PCA ketamine-morphine in comparison with PCA morphine. Participants will be screened and recruited at the pre-anaesthetic clinic (PAC). Those who consented will be taught to use the PCA machine and the potential side effects of the study drugs. They will be randomly allocated into either Group A or Group B by computer-generated randomization a day before planned surgery. Researchers will compare Group A and Group B to see post-operative pain scores, patients' overall satisfaction and any incidence of side effects.

2018-04-05

2019-04-04

2019-04-04

Completed

Early phase I

60

Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) I or II patients. 2. Patients between 18- 70 years of age. 3. Patients undergoing elective laparotomy colorectal surgery. Exclusion Criteria: 1. Patients with a known allergy to morphine or ketamine. 2. Patients with uncontrolled hypertension. 3. Patients with a past history of chronic pain on regular analgesics. 4. Patients on psychiatric drugs. 5. Patients with BMI more than 35. 6. Patients with Creatinine Clearance \< 30

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly allocated into either Group A or Group B by computer-generated randomization a day before planned surgery.\n\nGroup A will receive PCA ketamine-morphine 0.5 mg/ml in 1:1 ratio while group B will receive PCA morphine 1mg/ml.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "The patients, nurses who cared for the patients, the anesthetist who performed the anesthesia and the investigators who gathered the data were blinded to patients' group allocation.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-08-24