Comparing N-Acetylcysteine (NAC) Versus Alpha-Lipoic Acid (ALA) as Adjuncts for Postoperative Pain Management After Laparoscopic Appendectomy

NCT07360379 | Not Yet Recruiting

• 1 other identifier: HM000209
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pain remains a major concern following laparoscopic appendectomy, despite advances in minimally invasive surgery and multimodal analgesia. Inadequate pain control delays recovery, prolongs hospital stay, and increases opioid consumption with associated adverse effects. Therefore, identifying safe adjunct therapies that enhance analgesia and reduce opioid requirements is an important clinical goal. Oxidative stress and inflammation play a critical role in the development and maintenance of postoperative pain. Surgical trauma induces the generation of reactive oxygen species, which sensitize peripheral nociceptors and enhance central pain transmission. Antioxidants capable of modulating oxidative stress and inflammatory pathways may therefore offer analgesic benefits beyond conventional analgesics. N-Acetylcysteine (NAC), a glutathione precursor, has demonstrated anti-inflammatory and analgesic properties in both experimental and clinical settings. It reduces oxidative stress, improves microcirculation, and modulates nociceptive signaling. Alpha-Lipoic Acid (ALA) is another potent antioxidant that acts as a cofactor in mitochondrial metabolism and has proven efficacy in neuropathic pain conditions. However, its role in acute postoperative pain has not been fully investigated. To our knowledge, no clinical trial has directly compared NAC and ALA in the perioperative setting, and their effects following laparoscopic appendectomy remain unstudied. This randomized controlled trial aims to evaluate the efficacy and safety of NAC and ALA as adjuncts to standard analgesia, with the goal of estimating their effect on postoperative opioid consumption and pain intensity. The results will provide preliminary data to guide larger definitive studies. Aim of the study The aim of this study is to evaluate and compare the efficacy and safety of N-acetylcysteine (NAC) and alpha-lipoic acid (ALA) as adjuncts to standard postoperative analgesia in patients undergoing laparoscopic appendectomy. Specifically, the study seeks to determine their effects on postoperative pain intensity, opioid consumption, and recovery profile in the early postoperative period.

Conditions

Pain Management; Anti Oxidative Stress; Laparoscopic Appendectomy

Keywords

Postoperative pain; Laparoscopic appendectomy; N- acetyl cysteine; Alpha lipoic acid; pain management

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS)

  Pain intensity: VAS at 2, 6, 12, 24, and 48 hours post-surgery (0 = no pain, 10 = worst pain)

  At 2 hours, 6 hours, 12 hours , 24 hours , and 48 hours post-surgery

Secondary Outcomes (4)

• Incidence of Nausea and vomiting

  Assessed at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours post-surgery

• Rescue analgesia

  in 24 and 48 hours post surgery

• Occurrence of Adverse effects

  Occurrence of adverse effects will be assessed at baseline of the study and at 24 hours and 48 hours post surgery.

• Total opioid use

  at baseline of the study and at 24 hours and 48 hours post surgery

Study Arms (3)

N- acetyl cysteine

ACTIVE COMPARATOR

Patients of this group will receive 600 mg oral N-acetylcysteine 1-2 hours preoperatively

Dietary Supplement: N Acetyl Cysteine

Alpha Lipoic acid

ACTIVE COMPARATOR

Patients of this group will receive 600 mg oral Alpha lipoic acid 1-2 hours preoperatively

Dietary Supplement: Alpha-Lipoic Acid (ALA)

Placebo

PLACEBO COMPARATOR

Matching placebo capsules given at identical intervals.

Other: Placebo

Interventions

Alpha-Lipoic Acid (ALA) DIETARY_SUPPLEMENT

600 mg oral alpha-lipoic acid 1-2 hours preoperatively.

Alpha Lipoic acid

N Acetyl Cysteine DIETARY_SUPPLEMENT

600 mg oral N-acetylcysteine 1-2 hours preoperatively

N- acetyl cysteine

Placebo OTHER

Matching placebo capsules given at identical intervals.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years, either sex
• ASA physical status I-III
• Undergoing laparoscopic appendectomy
• Able to provide informed consent and take oral medications postoperatively

You may not qualify if:

• Chronic opioid use or chronic pain disorder
• Pregnancy or lactation
• Hepatic or renal impairment
• Known hypersensitivity to NAC or ALA
• Complicated appendicitis requiring open surgery or ICU admission

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Acetylcysteine; Thioctic Acid

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Carboxylic Acids; Thiophenes; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Central Study Contacts

Eman Elmokadem, PhD of clinical pharmacy

CONTACT

+201006242110; eman.abdelatif@fue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 22, 2026
• Study Start: December 28, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01