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| Name | Class |
|---|---|
| Cairo University | OTHER |
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This randomized controlled trial aims to compare the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block (ESPB) versus bilateral external oblique intercostal plane (EOI) block in patients undergoing open cholecystectomy.
Patients will be randomly allocated into two groups to receive either ESPB or EOI block in addition to standard general anesthesia. The primary outcome is postoperative pain score assessed using the Numerical Rating Scale (NRS) at 2 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative nalbuphine requirements, time to first analgesic request, and hemodynamic changes.
This study seeks to determine the more effective regional anesthesia technique for improving perioperative analgesia in open cholecystectomy.
Open cholecystectomy is still indicated in selected patients such as those with complicated gallbladder disease or contraindications to laparoscopy. Effective perioperative pain management is essential to improve patient outcomes and reduce opioid consumption.
Regional anesthesia techniques have gained increasing interest, particularly with the use of ultrasound guidance. The erector spinae plane block (ESPB) is a relatively simple and widely used interfascial block that provides effective analgesia for abdominal surgeries. The external oblique intercostal plane (EOI) block is a newer technique targeting the upper abdominal wall.
In this prospective, randomized, double-blinded clinical trial, adult patients undergoing elective open cholecystectomy will be randomized into two groups. One group will receive bilateral ultrasound-guided ESPB, while the other group will receive bilateral ultrasound-guided EOI block, both performed after induction of general anesthesia and before surgical incision.
All patients will receive standardized general anesthesia. Pain will be assessed using the Numerical Rating Scale (NRS) at multiple time points postoperatively. Rescue analgesia with intravenous nalbuphine will be administered as needed.
The primary outcome is postoperative pain score at 2 hours. Secondary outcomes include intraoperative fentanyl consumption, total nalbuphine consumption over 24 hours, time to first analgesic request, hemodynamic parameters, and any block-related complications.
This study aims to provide evidence regarding the comparative effectiveness of ESPB and EOI block in open cholecystectomy surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector Spinae Plane Block Group | Experimental | Participants in this group will receive bilateral erector spinae plane block using local anesthetic for postoperative analgesia following open cholecystectomy. |
|
| External Oblique Intercostal Plane Block Group | Experimental | Participants in this group will receive bilateral external oblique intercostal plane block using local anesthetic for postoperative analgesia following open cholecystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block | Procedure | Bilateral erector spinae plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score (VAS) | Postoperative pain will be assessed using the Visual Analog Scale (VAS) at rest and during movement. | Within the first 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Total opioid consumption in the first 24 hours after surgery measured in morphine equivalents. | First 24 hours postoperatively |
| Time to First Analgesic Request | Time elapsed from the end of surgery to the first request for analgesia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khaled M Hassan mohamed, MD | Contact | 01153564555 | dr.khalid.azab@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Mansour, MD | Professor of Anesthesia, ICU and Pain Management, Faculty of Medicine, Cairo University | Principal Investigator |
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Individual participant data (IPD) will not be shared. The study investigators do not plan to make individual-level data publicly available. Results will be reported in aggregate form to ensure participant confidentiality.
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Participants will be randomly assigned to one of two parallel groups to receive either bilateral erector spinae plane block or bilateral external oblique intercostal plane block.
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The study is double-blinded. The anesthesiologist performing the block is not involved in intraoperative management or postoperative assessment. Patients, intraoperative care providers, and outcome assessors are blinded to group allocation.
| External Oblique Intercostal Plane Block | Procedure | Bilateral external oblique intercostal plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia. |
|
| Within 24 hours postoperatively |
| Postoperative Complications | Incidence of postoperative complications including nausea, vomiting, and respiratory complications. | Within 24 hours postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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