Postoperative Pain Clinical Trial
Official title:
Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes
NCT number | NCT02765750 |
Other study ID # | 4659 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | March 2018 |
Verified date | June 2018 |
Source | 424 General Military Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. Group A and B patients will listen to a positive message under general anesthesia. Group C patients will not listen to the message. The postoperative pain, analgesic consumption and frequency of nausea, vomiting and emergence agitation episodes will be documented and compared between the 3 groups.
Status | Terminated |
Enrollment | 5 |
Est. completion date | March 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Laparoscopic cholecystectomy. - ASA 1-3 Exclusion Criteria: - Hearing loss. - Chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines) |
Country | Name | City | State |
---|---|---|---|
Greece | 424 Army General Hospital Department of Anesthesia | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
424 General Military Hospital |
Greece,
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* Note: There are 82 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity. | The patients will be asked to evaluate their postoperative pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain). Pain will be evaluated in supine position, after cough and after change of position from supine to standing. | Within an average of 15 minutes after emergence from general anesthesia. | |
Primary | Postoperative paracetamol consumption. | The patients will be instructed to ask for analgesics as needed. When rescue analgesia is required 1000mg paracetamol will be administered. The frequency of paracetamol administration will be documented. | 24 hours after emergence from general anesthesia. | |
Primary | Postoperative tramadol consumption. | If the administration of paracetamol doesn't relieve postoperative pain and the patients continues to ask for analgesia, 100mg tramadol will be administered. The frequency of tramadol administration will be documented. | 24 hours after emergence from general anesthesia. | |
Primary | Emergence agitation (yes/no). | The patients' mental status will be evaluated with the 7grade Riker's Agitation-Sedation Scale. If the patient has a score of 5 or greater he will be documented as a case of emergence agitation. | Within an average of 10 minutes after emergence from general anesthesia. | |
Primary | Postoperative nausea. | The frequency of episodes of nausea will be documented. | 24 hours after emergence from general anesthesia. | |
Primary | Postoperative vomiting. | The frequency of episodes of vomiting will be documented. | 24 hours after emergence from general anesthesia. | |
Primary | Pain Intensity. | The patients will be asked to evaluate their postoperative pain by using the 11 grade Numerical Rating Scale (0 no pain, 10 maximum possible pain). Pain will be evaluated in supine position, after cough and after change of position from supine to standing. | 1 hour after the end of surgery. | |
Primary | Pain Intensity. | Numerical Rating Scale (0 no pain, 10 maximum possible pain). Pain will be evaluated in supine position, after cough and after change of position from supine to standing. | 6 hours after the end of surgery. | |
Primary | Pain Intensity. | Numerical Rating Scale (0 no pain, 10 maximum possible pain). Pain will be evaluated in supine position, after cough and after change of position from supine to standing. | 12 hours after the end of surgery. | |
Primary | Pain Intensity. | Numerical Rating Scale (0 no pain, 10 maximum possible pain). Pain will be evaluated in supine position, after cough and after change of position from supine to standing. | 24 hours after the end of surgery. | |
Secondary | Explicit memory. | The patient will be asked to answer the modified Brice questionnaire in order to investigate for explicit memory of the intraoperative message or other events. | 24 hours after emergence from general anesthesia. |
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