An interventional study of M-TAPA and EOB in Cholecystitis and Cholecystitis, Acute, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
Ultrasound (US)-guided Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia in the anterior and lateral abdominal walls after laparoscopic surgery, and local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall and may be an opioid-sparing strategy with good quality recovery in patients undergoing laparoscopic surgery.
US-guided External oblique intercostal block (EOB) is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia between T6-T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing M-TAPA and EOB yet.
In this study, our aim is to compare the effectiveness of US-guided M-TAPA block and EOB for postoperative analgesia management after laparoscopic cholecystectomy surgery. Our primary aim is to compare patient recovery scores (QoR15 Turkish version), our secondary aim is to compare postoperative pain scores (24-hour NRS), postoperative rescue analgesic use (opioid), and opioid-related side effects (allergic reaction, nausea, vomiting).
Cholecystectomy is the most common of the abdominal surgical procedures performed in developed countries and is usually performed laparoscopically. Many factors play a role in the pain that develops after laparoscopic cholecystectomy and is generally considered to be visceral pain. Phrenic nerve irritation as a result of CO2 insufflation into the peritoneal cavity, abdominal distention, tissue trauma, trauma due to the removal of the gallbladder, sociocultural status, and individual factors are the factors that play a role in the emergence of this pain.
Postoperative pain is acute pain that is accompanied by an inflammatory process due to surgical trauma and gradually decreases with tissue healing. Postoperative pain in patients undergoing laparoscopic cholecystectomy is a serious problem that reduces patient comfort and delays the patient's return to work after surgery. Successful postoperative analgesia, occurs in the patient due to pain; It is a known fact that it prevents many of the effects such as not being able to breathe easily and delayed mobilization.
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a new block that provides effective analgesia in the anterior and lateral abdominal walls after laparoscopic surgery in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall and may be an opioid-sparing strategy with good quality recovery in patients undergoing laparoscopic surgery.
M-TAPA block provides analgesia in the T5-T11 abdominal region. Sonoanatomy is easy to visualize on US and the spread of local anesthetic can be easily seen. With the cephalo-caudal spread of the local anesthetic solution, analgesia occurs in several dermatomes. In the literature, there are studies investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery. In the literature, there is no randomized study evaluating the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic cholecystectomy operation.
US-guided External oblique intercostal block (EOB) is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia between T6-T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing M-TAPA and EOB yet.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 60 is below the median of 86 across 167 interventional studies indexed under Cholecystitis.
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Exclusion Criteria:
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 0,5 mg/kg meperidin will be performed for rescue analgesia.
Drug: M-TAPA
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 0,5 mg/kg meperidin will be performed for rescue analgesia.
Drug: EOB
Under aseptic conditions, a high-frequency linear probe will be placed on the costochondral angle in the sagittal plane. Then the probe will be slightly angled deeply to visualize the lower view of the perichondrium. We will perform M-TAPA with total of 40 ml (20 ml for each side) of %0,25 bupivacaine.
In the supine position, a high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed on the midaxillary line between the spina iliaca anterior superior and the umbilicus. Using the In-Plane technique, 5 ml of saline will be injected under the external oblique muscle of the block needle and the block location will be confirmed. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be administered. The same procedure will be applied to the other side (40 ml of 0.25% bupivacaine in total).
Global recovery scoring system (patient satisfaction scale)
We will use the Turkish version of Quality of Recovery / QoR-15 questionairre
Time frame: Change from baseline score at postoperative 24 hour
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Change from Baseline Pain Scores at Postoperative 24 hours.
Time frame: Postoperative 24 hours period (0, 2, 4, 8, 16 ve 24 h)
The use of rescue analgesia
Meperidin using (Number of Participants and Concentration of Meperidin)
Time frame: Postoperative 24 hours period
Plan to share: No — Individual participant data (IPD) will not be shared
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Medipol University