Laparoscopic Appendectomy, Pain Management, Anti Oxidative Stress
Conditions
Keywords
Postoperative pain, Laparoscopic appendectomy, N- acetyl cysteine, Alpha lipoic acid, pain management
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.
Interventions
DIETARY_SUPPLEMENTN Acetyl Cysteine
600 mg oral N-acetylcysteine 1-2 hours preoperatively
DIETARY_SUPPLEMENTAlpha-Lipoic Acid (ALA)
600 mg oral alpha-lipoic acid 1-2 hours preoperatively.
OTHERPlacebo
Matching placebo capsules given at identical intervals.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) | At 2 hours, 6 hours, 12 hours , 24 hours , and 48 hours post-surgery | Pain intensity: VAS at 2, 6, 12, 24, and 48 hours post-surgery (0 = no pain, 10 = worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Nausea and vomiting | Assessed at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours post-surgery | assessed on a 3-point scale (0 = none, 1 = mild, 2 = severe) |
| Rescue analgesia | in 24 and 48 hours post surgery | time to first opioid request will be assessed |
| 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. | Occurrence of adverse effects like dizziness, headache, rash, or gastrointestinal discomfort will be recorded and graded for severity. |
| Total opioid use | at baseline of the study and at 24 hours and 48 hours post surgery | Total opioid use will be assessed throughout the study period |
Contacts
CONTACTEman Elmokadem, PhD of clinical pharmacy
Outcome results
None listed