Pain Clinical Trial
Official title:
Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours
Verified date | March 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia.
Status | Completed |
Enrollment | 176 |
Est. completion date | August 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 60 years. - Both sexes. - American Society of Anesthesiologists (ASA) physical status I or II . - Patient undergoing mandibular or oral cavity tumour resection. - Body mass index (BMI) between 18.5-24.9. - Patient with serum albumen above 3 gm. - Patient with written valid consent Exclusion Criteria: - Patient refusal and uncooperative patients. - Patient ASA III or IV. - Age more than 60 or less than 18. - Serum albumen less than 3. - Pre-existing severe malnourishment. - Allergy to test drugs. - Patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and NSAID. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of wound infection | Evidence of redness and tenderness of surgical wound with discharge of pus was defined as a wound infection. | 28 days after intervention | |
Secondary | Fistula formation | Fistula formation was measured postoperatively. | 28 days after intervention | |
Secondary | Length of hospital stay | Length of hospital stay was measured from admission discharge from hospital | 28 days after intervention | |
Secondary | Total dose of intraoperative opioids | Total dose of intraoperative opioids was calculated in either group | Intraoperative | |
Secondary | Total dose of postoperative opioids | Total dose of postoperative opioids was calculated in either group | 12 hours postoperative | |
Secondary | Degree of pain | Postoperative pain will be assessed by visual analogue scale (VAS) every 4 h. for 12 h. Patients reporting VAS score (more than 3) will receive rescue analgesics. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). | 12 hours postoperative | |
Secondary | The incidence of mortality | Mortality was measured postoperatively | 28 days after intervention | |
Secondary | The incidence of complications | Postoperative complications as urinary tract infection (UTI)and pneumonia. | 12 hours postoperative |
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