An interventional study of ESPB Block and EOPB Block in Postoperative Pain, Cholelithiasis and Acute Pain, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Treatment
This randomized controlled clinical trial investigates the comparative efficacy of two novel regional anesthesia techniques - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
A total of 90 patients aged 18-65 years, with ASA physical status I or II, were randomly assigned to one of three groups: ESPB, EOPB, or control. Blocks were performed under ultrasound guidance prior to surgical incision. Pain intensity was evaluated using the Visual Analog Scale (VAS), and rescue analgesic consumption was recorded over the first 24 hours postoperatively.
The study aims to determine whether ESPB or EOPB offers superior pain control and reduced opioid consumption, and to assess patient satisfaction and safety. The results will inform multimodal analgesia strategies for upper abdominal laparoscopic surgery.
Laparoscopic cholecystectomy (LC) is one of the most commonly performed upper abdominal surgeries. Despite being minimally invasive, LC is frequently associated with significant postoperative pain originating from both visceral and somatic sources. Inadequate pain control may lead to delayed recovery, increased opioid consumption, and patient dissatisfaction.
Regional anesthesia techniques have become increasingly important components of multimodal analgesia protocols for abdominal surgeries. Two recently described fascial plane blocks - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - have shown promising results in reducing postoperative pain in thoracic and abdominal procedures.
This prospective, randomized, controlled clinical trial was conducted to evaluate and compare the analgesic effectiveness of ESPB and EOPB in patients undergoing elective LC under general anesthesia. After obtaining ethical approval (Protocol No: 2024/17/840-938) and informed consent, 90 adult patients aged 18-65 years with ASA physical status I or II were enrolled.
Participants were randomized into three groups using a sealed envelope technique:
Group 1 (ESPB): Received bilateral ultrasound-guided ESPB at the T7-8 level using 20 mL of local anesthetic solution (10 mL 0.5% bupivacaine + 10 mL 2% lidocaine) preoperatively.
Group 2 (EOPB): Received ultrasound-guided EOPB using the same volume and mixture of local anesthetic.
Group 3 (Control): Did not receive any regional block.
Postoperative pain was assessed using the Visual Analog Scale (VAS) at regular intervals (15 minutes, and at 2, 4, 8, 12, 16, and 24 hours). Rescue analgesia consisted of 50 mg dexketoprofen trometamol administered when VAS ≥4. If pain persisted, 50 mg tramadol was given as a second-line analgesic.
Primary endpoints included postoperative VAS scores and total rescue analgesic consumption over 24 hours. Secondary endpoints included time to first analgesic requirement, side effects, complications related to blocks, and patient satisfaction.
Initial results indicated that both ESPB and EOPB significantly reduced postoperative pain and analgesic requirements compared to the control group. While EOPB was technically easier to perform, ESPB provided longer-lasting analgesia. These findings may support the integration of ESPB or EOPB into routine multimodal analgesia protocols for laparoscopic abdominal surgeries.
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 90 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Participants in this group received a bilateral ultrasound-guided erector spinae plane block (ESPB) at the T7-T8 vertebral level under general anesthesia prior to surgical incision. Under sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy.
Procedure: ESPB Block
Participants in this group received an external oblique intercostal plane block (EOPB) under ultrasound guidance prior to surgical incision. Under ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy.
Procedure: EOPB Block
Participants in this group did not receive any regional block. Postoperative analgesia was provided via standard systemic medications as needed. No regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted.
Drug: Standard Systemic Analgesia
Under sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy.
Under ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy.
No regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted.
Postoperative Pain Intensity (VAS Score)
Postoperative pain will be measured using the Visual Analog Scale (VAS), where patients rate their pain on a 0-10 scale (0 = no pain, 10 = worst imaginable pain).
Time frame: 0-24 hours postoperatively (measured at 15 min, 2, 4, 8, 12, 16, and 24 hours)
Total Rescue Analgesic Consumption (Dexketoprofen + Tramadol)
Total cumulative dose of rescue analgesics administered within the first 24 hours postoperatively will be recorded. Dexketoprofen (mg) and tramadol (mg) will be summed for each participant.
Time frame: 0-24 hours postoperatively
Time to First Rescue Analgesic Requirement
The time elapsed from the end of surgery to the administration of the first dose of rescue analgesic (dexketoprofen) will be recorded for each participant.
Time frame: 0-24 hours postoperatively
Patient Satisfaction Score
Patient satisfaction with pain management will be assessed at 24 hours using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Time frame: At 24 hours postoperatively
Incidence of Block-Related Complications
Incidence of complications related to regional blocks (e.g., local anesthetic toxicity, hematoma, nerve injury, pneumothorax) will be monitored and recorded.
Time frame: Intraoperative and within 24 hours postoperative
Intraoperative Opioid Requirement
Total intraoperative fentanyl dose (in mcg) administered during the procedure will be recorded.
Time frame: Intraoperative period (during surgery)
Plan to share: No — Individual participant data (IPD) will not be shared. The study was conducted as part of a postgraduate academic thesis, and ethical approval limits data use to the original analysis only. No public data repository or external sharing is planned.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Dr. Lutfi Kirdar Kartal Training and Research Hospital