Laparoscopic AppendectomyNCT07360379
Comparing N-Acetylcysteine (NAC) Versus Alpha-Lipoic Acid (ALA) as Adjuncts for Postoperative Pain Management After Laparoscopic Appendectomy
A study testing N Acetyl Cysteine and Alpha-Lipoic Acid (ALA) in people with Laparoscopic Appendectomy and Pain Management, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Appendectomy, Pain Management, Anti Oxidative Stress
- What is being tested?
- N Acetyl Cysteine and Alpha-Lipoic Acid (ALA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 28 Dec 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, either sex
- ASA physical status I-III
- Undergoing laparoscopic appendectomy
- Able to provide informed consent and take oral medications postoperatively
Who cannot join
- 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
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Being tested
- N Acetyl Cysteine, Alpha-Lipoic Acid (ALA), Placebo
- Keywords
- Postoperative pain, Laparoscopic appendectomy, N- acetyl cysteine, Alpha lipoic acid, pain management
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N Acetyl CysteineDietary 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.
PlaceboOther
Matching placebo capsules given at identical intervals.
| Study group | Role | What they receive |
|---|---|---|
| N- acetyl cysteine | Active comparator | Patients of this group will receive 600 mg oral N-acetylcysteine 1-2 hours preoperatively Receives: Dietary Supplement: N Acetyl Cysteine |
| Alpha Lipoic acid | Active comparator | Patients of this group will receive 600 mg oral Alpha lipoic acid 1-2 hours preoperatively Receives: Dietary Supplement: Alpha-Lipoic Acid (ALA) |
| Placebo | Placebo comparator | Matching placebo capsules given at identical intervals. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Pain intensity: VAS at 2, 6, 12, 24, and 48 hours post-surgery (0 = no pain, 10 = worst pain)
Measured: At 2 hours, 6 hours, 12 hours , 24 hours , and 48 hours post-surgery
Secondary outcomes (4)
Incidence of Nausea and vomiting
assessed on a 3-point scale (0 = none, 1 = mild, 2 = severe)
Measured: 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
Measured: 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.
Measured: 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
Measured: at baseline of the study and at 24 hours and 48 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start28 Dec 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic AppendectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed El Mokadem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360379
- Sponsor's protocol ID
- HM000209
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing N-Acetylcysteine (NAC) Versus Alpha-Lipoic Acid (ALA) as Adjuncts for Postoperative Pain Management After Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT07360379
- Acronym / sponsor ID
- HM000209
- Keywords
- Postoperative pain, Laparoscopic appendectomy, N- acetyl cysteine, Alpha lipoic acid, pain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Dec 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N- acetyl cysteine | Active comparator | Dietary Supplement: N Acetyl CysteinePatients of this group will receive 600 mg oral N-acetylcysteine 1-2 hours preoperatively |
| Alpha Lipoic acid | Active comparator | Dietary Supplement: Alpha-Lipoic Acid (ALA)Patients of this group will receive 600 mg oral Alpha lipoic acid 1-2 hours preoperatively |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo capsules given at identical intervals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years, either sex
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N Acetyl Cysteine600 mg oral N-acetylcysteine 1-2 hours preoperatively | Dietary supplement | N- acetyl cysteine |
| Alpha-Lipoic Acid (ALA)600 mg oral alpha-lipoic acid 1-2 hours preoperatively. | Dietary supplement | Alpha Lipoic acid |
| PlaceboMatching placebo capsules given at identical intervals. | Other | Placebo |
Primary outcome
Visual analogue scale (VAS)
Time frame: 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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing N Acetyl Cysteine and Alpha-Lipoic Acid (ALA) in people with Laparoscopic Appendectomy and Pain Management, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Elmokadem, PhD of clinical pharmacy (+201006242110, eman.abdelatif@fue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: At 2 hours, 6 hours, 12 hours , 24 hours , and 48 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.