Comparing N-Acetylcysteine (NAC) Versus Alpha-Lipoic Acid (ALA) as Adjuncts for Postoperative Pain Management After Laparoscopic Appendectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: N Acetyl Cysteine, Alpha-Lipoic Acid (ALA), Placebo.
- Who it may be relevant to
- Registry conditions: Laparoscopic Appendectomy, Pain Management, Anti Oxidative Stress. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement N Acetyl Cysteine
600 mg oral N-acetylcysteine 1-2 hours preoperatively - Dietary supplement Alpha-Lipoic Acid (ALA)
600 mg oral alpha-lipoic acid 1-2 hours preoperatively. - Other Placebo
Matching placebo capsules given at identical intervals.
Primary outcome measures
- Visual analogue scale (VAS) [Time frame: At 2 hours, 6 hours, 12 hours , 24 hours , and 48 hours post-surgery]
Secondary outcome measures (4)
- Incidence of Nausea and vomiting [Time frame: Assessed at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours post-surgery]
- Rescue analgesia [Time frame: in 24 and 48 hours post surgery]
- Occurrence of Adverse effects [Time frame: Occurrence of adverse effects will be assessed at baseline of the study and at 24 hours and 48 hours post surgery.]
- Total opioid use [Time frame: at baseline of the study and at 24 hours and 48 hours post surgery]
Eligibility criteria
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07360379 · HM000209