An interventional study of Bupivacaine (Transversus Abdominis Plane Block) in Appendectomy, Laparoscopic, Blockades Neuromuscular and Analgeisa, sponsored by Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bupivacaine (Transversus Abdominis Plane Block)
STANDARD ANALGESIA GROUP
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.
Also known as: LTAP
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.
Time frame: 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.
Time frame: First 24 hours postoperatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Postoperative 24 hours.
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Studies of the drug tested here: Bupivacaine
Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital