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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years, either sex

ASA physical status I-III

Undergoing laparoscopic appendectomy

Able to provide informed consent and take oral medications postoperatively

Disqualifiers

Chronic opioid use or chronic pain disorder

Pregnancy or lactation

Hepatic or renal impairment

Known hypersensitivity to NAC or ALA

Trial design

Design model

Parallel

Treatments tested in this trial

  • N Acetyl Cysteine

    Dietary supplement

    600 mg oral N-acetylcysteine 1-2 hours preoperatively

  • Alpha-Lipoic Acid (ALA)

    Dietary supplement

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

  • Placebo

    Other intervention

    Matching placebo capsules given at identical intervals.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: N- acetyl cysteineActive comparator 1 intervention
Group B: Alpha Lipoic acidActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

Incidence of Nausea and vomiting

assessed on a 3-point scale (0 = none, 1 = mild, 2 = severe)

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

Rescue analgesia

time to first opioid request will be assessed

Time frame
in 24 and 48 hours post surgery
3

Occurrence of Adverse effects

Occurrence of adverse effects like dizziness, headache, rash, or gastrointestinal discomfort will be recorded and graded for severity.

Time frame
Occurrence of adverse effects will be assessed at baseline of the study and at 24 hours and 48 hours post surgery.
4

Total opioid use

Total opioid use will be assessed throughout the study period

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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