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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N- acetyl cysteine | Active Comparator | Patients of this group will receive 600 mg oral N-acetylcysteine 1-2 hours preoperatively |
|
| Alpha Lipoic acid | Active Comparator | Patients of this group will receive 600 mg oral Alpha lipoic acid 1-2 hours preoperatively |
|
| Placebo | Placebo Comparator | Matching placebo capsules given at identical intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N Acetyl Cysteine | Dietary Supplement | 600 mg oral N-acetylcysteine 1-2 hours preoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (VAS) | Pain intensity: VAS at 2, 6, 12, 24, and 48 hours post-surgery (0 = no pain, 10 = worst pain) | At 2 hours, 6 hours, 12 hours , 24 hours , and 48 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea and vomiting | assessed on a 3-point scale (0 = none, 1 = mild, 2 = severe) | Assessed at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours post-surgery |
| Rescue analgesia | time to first opioid request will be assessed |
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Inclusion Criteria:
Age 18-65 years, either sex
Exclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman Elmokadem, PhD of clinical pharmacy | Contact | +201006242110 | eman.abdelatif@fue.edu.eg |
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| Alpha-Lipoic Acid (ALA) | Dietary Supplement | 600 mg oral alpha-lipoic acid 1-2 hours preoperatively. |
|
| Placebo | Other | Matching placebo capsules given at identical intervals. |
|
| in 24 and 48 hours post surgery |
| Occurrence of Adverse effects | Occurrence of adverse effects like dizziness, headache, rash, or gastrointestinal discomfort will be recorded and graded for severity. | Occurrence of adverse effects will be assessed at baseline of the study and at 24 hours and 48 hours post surgery. |
| Total opioid use | Total opioid use will be assessed throughout the study period | at baseline of the study and at 24 hours and 48 hours post surgery |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002264 | Carboxylic Acids |
| D013876 | Thiophenes |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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