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

Ain Shams University

Status: Not yet enrolling

Conditions: Laparoscopic Appendectomy; Pain Management; Anti Oxidative Stress

Treatments: Dietary Supplement: N Acetyl Cysteine; Other: Placebo; Dietary Supplement: Alpha-Lipoic Acid (ALA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07360379

HM000209

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65 years, either sex

  • ASA physical status I-III
  • Undergoing laparoscopic appendectomy
  • Able to provide informed consent and take oral medications postoperatively

Exclusion criteria

• 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

Exclusion Criteria:

-

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups, including a placebo group

N- acetyl cysteine

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: N Acetyl Cysteine

Alpha Lipoic acid

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Alpha-Lipoic Acid (ALA)

Placebo

Placebo Comparator group

Description:

Matching placebo capsules given at identical intervals.

Treatment:

Other: Placebo