Effect of Melatonin on Postoperative Pain After Simple Nephrectomy

NCT06872944 | Completed Early Phase 1 DMC

• 1 other identifier: melatonin in nephrectomy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to evaluate the role of melatonin in the management of postoperative pain in patients undergoing simple nephrectomy regarding:

• Pain score (VAS).
• Total Morphine consumption is 1st 24 hr.
• Time to the 1st rescue analgesia.
• Intra-operative and post-operative hemodynamics.
• Anxiety.
• Patient satisfaction.
• Adverse events.

Conditions

Pain Score (VAS) at 24 h Postoperatively

Outcome Measures

Primary Outcomes (1)

• Pain score (VAS) at 24 h postoperatively

  A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 3 mg bolus if the VAS \> 3 to be repeated after 30 min if pain persists until the VAS \< 4. VAS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24 h postoperatively.

  24 hours postoperative

Secondary Outcomes (3)

• Time to the 1st rescue analgesia

  (time from end of surgery to first dose of morphine administrated 24 hours postoperative.

• Total Morphine consumption is 1st 24 hr (mg).

  24 hours postoperative

• Degree of patient satisfaction

  24 hours postoperative

Study Arms (2)

Group M

EXPERIMENTAL

Patients will receive 4 mg of prolonged-release formulation of oral melatonin at the night (8 PM) before the procedure and another dose 2 hours before surgery.

Drug: Melatonin

Group C

PLACEBO COMPARATOR

Patients will receive sugar coated tablets at the night (8 PM) before the procedure and another dose 2 hours before surgery.

Drug: Sugar Coated Tablet

Interventions

Melatonin DRUG

Melatonin, or N-acetylmethoxytryptamine, is a hormone secreted by the pineal gland in the brain. Light is the main factor that regulates melatonin production. Melatonin has important biological effects on the body and plays an important role in regulating the sleep wake cycle. Besides circadian rhythm stabilizing, exogenous melatonin has been investigated for other effects such as modulation of blood pressure, body temperature and cortisol control, immune function, and anti-oxidative defense. Recent studies showed some benefits of perioperative short-acting melatonin in different groups of patients such as quality of recovery after surgery, diminished depressive symptoms and pain score reduction

Group M

Sugar Coated Tablet DRUG

sugar coated tablets will be given to the patients at the night (8 PM) before the procedure and another dose 2 hours before surgery

Also known as: placebo

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• (ASA) physical status I, II.
• Patients undergoing simple nephrectomy.

You may not qualify if:

• Patient refusal.
• Patients with a history of allergic reactions to melatonin.
• Patients receiving drugs with known analgesic and sedative properties.
• Body Mass Index (BMI) over 30 kg/m2.
• Drug or alcohol abuse.
• History of cardiovascular disease.
• Renal Failure.
• Mental impairment.
• Renal impairment.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Medicine-Cairo Univeristy

Cairo, 11562, Egypt

Location

Faculty of Medicine- Cairo University

Cairo, 11956, Egypt

Location

Related Publications (5)

• Bonmati-Carrion MA, Rol MA. Melatonin as a Mediator of the Gut Microbiota-Host Interaction: Implications for Health and Disease. Antioxidants (Basel). 2023 Dec 23;13(1):34. doi: 10.3390/antiox13010034.

  PMID: 38247459 BACKGROUND

• Kiabi FH, Emadi SA, Jamkhaneh AE, Aezzi G, Ahmadi NS. Effects of preoperative melatonin on postoperative pain following cesarean section: A randomized clinical trial. Ann Med Surg (Lond). 2021 May 12;66:102345. doi: 10.1016/j.amsu.2021.102345. eCollection 2021 Jun.

  PMID: 34040762 BACKGROUND

• Andersen LP. The analgesic effects of exogenous melatonin in humans. Dan Med J. 2016 Oct;63(10):B5289.

  PMID: 27697139 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Chen Q, Beal EW, Okunrintemi V, Cerier E, Paredes A, Sun S, Olsen G, Pawlik TM. The Association Between Patient Satisfaction and Patient-Reported Health Outcomes. J Patient Exp. 2019 Sep;6(3):201-209. doi: 10.1177/2374373518795414. Epub 2018 Aug 27.

  PMID: 31535008 BACKGROUND

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia-faculty of medicine

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: March 21, 2025
• Primary Completion: June 21, 2025
• Study Completion: July 7, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

EG (2)