Post Operative Pain Clinical Trial
Official title:
Effect of Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Obese Patients Undergoing Epigastric Hernia Repair
NCT number | NCT05516901 |
Other study ID # | 34579/3/21 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | July 30, 2022 |
Verified date | August 2022 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to assess the efficacy of ultrasound guided erector Spinae plane block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing Epigastric hernia repair.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 30, 2022 |
Est. primary completion date | July 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - Fifty obese patient BMI (30-40). - Aged (21-65) years ASA (?? and ???) - scheduled for elective Epigastric hernia repair Exclusion Criteria: - Patient refusal to continue the study. - History of allergy to local anesthetics. - Local infection at the site of the block. - Patients with bleeding and coagulation disorders. - Patients with renal, hepatic, cardiac dysfunction, or spine deformities. - Patients with cognitive disorders. - Patients with chronic pulmonary disease. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative pain | Post-operative pain will be assessed by Numeric Rating Scale at recovery room till 24 hours and if NRS?3 morphine 3 mg will be given, total analgesics required will be recorded. | 24 hours postoperatively. | |
Primary | Diaphragmatic dysfunction by physiological parameter | After recovery, patient laid in the supine position and diaphragm movements were recorded in the B-Mode and M-Mode. The probe was positioned between the midclavicular and anterior axillary lines, in the subcostal area, so that the ultrasound beam entered the posterior third of the right hemi diaphragm perpendicularly.
After correct visualization of the right hemidiaphragm by B-mode, M-mode is used to display the motion of the diaphragm. At the end of normal expiration the patient was instructed to inhale as deeply as possible. A fixed point at the edge of the image on the screen and the diaphragm margin at maximal inspiration and again at maximal expiration served as reference points between which measurements were made, with the average of three values being taken for both maximal inspiration and maximal expiration |
24 hours postoperatively. | |
Secondary | Hypotension | defined as decrease blood pressure more than 20% of base line It was treated with rapid IV fluid infusion (100ml over 1 minutes) and bolus ephedrine 5-15 mg if needed. | 24 hours postoperatively | |
Secondary | Bradycardia | Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg | 24 hours postoperatively |
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