Postoperative Pain
Conditions
Brief summary
Postoperative pain is highly prevalent following laparoscopic radical gastrectomy. Although Transversus abdominis plane block combined with rectus sheath block(TAP+RSB） 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.
Detailed description
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 transversus abdominis plane block combined with rectus sheath block(TAP+RSB) 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. 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 TAP+RSB， Therefore, this study adopts a non-inferiority randomized controlled trial design to verify that the postoperative analgesic effect of EOIB is better than TAP+RSB, providing more options for regional analgesia strategies in laparoscopic radical gastrectomy.
Interventions
PROCEDUREEOIB
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 administra
PROCEDURETAP+RSB
With the patient in the supine position, above the umbilicus, a linear ultrasound transducer was positioned transversely on the rectus abdominis muscle, and 15 mL of ropivacaine 0.375% was injected into both sides of the aspect between the rectus abdominis muscle and the posterior rectus sheath with a 22G 70-mm block needle using the in-plane technique. At the midaxillary line, a linear ultrasound transducer was positioned close and parallel to the lower costal margin. In the bilateral aspect between the internal oblique and transversus abdominis muscles, 15 mL of ropivacaine 0.375% was injected on each side with a 22G 70-mm block needle.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
On the day of surgery, after the induction of general anesthesia, the study coordinator opened the corresponding envelope in the order of recruitment. Patients were randomly assigned to receive either EOIB or TAP+RSB, which was performed preoperatively by an experienced anesthesiologist. The anesthesiologist was aware of the intervention, but all patients, data investigator and postoperative follow-up remained blinded to group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged over 18 years * Classified as ASA I-III * Scheduled for elective laparoscopic radical gastrectomy under general anesthesia * Voluntarily participated and provided written informed consent.
Exclusion criteria
* Chronic opioid dependence or prior use of analgesic medications for \>3 months; * Inability to communicate due to severe dementia, language barriers, or terminal illness; * History of central and/or peripheral nervous system disorders; * Severe renal insufficiency (serum creatinine \>442 μmol/L or requiring renal replacement therapy) or severe hepatic insufficiency (Child-Pugh class C); * Allergy to local anesthetics. * Expected to be transferred to ICU after surgery. * Refuse patient control agenesia after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid consumption within 24 hours postoperatively | 24 hours after surgery | Cumulative opioid consumption within 24 hours postoperatively. Conversion to morphine equivalent dose (mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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. |
| Quality of Recovery | 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 |
| sleep quality | 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 |
Countries
China
Contacts
CONTACTlingzi Yin, Doctoral
STUDY_DIRECTORlingzi Yin
General hospital of Ningxia medical university, Yinchuan, Ningxia
Outcome results
None listed