Laparoscopic Cholecystectomy Clinical Trial
Official title:
Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy, Is It a Promising Alternative Modality?
NCT number | NCT05158270 |
Other study ID # | 9090 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 15, 2021 |
Est. completion date | June 15, 2024 |
Adequate analgesic regimen is one of the most important key elements of Enhanced recovery after surgery (ERAS) protocols. The cornerstone of analgesia is multimodal analgesia combining local anesthetic (LA) techniques and trying to avoid parenteral opioids and their side effects. Subcostal approach to Anterior quadratus lumborum block (SAQLB), compared to other variants of quadratus lumborum blocks (QLBs), was associated with wider and longer sensory blockade, and provided somatic as well as visceral analgesia of the abdomen. The newly emerging, relatively easy erector spinae plane block (ESPB) provided excellent analgesia across a variety of surgical procedures and reduced opioid consumption. This motivated us to do this study to assess and compare the analgesic efficacy of ESPB versus SAQLB following laparoscopic cholecystectomy.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Age 18 - 60 years, of both sexes. 2. ASA class I - III. 3. Scheduled to undergo laparoscopic cholecystectomy under general anesthesia. 4. Body mass index (BMI) = 30 kg/m². Exclusion Criteria: 1. Age < 18 or > 60 years. 2. ASA IV patients. 3. Body mass index (BMI) = 40 kg/m². 4. Intraoperative conversion to open surgery. 5. Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy or infection at the site of injection. 6. Uncooperative patients or psychiatric disorders. 7. Spinal deformity or previous spine surgery. 8. Chronic use of analgesics or drug dependence. chronic pain characterized by opioid use for > 30 consecutive days within the 3 preoperative months at a dose equivalent to at least 15 mg of morphine. |
Country | Name | City | State |
---|---|---|---|
Egypt | Zagazig university hospitals | Zagazig | Sharkia |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24 hours Postoperative Total Opioid Consumption. | 24 hours Postoperative Total Opioid Consumption. | First 24 hours Postoperative | |
Secondary | Time of Performing the Block. | Time from placement of US probe on the patient's skin till the end of local anesthetic injection. | Intraoperative (Time from placement of US probe on the patient's skin till the end of local anesthetic injection.) | |
Secondary | Time of Postoperative First Opioid Analgesic Request. | Time of Postoperative First Opioid Analgesic Request. | First 24 hours Postoperative | |
Secondary | Postoperative NRS Scores | NRS scores recorded 30 min. postoperative, then at 2, 4, 6, 8, 12, 18, and 24 hrs postoperative, during rest and movement. | First 24 hours Postoperative | |
Secondary | Postoperative Complications | including sedation, respiratory depression, PONV, visceral injury, hematoma formation, lower extremity weakness, and LAST. | First 24 hours Postoperative | |
Secondary | Time to First Ambulation. | time until the subject was able to stand up and walk without support. | First 24 hours Postoperative |
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