Effect of Preoperative Oral Melatonin Versus Gabapentin on Rebound Pain and Perioperative Anxiety with a Single-Shot Inferior Alveolar Nerve Block for Unilateral Mandibulectomy Cancer Surgery

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202502833693256

Enrollment

Registered

2025-02-10

Start date

2025-01-30

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Anaesthesia

Interventions

Melatonin Group

Gabapentin Group 90 minutes before surgery.

Placebo Group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.All patients between 18 and 75 years. 2. American Society of Anesthesiologists physical status (ASA) I and II. 3. patients scheduled for elective maxillofacial cancer surgery requiring unilateral mandibular resection.

Exclusion criteria

Exclusion criteria: 1.Patients with allergy to melatonin, gabapentin, or local anesthetics. 2.pre- existing sleep disorders, psychiatric illness, or substance abuse, severe renal or hepatic dysfunction. 3. Pregnant or breastfeeding individuals. 4. patients with surgery involving upper alveolar/ maxillary resection. 5. body mass index (BMI) below 18 kg/m2 and above 30 kg/m2. 5. ongoing opioid therapy.

Design outcomes

Primary

Measure	Time frame
Prevalence of postoperative rebound pain of any severity (visual analog scale (VAS) >0 on a 0 - 10 scale as 0 = no pain, 10 = the worst possible pain) at , 6 hours,12h and 24 h after surgery in unilateral mandibulectomy cancer surgery.	—

Secondary

Measure	Time frame
1. Postoperative first 24-h opioid consumption. 2. Anxiety score measured using a 10-point Verbal Anxiety Score (VAS) ranging from 0 to 10 (0 = completely calm, 10 = the worst possible anxiety) at 15 min before surgery and 1, 2, 6, 12, and 24 hours postoperatively. 3. The amount of fentanyl used during mandibulectomy resection. 4. duration of analgesia provided by each preoperative medication. 5. Incidence of postoperative nausea, vomiting and dizziness. 6. Quality of recovery assessed 24 h after surgery using the qor-15 questionnaire. 7. Patient satisfaction with pain management assessed 24 h after surgery using an 11-point Likert scale (range, 0–10: 0, entirely unsatisfied; 10,fully satisfied).	—

Measure

Time frame

1. Postoperative first 24-h opioid consumption. 2. Anxiety score measured using a 10-point Verbal Anxiety Score (VAS) ranging from 0 to 10 (0 = completely calm, 10 = the worst possible anxiety) at 15 min before surgery and 1, 2, 6, 12, and 24 hours postoperatively. 3. The amount of fentanyl used during mandibulectomy resection. 4. duration of analgesia provided by each preoperative medication. 5. Incidence of postoperative nausea, vomiting and dizziness. 6. Quality of recovery assessed 24 h after surgery using the qor-15 questionnaire. 7. Patient satisfaction with pain management assessed 24 h after surgery using an 11-point Likert scale (range, 0–10: 0, entirely unsatisfied; 10,fully satisfied).

—

Countries

Egypt

Contacts

Public ContactMahmoud Attia

Lecturer of Anesthesia

Drmahmoudhassan@mans.edu.eg201006192325

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026