Postoperative Pain Clinical Trial
Official title:
The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia of Patients Undergoing Inguinal Hernia Repair: Randomized, Controlled, Double Blinded Trial
NCT number | NCT04300153 |
Other study ID # | 20-II |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 25, 2020 |
Est. completion date | April 8, 2023 |
Verified date | April 2023 |
Source | Mugla Sitki Koçman University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Different pharmacological approaches and interfascial plane blocks are used to control postoperative pain. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was reported to be effective in different types of surgeries. In this study, the primary aim is to assess the effect of ESP on recovery of patients following open IHR surgery.
Status | Completed |
Enrollment | 73 |
Est. completion date | April 8, 2023 |
Est. primary completion date | April 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - American Society of Anesthesiologists physical status I-II - Elective unilateral open inguinal hernia repair under spinal anesthesia Exclusion Criteria: - Coagulation disorder - Known allergy to study drugs - Chronic opioid use - Infection at the injection site - Use of pain medications - Psychologic disorder or inability to cooperate Quality of Recovery-15 (QoR-15) test - Preoperative pain related to inguinal hernia NRS > 4/10 |
Country | Name | City | State |
---|---|---|---|
Turkey | Mugla Sitki Koçman University | Mugla |
Lead Sponsor | Collaborator |
---|---|
Basak Altiparmak | Mugla Sitki Koçman University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global Quality of Recovery-15 score | Global quality of recovery (QoR) score which will be measured by using 15-item QoR-15 questionnaire. This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item) | Postoperative 24th hour | |
Secondary | Numeric Rating Scale (NRS) | A blinded anesthesiologist will assess postoperative pain of the patients during resting and movement at the 1st, 2nd, 4th, 6th, 8th, 12th and 24th hours by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable). | 24 hours | |
Secondary | Rescue analgesia | If Numerical Rating Scale score of the patient is equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Total rescue analgesia need will be recorded. | 24 hours | |
Secondary | Mobilization time | If the patient walks with or without help, it will be accepted as the first mobilization. The motor block duration and time for the first mobilization of the patient will be recorded. | 24 hours |
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