Appendectomy, LaparoscopicL-TAPNCT07921862
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
A study testing Bupivacaine (Transversus Abdominis Plane Block) in people with Appendectomy, Laparoscopic and Blockades Neuromuscular, run by Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Appendectomy is one of the most frequently performed surgical procedures worldwide and remains the gold standard treatment for acute appendicitis. Although laparoscopic surgery offers advantages such as less pain, faster recovery, and shorter hospital stays compared to open techniques, postoperative pain caused by… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Appendectomy, Laparoscopic, Blockades Neuromuscular, Analgeisa
- What is being tested?
- Bupivacaine (Transversus Abdominis Plane Block)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 30 Oct 2028
- 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
- Patients aged between 18 and 65 years
- Patients undergoing uncomplicated laparoscopic appendectomy
- Patients with American Society of Anesthesiologists physical status I-III
Who cannot join
- Presence of appendiceal perforation or complicated appendicitis (such as abscess or peritonitis)
- Anatomical abnormalities or deformities of the anterior abdominal wall
- Known hypersensitivity or allergy to local anesthetics (such as bupivacaine or amide-type local anesthetics)
- Morbid obesity, defined as a Body Mass Index greater than 40 kg/m²
- History of opioid, alcohol, or substance abuse or dependence
- Active or severe psychiatric illness that may interfere with the study protocol
Show all 14Show fewer
- Inability to communicate in the local language or requiring an interpreter
- Known coagulation disorders, bleeding diathesis, or active anticoagulant therapy
- Total body weight less than 50 kg
- History of cardiac arrhythmia or severe cardiac conduction defects
- Pre-existing neurological deficits or peripheral neuropathy at the procedure or injection site
- Cognitive impairment, inability to understand the study procedures, or inability to appropriately respond to questionnaires
- Pregnancy or lactation
- History of major abdominal surgery that may alter the abdominal wall anatomy or laparoscopic visibility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan İl Sağlik Müdürlüğü Binali Yildirim Üniversitesi Mengücek Gazi Eğitim Ve Araştirma Hastanesi
Erzincan, Merkez, 24100
About this study
Official title: Efficacy of Laparoscopic-Assisted Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Appendectomy: A Randomized Controlled Trial
Appendectomy is one of the most frequently performed surgical procedures worldwide and remains the gold standard treatment for acute appendicitis. Although laparoscopic surgery offers advantages such as less pain, faster recovery, and shorter hospital stays compared to open techniques, postoperative pain caused by visceral stimulation from pneumoperitoneum and tissue trauma is still inevitable. Inadequate analgesia delays the recovery process, whereas high-dose opioid use leads to complications such as nausea, vomiting, and respiratory depression. Therefore, within the framework of Enhanced Recovery After Surgery (ERAS) protocols, multimodal analgesia methods and interfacial plane blocks that reduce opioid consumption have gained prominence. The Transversus Abdominis Plane (TAP) block is an effective regional anesthesia technique where a local anesthetic is injected into the fascial plane between the internal oblique and transversus abdominis muscles. Initially described using anatomical landmarks, this method has become widely used with the addition of ultrasound guidance. The TAP block features different modalities, including subcostal, lateral, posterior, dual, and surgeon-performed laparoscopic-assisted approaches. While the subcostal approach targets the supraumbilical (T7-9) region, the lateral and posterior approaches block the infraumbilical (T10-L1) nerve branches. In recent years, the transperitoneal approach, performed by the surgeon under direct vision during laparoscopic surgery, has gained popularity. This technique is performed by advancing the needle through the parietal peritoneum into the transversus abdominis muscle. Due to direct visualization, the risk of visceral injury decreases, and the success rate of delivering the drug to the correct fascial plane increases. This study aims to evaluate and compare the efficacy of surgeon-performed laparoscopic-assisted transversus abdominis plane block versus standard intravenous analgesia in patients undergoing laparoscopic appendectomy.
Read the detailed description
Laparoscopic appendectomy is the most frequently performed surgical procedure for patients presenting with acute appendicitis. Compared to open appendectomy, this technique offers significant advantages, including a lower risk of complications, reduced postoperative pain, and a faster return to daily activities. Although the laparoscopic technique is minimally invasive, postoperative pain remains inevitable. This discomfort can restrict patient mobility and prolong the duration of hospital stay. The Transversus Abdominis Plane (TAP) block is a regional anesthesia procedure involving the injection of a local anesthetic solution into the TAP zone of the abdominal wall. Recently, this procedure has gained widespread popularity for its efficacy in reducing both postoperative pain and opioid analgesic requirements after various abdominal surgeries. The TAP block has been widely utilized in numerous operations, including colorectal surgery, upper gastrointestinal surgeries, cholecystectomy, appendectomy, hysterectomy, and prostatectomy. Various approaches exist for its clinical application. It has been reported that ultrasound-guided TAP block significantly reduces pain in patients following laparoscopic appendectomy. Similarly, literature demonstrates that this method shortens the length of stay in the post-anesthesia care unit (PACU) and decreases intraoperative analgesic requirements in patients undergoing laparoscopic appendectomy. Regarding the laparoscopically-assisted approach, studies state that laparoscopic TAP (LTAP) block provides a significant reduction in pain scores up to 24 hours postoperatively, as well as lower rates of postoperative nausea and vomiting (PONV). The analgesic efficacy of LTAP was also emphasized by findings showing that this method ensures effective pain control at abdominal incision sites, reduces narcotic consumption, and shortens the hospital stay after laparoscopic colorectal surgery. On the other hand, it is noted that there is still no clear consensus in the literature regarding whether the TAP block is the most effective option for pain management after laparoscopic appendectomy. Due to the lack of definitive and conclusive results in the literature regarding the LTAP block in laparoscopic appendectomy patients, this study aims to evaluate and compare the postoperative analgesic requirements, efficacy, and safety of the LTAP block versus standard intravenous analgesia.
- Conditions
- Appendectomy, Laparoscopic, Blockades Neuromuscular, Analgeisa, Local Analgesia Via Nerve Block
- Being tested
- Bupivacaine (Transversus Abdominis Plane Block)
- Keywords
- TRANSVERSUS ABDOMINIS PLANE BLOCK, LAPAROSCOPIC-ASSISTED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine (Transversus Abdominis Plane Block)Drug
Also called LTAP
At the end of the operation, a bilateral laparoscopic-assisted transversus abdominis plane (LTAP) block will be performed by the attending surgeon under direct laparoscopic visualization. Under sterile conditions, the facial plane between the internal oblique and transversus abdominis muscles will be accessed at the level of the mid-axillary line using a Braun Stimuplex A insulated needle. The correct placement will be confirmed by feeling the facial transition (two distinct "pop" sensations) and visualizing the inward pushing of the peritoneum (Doyle's internal bulge sign). Following negative aspiration to prevent intravascular injection, a total of 20 mL of 0.25% bupivacaine (Marcaine) will be administered as a 10 mL injection to each side (bilateral) into the fascial plane.
| Study group | Role | What they receive |
|---|---|---|
| LTAP | Experimental | At the end of the operation, a bilateral laparoscopic-assisted transversus abdominis plane (LTAP) block will be performed by the attending surgeon under direct laparoscopic visualization. Receives: Drug: Bupivacaine (Transversus Abdominis Plane Block) |
| STANDARD ANALGESIA GROUP | No intervention | STANDARD ANALGESIA GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores Assessed by the Visual Analog Scale
Postoperative pain severity will be evaluated using the Visual Analog Scale. The scale ranges from a minimum value of 0, representing no pain, to a maximum value of 10, representing the worst possible pain. Higher scores mean a worse outcome, indicating more severe pain.
Measured: Postoperative 2nd, 4th, 8th, 12th, and 24th hours
Total Postoperative Analgesic Consumption in Milligrams
The total cumulative dose of intravenous analgesic agents (such as tramadol, paracetamol, or opioids) administered to the patient as rescue analgesia within the first 24 hours after surgery. The total amount will be calculated and recorded in milligrams (mg). Higher cumulative values mean a worse outcome, indicating a greater requirement for pain medication.
Measured: First 24 hours postoperatively
Secondary outcomes (4)
Total Tramadol Consumption
The total cumulative administration of intravenous or oral tramadol provided to the patient as analgesia within the specified postoperative timeframe. The consumption data is documented to assess pain management requirements following the surgical procedure.
Measured: First 24 hours postoperatively
Incidence of Postoperative Nausea and Vomiting
The occurrence of postoperative nausea and vomiting (PONV) episodes will be monitored and documented during the first 24 hours after the surgical procedure. This outcome will be recorded as a percentage of patients experiencing symptoms within each study group. Higher percentages mean a worse outcome, indicating a higher rate of postoperative complications.
Measured: Up to 24 hours postoperatively
Time to First Flatus or Defecation in Hours
The time elapsed from the end of the surgery until the first postoperative passage of flatus or defecation, measured in hours. This parameter is used to objectively evaluate gastrointestinal motility recovery. A shorter time frame indicates a better outcome, representing earlier return of bowel function.
Measured: Up to hospital discharge (approximately 48 hours)
Postoperative Sleep Quality
Assessment of the patient's subjective sleep quality during the first postoperative night (e.g., using a numerical rating scale or questionnaire).
Measured: Postoperative 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Aug 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendectomy, LaparoscopicStudies 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
- This study will be conducted among volunteers who present to the General Surgery Clinic at Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital, are diagnosed with acute appendicitis, and are scheduled to undergo laparoscopic appendectomy.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Erzincan Binali Yildirim Universitesi
- Responsible party
- Principal investigator, Kenan Gözal, Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
- Investigators
- kenan gözal, doctor, Principal investigator, ERZİNCAN İL SAĞLIK MÜDÜRLÜĞÜ BİNALİ YILDIRIM ÜNİVERSİTESİ MENGÜCEK GAZİ EĞİTİM VE ARAŞTIRMA HASTANESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921862
- Sponsor's protocol ID
- MengucekGaziTRH
- Other IDs
- MengucekGaziTRH
- Acronym
- L-TAP
- Status last verified
- Nov 2026
- First submitted
- 26 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laparoscopic-Assisted Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Appendectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07921862
- Acronym / sponsor ID
- L-TAP / MengucekGaziTRH
- Conditions
- Appendectomy, Laparoscopic, Blockades Neuromuscular, Analgeisa, Local Analgesia Via Nerve Block
- Keywords
- TRANSVERSUS ABDOMINIS PLANE BLOCK, LAPAROSCOPIC-ASSISTED
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Erzincan Binali Yildirim University Mengucek Gazi Training and Research HospitalOther government
- Collaborators
- Erzincan Binali Yildirim Universitesi
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 6 Nov 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.
Appendectomy is one of the most frequently performed surgical procedures worldwide and remains the gold standard treatment for acute appendicitis. Although laparoscopic surgery offers advantages such as less pain, faster recovery, and shorter hospital stays compared to open techniques, postoperative pain caused by visceral stimulation from pneumoperitoneum and tissue trauma is still inevitable. Inadequate analgesia delays the recovery process, whereas high-dose opioid use leads to complications such as nausea, vomiting, and respiratory depression. Therefore, within the framework of Enhanced Recovery After Surgery (ERAS) protocols, multimodal analgesia methods and interfacial plane blocks that reduce opioid consumption have gained prominence. The Transversus Abdominis Plane (TAP) block is an effective regional anesthesia technique where a local anesthetic is injected into the fascial plane between the internal oblique and transversus abdominis muscles. Initially described using anatomical landmarks, this method has become widely used with the addition of ultrasound guidance. The TAP block features different modalities, including subcostal, lateral, posterior, dual, and surgeon-performed laparoscopic-assisted approaches. While the subcostal approach targets the supraumbilical (T7-9) region, the lateral and posterior approaches block the infraumbilical (T10-L1) nerve branches. In recent years, the transperitoneal approach, performed by the surgeon under direct vision during laparoscopic surgery, has gained popularity. This technique is performed by advancing the needle through the parietal peritoneum into the transversus abdominis muscle. Due to direct visualization, the risk of visceral injury decreases, and the success rate of delivering the drug to the correct fascial plane increases. This study aims to evaluate and compare the efficacy of surgeon-performed laparoscopic-assisted transversus abdominis plane block versus standard intravenous analgesia in patients undergoing laparoscopic appendectomy.
Detailed description
Laparoscopic appendectomy is the most frequently performed surgical procedure for patients presenting with acute appendicitis. Compared to open appendectomy, this technique offers significant advantages, including a lower risk of complications, reduced postoperative pain, and a faster return to daily activities. Although the laparoscopic technique is minimally invasive, postoperative pain remains inevitable. This discomfort can restrict patient mobility and prolong the duration of hospital stay. The Transversus Abdominis Plane (TAP) block is a regional anesthesia procedure involving the injection of a local anesthetic solution into the TAP zone of the abdominal wall. Recently, this procedure has gained widespread popularity for its efficacy in reducing both postoperative pain and opioid analgesic requirements after various abdominal surgeries. The TAP block has been widely utilized in numerous operations, including colorectal surgery, upper gastrointestinal surgeries, cholecystectomy, appendectomy, hysterectomy, and prostatectomy. Various approaches exist for its clinical application. It has been reported that ultrasound-guided TAP block significantly reduces pain in patients following laparoscopic appendectomy. Similarly, literature demonstrates that this method shortens the length of stay in the post-anesthesia care unit (PACU) and decreases intraoperative analgesic requirements in patients undergoing laparoscopic appendectomy. Regarding the laparoscopically-assisted approach, studies state that laparoscopic TAP (LTAP) block provides a significant reduction in pain scores up to 24 hours postoperatively, as well as lower rates of postoperative nausea and vomiting (PONV). The analgesic efficacy of LTAP was also emphasized by findings showing that this method ensures effective pain control at abdominal incision sites, reduces narcotic consumption, and shortens the hospital stay after laparoscopic colorectal surgery. On the other hand, it is noted that there is still no clear consensus in the literature regarding whether the TAP block is the most effective option for pain management after laparoscopic appendectomy. Due to the lack of definitive and conclusive results in the literature regarding the LTAP block in laparoscopic appendectomy patients, this study aims to evaluate and compare the postoperative analgesic requirements, efficacy, and safety of the LTAP block versus standard intravenous analgesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study will be conducted among volunteers who present to the General Surgery Clinic at Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital, are diagnosed with acute appendicitis, and are scheduled to undergo laparoscopic appendectomy.
| Arm | Type | Receives |
|---|---|---|
| LTAP | Experimental | Drug: Bupivacaine (Transversus Abdominis Plane Block)At the end of the operation, a bilateral laparoscopic-assisted transversus abdominis plane (LTAP) block will be performed by the attending surgeon under direct laparoscopic visualization. |
| STANDARD ANALGESIA GROUP | No intervention | –STANDARD ANALGESIA GROUP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years
- Patients undergoing uncomplicated laparoscopic appendectomy
- Patients with American Society of Anesthesiologists physical status I-III
Key exclusion criteria (14 listed)
- Presence of appendiceal perforation or complicated appendicitis (such as abscess or peritonitis)
- Anatomical abnormalities or deformities of the anterior abdominal wall
- Known hypersensitivity or allergy to local anesthetics (such as bupivacaine or amide-type local anesthetics)
- Morbid obesity, defined as a Body Mass Index greater than 40 kg/m²
- History of opioid, alcohol, or substance abuse or dependence
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 |
|---|---|---|
| Bupivacaine (Transversus Abdominis Plane Block)Also: LTAPAt the end of the operation, a bilateral laparoscopic-assisted transversus abdominis plane (LTAP) block will be performed by the attending surgeon under direct laparoscopic visualization. Under sterile conditions, the facial plane between the internal oblique and transversus abdominis muscles will be accessed at the level of the mid-axillary line using a Braun Stimuplex A insulated needle. The correct placement will be confirmed by feeling the facial transition (two distinct "pop" sensations) and visualizing the inward pushing of the peritoneum (Doyle's internal bulge sign). Following negative aspiration to prevent intravascular injection, a total of 20 mL of 0.25% bupivacaine (Marcaine) will be administered as a 10 mL injection to each side (bilateral) into the fascial plane. | Drug | LTAP |
Primary outcome
Postoperative Pain Scores Assessed by the Visual Analog Scale
Time frame: Postoperative 2nd, 4th, 8th, 12th, and 24th hours
Postoperative pain severity will be evaluated using the Visual Analog Scale. The scale ranges from a minimum value of 0, representing no pain, to a maximum value of 10, representing the worst possible pain. Higher scores mean a worse outcome, indicating more severe pain.
Total Postoperative Analgesic Consumption in Milligrams
Time frame: First 24 hours postoperatively
The total cumulative dose of intravenous analgesic agents (such as tramadol, paracetamol, or opioids) administered to the patient as rescue analgesia within the first 24 hours after surgery. The total amount will be calculated and recorded in milligrams (mg). Higher cumulative values mean a worse outcome, indicating a greater requirement for pain medication.
4 secondary outcomes
Total Tramadol Consumption
Time frame: First 24 hours postoperatively
Incidence of Postoperative Nausea and Vomiting
Time frame: Up to 24 hours postoperatively
Time to First Flatus or Defecation in Hours
Time frame: Up to hospital discharge (approximately 48 hours)
Postoperative Sleep Quality
Time frame: Postoperative 24 hours.
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 6 Nov 2026.
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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. This study is not recruiting at the moment.
kenan gözal, doctor principal investigator
ERZİNCAN İL SAĞLIK MÜDÜRLÜĞÜ BİNALİ YILDIRIM ÜNİVERSİTESİ MENGÜCEK GAZİ EĞİTİM VE ARAŞTIRMA HASTANESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine (Transversus Abdominis Plane Block) in people with Appendectomy, Laparoscopic and Blockades Neuromuscular, run by Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital 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 3 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores Assessed by the Visual Analog Scale (time frame: Postoperative 2nd, 4th, 8th, 12th, and 24th hours). The study lists 2 primary outcomes in all. 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 6 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.