General hospital of Ningxia medical university
Yinchuan, Ningxia, China
Location status: Recruiting
NCT Number: NCT07396545
Postoperative pain is highly prevalent following laparoscopic radical gastrectomy. Although the erector spinae plane block (ESPB) can effectively alleviate this pain, it still has many limitations. The external oblique intercostal plane block (EOIB) is a novel nerve block technique that may provide well postoperative analgesia for upper abdominal surgery. Therefore, this study employs a non-inferiority randomized controlled trial design to verify that the analgesic effect of EOIB is not inferior to that of ESPB, thereby offering more options for regional analgesia strategies in laparoscopic radical gastrectomy.
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All sexes
Interventional
Not applicable
Yinchuan, Ningxia, China
Location status: Recruiting
Laparoscopic radical gastrectomy (including subtotal and total gastrectomy) is the most commonly used surgical approach for gastric cancer. Although this technique is less invasive than traditional open surgery, more than 50% of patients still experience moderate to severe acute pain in the early postoperative period, making effective postoperative pain management essential. Regional nerve blockade techniques have become a key component of postoperative analgesia due to their reliable analgesic effect and significant reduction in opioid consumption.
The erector spinae plane block (ESPB) is considered a relatively safe nerve block for upper abdominal surgery analgesia. However, the spread of the local anesthetic and the resulting block effect are unpredictable. Moreover, ESPB cannot be performed with the patient in the supine position and may present technical challenges in obese patients.
The external oblique intercostal plane block (EOIB) is a recently proposed regional block technique for the upper abdomen. This block involves injecting local anesthetic into the superficial fascial plane between the external oblique muscle and the intercostal muscles, thereby blocking the anterior rami and cutaneous branches of the intercostal nerves from T6-T10, which can provide effective analgesia for upper abdominal incision areas.
Nevertheless, current research on the analgesic effect of EOIB after laparoscopic radical gastrectomy remains limited, particularly lacking high-quality, prospective, randomized controlled studies to verify whether EOIB can achieve analgesic effects comparable to those of ESPB. Therefore, this study adopts a non-inferiority randomized controlled trial design to verify that the postoperative analgesic effect of EOIB is not inferior to that of ESPB, providing more options for regional analgesia strategies in laparoscopic radical gastrectomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
With the patient in the supine position, a high-frequency linear array probe (6-15 MHz) is used to perform a sagittal parasagittal oblique scan at the level of the 6th rib, between the right anterior axillary line and midclavicular line. The external oblique muscle, intercostal muscles, and ribs are identified. Using an in-plane technique, a 21G, 100mm block needle is inserted from a superomedial to inferolateral direction, with the needle tip positioned in the plane between the external oblique muscle and the intercostal muscles at the caudal edge of the 6th rib. 30ml of 0.375% ropivacaine is injected on each side, for a bilateral administration.
With the patient in the lateral decubitus position (surgical side up), a low-frequency convex array probe (2-5 MHz) is used to perform a sagittal scan approximately 2-3 cm lateral to the spinous process of T8 or T9. The transverse process and the erector spinae muscle are identified. Using an out-of-plane technique, a 21G, 100mm block needle is advanced until contact is made with the transverse process. The needle is then withdrawn 1-2 mm to position its tip within the fascial plane deep to the erector spinae muscle and superficial to the transverse process. 30 ml of 0.375% ropivacaine is injected on each side, for a bilateral administration.
Time frame: 24 hours after surgery
Cumulative opioid consumption within 24 hours postoperatively. Conversion to morphine equivalent dose (mg)
Time frame: 2, 6, 12, 24, 48, and 72 hours postoperatively
Pain at rest and during coughing will be assessed using the Numerical Rating Scale (NRS, 0-10) at 2, 6, 12, 24, 48, and 72 hours postoperatively.0 represents no pain, and 10 represents the most pain.
Time frame: 24,48,72 hours after surgery
The 15-item Quality of Recovery scale (QoR-15) was used for assessment at 24, 48, and 72 hours postoperatively. The higher the score, the better the recovery quality
Time frame: 24,48,72 hours after surgery
Sleep quality was assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on postoperative nights.0 points represent very poor sleep, while 100 points represent very good sleep
Contact information is provided by the study sponsor or research team.
General Hospital of Ningxia Medical University
Other
Effects of Ultrasound-guided External Oblique Intercostal Block Versus Erector Spinae Plane Block on Postoperative Pain in Laparoscopic Radical Gastrectomy
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