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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/2 | Other Identifier | Atatürk University Clinical Research Ethics Committee |
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This study evaluated the effects of parasternal block and wound site infiltration on postoperative pain in patients undergoing median sternotomy. Patients were allocated to receive parasternal block, wound site infiltration, or standard systemic analgesia. Salivary opiorphin levels and postoperative pain scores were assessed to compare analgesic effectiveness between the groups.
This randomized prospective study included patients undergoing surgery through median sternotomy. The study compared three perioperative analgesic approaches: parasternal block, wound site infiltration, and standard systemic analgesia without local intervention at the surgical site.
Salivary samples were collected before surgery, after sternotomy, and during the postoperative period to measure opiorphin levels. Postoperative pain was assessed using visual analogue scale scores, and additional analgesic requirement, opioid consumption, extubation time, intensive care unit stay, and adverse effects such as nausea and vomiting were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parasternal Block Group | Experimental | Participants in this group received ultrasound-guided parasternal block with local anesthetic before surgical incision, in addition to standard perioperative systemic analgesia. |
|
| Wound Site Infiltration Group | Active Comparator | Participants in this group received wound site infiltration with local anesthetic before surgical incision, in addition to standard perioperative systemic analgesia. |
|
| Standard Analgesia Group | No Intervention | Participants in this group received standard perioperative systemic analgesia without local anesthetic intervention at the surgical site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasternal blocks | Procedure | Ultrasound-guided parasternal block was performed with local anesthetic before surgical incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Salivary Opiorphin Level | Salivary opiorphin levels were measured using ELISA to evaluate the analgesic effect of the study interventions. | Baseline, 3 minutes after sternotomy, and postoperative 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity Assessed by the Visual Analogue Scale | Postoperative pain intensity was assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse postoperative pain. | At 1, 2, 4, 8, 12, and 24 hours after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammed Enes Aydin, professor | Ataturk University Department of Anesthesiology and Reanimation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University | Erzurum | 25240 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29247820 | Background | Parida SK, Guruprasad T, Krishnakumar VB, Ravi RP. A study of salivary opiorphin levels using different anesthetic drugs and techniques - A randomized controlled clinical study. J Stomatol Oral Maxillofac Surg. 2018 Jun;119(3):169-171. doi: 10.1016/j.jormas.2017.11.017. Epub 2017 Dec 13. | |
| 30590229 | Background |
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Individual participant data will not be shared due to participant privacy and confidentiality considerations.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Participants were assigned to one of three parallel groups: parasternal block, wound site infiltration, or standard systemic analgesia.
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Participants and postoperative outcome assessors were blinded to group assignment. In addition, laboratory personnel performing salivary opiorphin measurements were blinded to treatment allocation.
| Wound Site Infiltration | Procedure | Local anesthetic infiltration was performed at the surgical wound site before surgical incision. |
|
| Additional Analgesic Requirement |
The need for rescue analgesia was recorded during the postoperative follow-up period. |
| Within the first 24 hours after extubation |
| Total Opioid Consumption | Total opioid consumption delivered by patient-controlled analgesia was recorded. | Within the first 24 postoperative hours |
| Extubation Time | Time to extubation was defined as the duration from the end of surgery to tracheal extubation and was recorded in minutes. | Immediately after surgery until tracheal extubation, assessed up to 24 hours postoperatively |
| Intensive Care Unit Length of Stay | Intensive care unit length of stay was defined as the duration from admission to the intensive care unit after surgery until discharge from the intensive care unit and was recorded in hours. | From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperatively |
| Postoperative Nausea and Vomiting | Postoperative nausea and vomiting were recorded as adverse effects. | Within the first 24 postoperative hours |
| Ozdogan MS, Gungormus M, Ince Yusufoglu S, Ertem SY, Sonmez C, Orhan M. Salivary opiorphin in dental pain: A potential biomarker for dental disease. Arch Oral Biol. 2019 Mar;99:15-21. doi: 10.1016/j.archoralbio.2018.12.006. Epub 2018 Dec 15. |
| 35636040 | Background | Gavcar EG, Kabukcu Basay B, Avci E, Basay O. Relationship between saliva opiorphin levels, pain threshold, and cutting number in adolescents with non suicidal self injury. J Psychiatr Res. 2022 Jul;151:611-618. doi: 10.1016/j.jpsychires.2022.05.030. Epub 2022 May 24. |
| 36412293 | Background | Yilmaz N, Baygin O, Tuzuner T, Mentese A, Demir S. Determination of the effect of two different methods of dental anesthesia on pain level in pediatric patients: A cross-over, randomized trial. Niger J Clin Pract. 2022 Nov;25(11):1853-1863. doi: 10.4103/njcp.njcp_289_22. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |