Clinical trial NCT06120088: U.S. Guided Erector Spinae Block for Postoperative Pain Management in Paraumbilical Hernia Repair Patients
Official title: U.S Guided Erector Spinae Block for Postoperative Pain Control in Patients Undergoing Para Umblical Hernial Repair. (Comparative Study ).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Regional Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size was calculated using G power 3.1.9.2. To be able to calculate the difference in first analgesic request between the three studied groups with α error of 0.05, power of study of 0.9, equal group assignment and 0.4 effect size and using ANOVA test for comparison we need to include 27 patients in each group, another 3 patients will be added to each group to compensate for violation at the study protocol.

Brief summary: Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period. Although opioids are commonly used for analgesia after paraumbilical hernia, they can lead to side effects, such as nausea and vomiting, constipation, pruritus, and life-threatening respiratory depression. Regional anesthetic techniques are commonly used to prevent or minimize these side effects. The objective of this study is to assess the effectiveness of erector spinae plane block (ESPB) and standard medical (no block) pain management after paraumbilical hernia.


Eligibility criteria: Inclusion Criteria:

* Age group : 18-60 years old
* Both genders
* Patient scheduled for paraumbilical hernia surgeries

Exclusion Criteria:

* Allergy to medications used in this study
* Patient's refusal to participate in this study
* Recurrent cases
* Any complications to local blocks
* Emergency surgical procedures

Primary outcomes:
measure: first analgesic request
timeFrame: baseline
Secondary outcomes:
measure: VAS score
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
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