Postoperative Fatigue SyndromeLIDO-TAPPNCT07612839
Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair
A study testing Lidocaine and 0.9 % sodium chloride in people with Postoperative Fatigue Syndrome and Inguinal Hernia Unilateral, run by Hakan Emirkadı at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized placebo-controlled trial aims to evaluate the effect of perioperative intravenous lidocaine on postoperative fatigue in patients undergoing elective laparoscopic TAPP inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Fatigue Syndrome, Inguinal Hernia Unilateral
- What is being tested?
- Lidocaine and 0.9 % sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2026to 31 Jan 2027
- 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 to 65 years
- Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair
- American Society of Anesthesiologists (ASA) physical status I or II
- Able to understand and complete the Multidimensional Fatigue Inventory-20 (MFI-20)
- Written informed consent provided
Who cannot join
- Known allergy or hypersensitivity to lidocaine or other amide-type local anesthetics
- Clinically significant hepatic or renal dysfunction
- Clinically significant cardiac rhythm or conduction disorder
- Chronic opioid use
- Regular use of antiarrhythmic medication
- Pregnancy or breastfeeding
- Planned use of an additional local anesthetic technique during the study intervention
- Inability to complete the study assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Istanbul, 34668
Hakan Emirkadı, MD, +905322609367, hemirkadi@gmail.com
About this study
Official title: The Effect of Intravenous Lidocaine on Postoperative Fatigue Syndrome in Patients Undergoing Elective Laparoscopic TAPP Inguinal Hernia Repair
This prospective randomized placebo-controlled trial aims to evaluate the effect of perioperative intravenous lidocaine on postoperative fatigue in patients undergoing elective laparoscopic TAPP inguinal hernia repair. Participants will be randomly assigned to receive either intravenous lidocaine or an equal-volume 0.9% sodium chloride placebo. The primary outcome is postoperative physical fatigue assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20). Secondary outcomes include postoperative pain, cumulative tramadol consumption, postoperative nausea and vomiting, and the requirement for additional analgesia.
Read the detailed description
Postoperative fatigue may negatively affect recovery after surgery. Intravenous lidocaine has analgesic, anti-inflammatory, and opioid-sparing properties that may influence postoperative recovery.
This prospective randomized placebo-controlled trial will include adult patients undergoing elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair under general anesthesia. Eligible participants will be randomly allocated to receive either perioperative intravenous lidocaine or an equal-volume 0.9% sodium chloride placebo according to the same administration schedule. Participants, anesthesia care providers, and postoperative outcome assessors will be blinded to treatment allocation.
The primary outcome is postoperative physical fatigue assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20), with a preoperative baseline assessment and postoperative assessments on days 1, 3, 5, and 7. Secondary outcomes include postoperative pain intensity, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and the requirement for additional analgesia during the first 24 postoperative hours.
- Being tested
- Lidocaine, 0.9 % sodium chloride
- Keywords
- Intravenous Lidocaine, Postoperative Fatigue, Laparoscopic TAPP Repair, Postoperative Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair.
0.9 % sodium chlorideDrug
0.9% sodium chloride will be administered intravenously as placebo in an equal volume and according to the same timing and infusion protocol as the lidocaine intervention.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Participants in this group will receive intravenous lidocaine based on ideal body weight. A loading dose of 1.5 mg/kg will be administered intravenously over 10 minutes before surgery, followed by a continuous infusion of 1.5 mg/kg/hour until the end of surgery. The infusion will be discontinued if signs suggestive of local anesthetic systemic toxicity or clinically significant unexplained hemodynamic or cardiac conduction abnormalities occur. Receives: Drug: Lidocaine |
| Control Group | Placebo comparator | Participants in this group will receive an equal-volume 0.9% sodium chloride placebo administered according to the same timing and infusion protocol as the lidocaine group. Standard perioperative care will otherwise be identical between groups. Receives: Drug: 0.9 % sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
MFI-20 Physical Fatigue Subscale Score
Postoperative physical fatigue will be assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20). The Physical Fatigue subscale consists of four items and ranges from 4 to 20 points, with higher scores indicating greater physical fatigue. A preoperative assessment will be obtained as the baseline value. Postoperative assessments will be performed on postoperative days 1, 3, 5, and 7.
Measured: Preoperative baseline and postoperative days 1, 3, 5, and 7
Secondary outcomes (4)
Postoperative Pain Intensity (11-point Numeric Rating Scale)
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Measured: 2, 4, 6, 12, and 24 hours after surgery and postoperative days 3, 5, and 7
Postoperative Nausea and Vomiting Within 24 Hours
Postoperative nausea and vomiting (PONV) will be assessed during the first 24 hours after surgery. The occurrence of nausea and vomiting will be recorded separately, and the occurrence of either nausea or vomiting will be considered PONV.
Measured: First 24 hours after surgery
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
Total tramadol consumption delivered through patient-controlled analgesia (PCA) during the first 24 hours after surgery will be recorded in milligrams. Higher values indicate greater postoperative opioid requirement.
Measured: First 24 hours after surgery
Requirement for Additional Analgesia During the First 24 Postoperative Hours
The requirement for additional analgesia with intravenous paracetamol during the first 24 hours after surgery will be recorded. The number and proportion of participants requiring at least one dose of additional analgesia will be compared between groups.
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start2 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Fatigue SyndromeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intravenous lidocaine group or the control group in a parallel-group design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hakan Emirkadı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakan Emirkadı, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612839
- Sponsor's protocol ID
- 25-42
- Acronym
- LIDO-TAPP
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared because the study involves sensitive clinical data and no public data-sharing plan has been established.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Lidocaine on Postoperative Fatigue Syndrome in Patients Undergoing Elective Laparoscopic TAPP Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT07612839
- Acronym / sponsor ID
- LIDO-TAPP / 25-42
- Keywords
- Intravenous Lidocaine, Postoperative Fatigue, Laparoscopic TAPP Repair, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hakan EmirkadıUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 May 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.
This prospective randomized placebo-controlled trial aims to evaluate the effect of perioperative intravenous lidocaine on postoperative fatigue in patients undergoing elective laparoscopic TAPP inguinal hernia repair. Participants will be randomly assigned to receive either intravenous lidocaine or an equal-volume 0.9% sodium chloride placebo. The primary outcome is postoperative physical fatigue assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20). Secondary outcomes include postoperative pain, cumulative tramadol consumption, postoperative nausea and vomiting, and the requirement for additional analgesia.
Detailed description
Postoperative fatigue may negatively affect recovery after surgery. Intravenous lidocaine has analgesic, anti-inflammatory, and opioid-sparing properties that may influence postoperative recovery.
This prospective randomized placebo-controlled trial will include adult patients undergoing elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair under general anesthesia. Eligible participants will be randomly allocated to receive either perioperative intravenous lidocaine or an equal-volume 0.9% sodium chloride placebo according to the same administration schedule. Participants, anesthesia care providers, and postoperative outcome assessors will be blinded to treatment allocation.
The primary outcome is postoperative physical fatigue assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20), with a preoperative baseline assessment and postoperative assessments on days 1, 3, 5, and 7. Secondary outcomes include postoperative pain intensity, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and the requirement for additional analgesia during the first 24 postoperative hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intravenous lidocaine group or the control group in a parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: LidocaineParticipants in this group will receive intravenous lidocaine based on ideal body weight. A loading dose of 1.5 mg/kg will be administered intravenously over 10 minutes before surgery, followed by a continuous infusion of 1.5 mg/kg/hour until the end of surgery. The infusion will be discontinued if signs suggestive of local anesthetic systemic toxicity or clinically significant unexplained hemodynamic or cardiac conduction abnormalities occur. |
| Control Group | Placebo comparator | Drug: 0.9 % sodium chlorideParticipants in this group will receive an equal-volume 0.9% sodium chloride placebo administered according to the same timing and infusion protocol as the lidocaine group. Standard perioperative care will otherwise be identical between groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years
- Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair
- American Society of Anesthesiologists (ASA) physical status I or II
- Able to understand and complete the Multidimensional Fatigue Inventory-20 (MFI-20)
- Written informed consent provided
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to lidocaine or other amide-type local anesthetics
- Clinically significant hepatic or renal dysfunction
- Clinically significant cardiac rhythm or conduction disorder
- Chronic opioid use
- Regular use of antiarrhythmic medication
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 |
|---|---|---|
| LidocainePerioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair. | Drug | Lidocaine Group |
| 0.9 % sodium chloride0.9% sodium chloride will be administered intravenously as placebo in an equal volume and according to the same timing and infusion protocol as the lidocaine intervention. | Drug | Control Group |
Primary outcome
MFI-20 Physical Fatigue Subscale Score
Time frame: Preoperative baseline and postoperative days 1, 3, 5, and 7
Postoperative physical fatigue will be assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20). The Physical Fatigue subscale consists of four items and ranges from 4 to 20 points, with higher scores indicating greater physical fatigue. A preoperative assessment will be obtained as the baseline value. Postoperative assessments will be performed on postoperative days 1, 3, 5, and 7.
4 secondary outcomes
Postoperative Pain Intensity (11-point Numeric Rating Scale)
Time frame: 2, 4, 6, 12, and 24 hours after surgery and postoperative days 3, 5, and 7
Postoperative Nausea and Vomiting Within 24 Hours
Time frame: First 24 hours after surgery
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
Time frame: First 24 hours after surgery
Requirement for Additional Analgesia During the First 24 Postoperative Hours
Time frame: First 24 hours after 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 4 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared because the study involves sensitive clinical data and no public data-sharing plan has been established.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and 0.9 % sodium chloride in people with Postoperative Fatigue Syndrome and Inguinal Hernia Unilateral, run by Hakan Emirkadı at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hakan Emirkadı, MD (+905322609367, hemirkadi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MFI-20 Physical Fatigue Subscale Score (time frame: Preoperative baseline and postoperative days 1, 3, 5, and 7). 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 4 Sep 2026.