Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Melatonin; Drug: Vitamin C; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Hakkı Unlugenc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oral Melatonin Tablet; Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia.	Drug: Melatonin; Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated; Other Names: Melatonina 3 mg tb,; Drug: Vitamin C; Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated; Other Names: Vitamin C 1000 mg tb; Other: Placebo; Preoperative placebo tablet will be given and postoperative pain scores will be evaluated; Other Names: Placebo tb
ACTIVE_COMPARATOR: Oral Vitamin C Tablet; Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia.	Drug: Melatonin; Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated; Other Names: Melatonina 3 mg tb,; Drug: Vitamin C; Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated; Other Names: Vitamin C 1000 mg tb; Other: Placebo; Preoperative placebo tablet will be given and postoperative pain scores will be evaluated; Other Names: Placebo tb
PLACEBO_COMPARATOR: Oral Placebo Tablet; Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.	Drug: Melatonin; Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated; Other Names: Melatonina 3 mg tb,; Drug: Vitamin C; Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated; Other Names: Vitamin C 1000 mg tb; Other: Placebo; Preoperative placebo tablet will be given and postoperative pain scores will be evaluated; Other Names: Placebo tb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
morphine consumption at 24 hours after surgery.)	24 hour

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Study Director: Hakkı Ünlügenç, Prof Dr., Çukurova University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (ESTIMATE): December 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Melatonin; Vitamin C; Morphine consumption
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Micronutrients; Antioxidants; Melatonin; Vitamins; Ascorbic Acid
• Other Study ID Numbers: HZLTNS99

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO