Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Postoperative Pain Clinical Trial

Official title:

Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639741
• Other study ID #: HZLTNS99
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2021
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery.

Description:

The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery. One hundred-sixty five ASA I-II adult patients between 18-65 years of age, undergoing elective major abdominal surgery with general anesthesia will be included in this double blinded, randomised, controlled study. Patients will randomly divided into equal (n=55) three groups. Preoperatively, one hour before surgery, patients will receive melatonin (6 mg) in group M, vitamin C (2 gr) in group C or placebo tablet in group P orally. A standard anesthetic protocol will be administered to all patients. At the end of surgery, postoperative pain control will be provided via a patient controlled analgesia (PCA) device including morphine in all groups. Hemodynamic parameters, pain, sedation, patient satisfaction, total morphine consumption, supplement analgesic requirement, incidence of nausea and vomiting and other side effects will be recorded at 5, 10, 30 min and 1, 2, 4, 6, 8, 12, 24 hr after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 30, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patients undergoing elective major abdominal surgery with general anesthesia

Exclusion Criteria:

A history of psychiatric disorders, chronic pain syndromes, obstructive sleep apnea, severe asthma, chronic obstructive pulmonary disease, congestive heart failure, hepatic or renal failure, patients with pregnancy or in lactation period or a history of allergic reaction to any drugs

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Melatonin
Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
• Vitamin C
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated

Other:
• Placebo
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated

Locations

Country	Name	City	State
Turkey	Hakki Ünlügenç	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption at 24 hours after surgery.)		24 hour