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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
N Acetyl Cysteine
Dietary supplement600 mg oral N-acetylcysteine 1-2 hours preoperatively
Alpha-Lipoic Acid (ALA)
Dietary supplement600 mg oral alpha-lipoic acid 1-2 hours preoperatively.
Placebo
Other interventionMatching placebo capsules given at identical intervals.
Treatment groups
Trial outcomes
Primary outcomes
Visual analogue scale (VAS)
Pain intensity: VAS at 2, 6, 12, 24, and 48 hours post-surgery (0 = no pain, 10 = worst pain)
Secondary outcomes
Incidence of Nausea and vomiting
assessed on a 3-point scale (0 = none, 1 = mild, 2 = severe)
Rescue analgesia
time to first opioid request will be assessed
Occurrence of Adverse effects
Occurrence of adverse effects like dizziness, headache, rash, or gastrointestinal discomfort will be recorded and graded for severity.
Total opioid use
Total opioid use will be assessed throughout the study period
Locations
Sponsors and contacts
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