Chronic Pain Clinical Trial
Official title:
Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial
Verified date | February 2024 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy
Status | Completed |
Enrollment | 60 |
Est. completion date | January 26, 2024 |
Est. primary completion date | January 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 18-75 years. - Both sexes. - ASA (American Society of Anesthesiology) physical status II-III. - Scheduled for open thoracotomy. Exclusion Criteria: - Contraindications to or failed paravertebral block . - Body mass index (BMI) >35 kg/m2. - The likelihood of postoperative mechanical ventilation. - Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol, or recreational drug addiction. - Hypersensitivity to ketamine or levobupivacaine. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | El-Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first analgesia | The time till the first rescue of analgesia of morphine. Patients can receive incremental doses of morphine 3 mg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3. | 24 hour postoperatively | |
Secondary | Total amount of morphine consumption | The total morphine consumption in the 1st 24h postoperative will be recorded. Patients can receive incremental doses of meperidine 0.5 mg/kg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3. | 24 hour postoperatively | |
Secondary | Pain intensity during rest | Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative. | 48 hour postoperatively | |
Secondary | Pain intensity during deep breathing | Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative. | 48 hour postoperatively | |
Secondary | Incidence of chronic pain | The neuropathic PTPS cases were screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS with a neuropathic component were grade 2 (probable) or 3 (definite), that is, GSNP =2 | three months postoperatively |
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