SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, Bakirkoy, 34147, Turkey (Türkiye)
NCT Number: NCT07264855
Laparoscopic gynecologic surgery is less invasive than open surgery, but many patients still experience pain after the procedure. M-TAPA and EXOP are ultrasound-guided regional anesthesia techniques used to reduce abdominal pain. Previous research suggests that M-TAPA provides effective pain relief on the anterior abdominal wall, while EXOP may help reduce pain in the lateral abdominal region. This study aims to determine whether combining M-TAPA with EXOP provides better postoperative pain control than using M-TAPA alone. The study will compare pain scores during the first 24 hours after surgery, the need for rescue analgesic medication, and recovery quality using the QoR-15 questionnaire. All procedures are part of routine clinical care, and no experimental drugs or devices are used.
This study is active but is not currently recruiting participants.
Notify Me18 year–90 year
Female
Observational
Istanbul, Bakirkoy, 34147, Turkey (Türkiye)
In routine practice at our institution, anesthesia clinicians performing gynecologic laparoscopic procedures administer either modified thoracoabdominal nerve block through perichondrial approach (M-TAPA Block) alone or a combination of M-TAPA and external oblique muscle plane (EXOP) blocks, based solely on individual clinician preference. The researcher does not influence this decision. Among the eligible patients, those receiving either M-TAPA or M-TAPA + EXOP will be included and evaluated observationally. Block types other than these two will not be included.
All postoperative visits and clinical follow-ups are routinely conducted by the hospital's pain management team. The researcher does not intervene in these clinical processes and is only responsible for obtaining informed consent, recording demographic variables, documenting the type of block performed, administering the QoR-15 questionnaire, and evaluating sensory block distribution using the pinprick test.
Preoperative evaluation and necessary laboratory testing are carried out according to standard hospital practice by the attending anesthesiologist. The researcher obtains informed consent, records demographic data, and administers the preoperative QoR-15 questionnaire.
In the operating room, standard monitoring (non-invasive blood pressure, ECG, heart rate, and oxygen saturation) is applied, intravenous access is established, and crystalloid infusion is initiated. Anesthesia induction is performed using propofol, an opioid, and a neuromuscular blocking agent, followed by endotracheal intubation. General anesthesia is maintained with sevoflurane in an oxygen-air mixture. Laparoscopic surgery is performed with gradual CO₂ insufflation, maintaining intra-abdominal pressure below 12 mmHg.
For postoperative analgesia, all patients routinely receive 1 g intravenous paracetamol and 100 mg tramadol. After surgery, neuromuscular blockade is reversed and patients are transferred to the post-anesthesia care unit (PACU).
After surgery, patients are monitored in the PACU and transferred to the ward once their Aldrete score is ≥9. All patients receive 1 g intravenous paracetamol every 8 hours as per routine protocol. Postoperative pain is assessed by the pain team using the 0-10 Numeric Rating Scale (NRS).
Postoperative nausea and vomiting (PONV) are assessed and intravenous ondansetron 4 mg is administered for PONV ≥2. Patients without PONV are encouraged to mobilize early and resume oral intake. Discharge is permitted once symptoms resolve; however, all patients remain hospitalized for at least 24 hours.
As an additional study-related procedure, the researcher evaluates dermatomal spread using the pinprick test and administers the QoR-15 questionnaire at 24 hours.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A bilateral modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is performed under ultrasound guidance in the supine position prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is positioned at the level of the 10th rib in the sagittal plane. The needle is advanced to the fascial plane between the internal oblique and transversus abdominis muscles. Following negative aspiration and confirmation of correct plane identification with hydrodissection, 20 mL of 0.25% bupivacaine is injected bilaterally (total volume 40 mL). The procedure is performed by anesthesiologists experienced in gynecologic surgery, without researcher involvement in clinical decision-making
Other names: M-TAPA Block
Following completion of the bilateral M-TAPA block, an external oblique muscle plane (EXOP) block is performed under ultrasound guidance as part of routine clinical practice. The ultrasound probe is positioned over the lateral abdominal wall between the costal margin and iliac crest. After negative aspiration and confirmation of correct plane identification with hydrodissection, 20 mL of 0.125% bupivacaine is injected on each side into the fascial plane superficial to the external oblique muscle (total volume 80 mL).
Other names: M-TAPA + EXOP Block
Time frame: 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 2, 6, 12, and 24 hours after surgery and will be compared between Group M and Group E.
The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
Time frame: First 24 hours after surgery
The total amount of rescue analgesic medication (intravenous tramadol, mg) administered in the first 24 hours will be recorded. Requirements will be compared between Group M and Group E.
Time frame: Preoperative baseline and postoperative 24th hour
The quality of recovery will be assessed using the validated QoR-15 questionnaire. Scores will be compared between Group M and Group E to evaluate the impact of each block technique on postoperative recovery.
QoR-15 total score ranges from 0 to 150; higher scores indicate better quality of recovery
Time frame: First 24 hours after surgery
The time interval (in minutes) from the end of surgery to the first request for rescue analgesia will be recorded. Rescue analgesia will consist of intravenous 100 mg tramadol administered when the patient reports an NRS pain score ≥ 4. Results will be compared between Group M and Group E.
Time frame: 1, 2, 6, 12, and 24 hours after surgery
Sensory block distribution will be assessed using the pinprick test to evaluate dermatomal spread. Results will be compared between Group M and Group E.
Time frame: First 24 hours after surgery
Postoperative nausea and vomiting will be assessed using a verbal descriptive scale from 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = single vomiting episode, 4 = multiple vomiting episodes). Scores will be compared between the two groups.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Other Gov
Comparison of the Effects of M-TAPA Versus the Combination of M-TAPA and EXOP Blocks on Postoperative Pain in Laparoscopic Gynecologic Surgeries
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01534416
Laparoscopic Gynecologic Surgery, Neurologic Manifestations
New York, United States
View Trial DetailsNCT07327957
Anxiety, Anxiety Disorders
Erzurum, Turkey (Türkiye)
View Trial DetailsNCT07699432
Apical Periodontitis, Jaw Diseases
Irbid, Northen, Jordan
View Trial DetailsNCT04754165
Bariatric Surgery Candidate, Neurologic Manifestations
Boston, Massachusetts, United States
View Trial Details