Evaluation of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Upper GI Laparoscopy Surgeries: A Prospective, Randomized, Controlled Clinical Trial (ESP)
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|ClinicalTrials.gov Identifier: NCT04368195|
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : February 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Procedure: Erector spinae block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised controlled trial|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind|
|Official Title:||Evaluation of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Upper GI Laparoscopy Surgeries: A Prospective, Randomized, Controlled Clinical Trial|
|Actual Study Start Date :||December 30, 2020|
|Actual Primary Completion Date :||December 30, 2022|
|Actual Study Completion Date :||December 30, 2022|
No Intervention: Control group
This group will not receive any regional block
Experimental: Erector spinae block group
This group will receive erector spinae block
Procedure: Erector spinae block
Erector Spinae Plane Block (ESPB) - first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries (10-12). In ESPB, local anesthetic is reported to be administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces.
- NRS pain score at 18th hours [ Time Frame: 18th hour ]Primary outcome measures at commencement of the study will be NRS pain score at 18th hours postoperatively both at rest and when coughing.
- Analgesic consumption [ Time Frame: 24 hours ]Secondary outcome measures will be routine (paracetamol or morphine PCA) or rescue analgesic use within the ﬁrst 24h.
- Adverse events [ Time Frame: 24 hours ]Adverse events like shoulder pain during the ﬁrst 24 h and presence of postoperative nausea and vomiting will be noted. The severity of both nausea and sedation will be assessed by patients on a 4 point scale (none, mild, moderate, and severe).
- NRS pain score at other time intervals [ Time Frame: 0-24 hours ]NRS pain scores will also be measured at 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours and 24 hours postoperatively
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients aged between 18 and 65years, scheduled to undergo any upper GI laparoscopy surgeries with an ASA score of 1 or 2 will be included in the study. The surgeries included in this group include laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic umblical or epigastric hernia repair.
Written informed consent for general anesthesia and all procedures will be obtained from all patients.
- Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications and conversion to open laparotomy will not be included in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368195
|Security Forces Hospital Program|
|Riyadh, Saudi Arabia, 11|
|Security Forces Hospital|
|Riyadh, Saudi Arabia, 11|
|Responsible Party:||Anwar ul Huda, Consultant Anaesthetist, Security Forces Hospital|
|Other Study ID Numbers:||
|First Posted:||April 29, 2020 Key Record Dates|
|Last Update Posted:||February 23, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||On request|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||1 year|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Erector spinae block
Upper GI laparoscopy