Postoperative Pain Clinical Trial
Official title:
Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. A Randomized Double-blind Study
The goal of this clinical trial is to compare the analgesic effect of melatonin, and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours e.g. radical cystectomy, radical prostatectomy, colectomy, sigmoidectomy, splenectomy, and CBD exploration through mid-line incision. This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause: - More reduction in total morphine consumption in the first 24 hours postoperatively - More reduction of the incidence of chronic post-surgical pain, than using each adjuvant alone. Participants will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration; 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group. Researchers will compare: - The effect of melatonin, vitamin C, and their combination on postoperative opioid consumption - The severity of postoperative pain, using the Numerical Rating Scale (NRS) - Patients' satisfaction with a three-point scale - The time of the first requirement for rescue analgesia - The effect on the incidence of chronic post-surgical pain.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 10, 2024 |
Est. primary completion date | June 27, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - ASA I -II - Expected time of operation 3-5 hours Exclusion Criteria: - BMI > 35 kg/m2 - Presence of psychiatric or mental disorders. - Chronic pain syndromes (neuropathic pain, post-herpetic neuralgia, Complex regional pain syndrome) - Drug or alcohol abuse. - Hepatic failure (Child class B- Child class C) - Renal impairment (creatinine > 2mg/dL or CKD on regular dialysis) - History of any allergic reaction to the drugs used in the study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine - Cairo University | Cairo | Manial |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Theodor Bilharz Research Institute |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total morphine consumption | mg | The 1st 24 postoperative hours | |
Secondary | Numeric Rating Scale | Pain will be classified as mild (NRS 0-4), moderate (NRS 5-7), and severe (NRS 8-10) | 5 minutes after extubation, 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, one month and three months | |
Secondary | Richmond Agitation Sedation Scale | (-5) Unarousable, (-4) Deep sedation, (-3) Moderate sedation, (-2) Light sedation, (-1) Drowsy, (0) Alert and calm, (+1) Restless, (+2) Agitated, (+3) Very agitation, and (+4) Combative | 5 minutes after extubation, 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours | |
Secondary | Time to first analgesic request | minutes | from the time of end of surgery till the first analgesic requirement during the 24 hours postoperative | |
Secondary | chronic post-surgical pain | present or not present | 3 months | |
Secondary | patient satisfaction using Likert three-point scale | good, moderate, or bad | 24 hours, 48 hours, 72 hours, 96 hours, one month and three months postoperative | |
Secondary | systolic blood pressure | mmHg | every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively. | |
Secondary | Heart rate | beat per minute | every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively. | |
Secondary | Intra-operative mean consumption of sevoflurane per hour. | ml per hour | from the start of anesthesia till the end of anesthesia |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT03181620 -
Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Recruiting |
NCT06007378 -
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
|
N/A | |
Recruiting |
NCT05943015 -
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
|
N/A | |
Completed |
NCT04544228 -
Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
|
N/A | |
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03663478 -
Continuous TQL Block for Elective Cesarean Section
|
Phase 4 | |
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Completed |
NCT05170477 -
Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment
|
N/A | |
Not yet recruiting |
NCT04561856 -
Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone
|
Phase 4 | |
Completed |
NCT06425601 -
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
|
N/A | |
Completed |
NCT03612947 -
TAP Block in Laparoscopic Cholecystectomy.
|
Phase 2 | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
Active, not recruiting |
NCT04190355 -
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
|
N/A | |
Recruiting |
NCT05145153 -
Incidence of Chronic Pain After Thoracic Surgery
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |