Postoperative PainNCT07621744
Parasternal Block Versus Wound Infiltration for Pain After Median Sternotomy:A Salivary Opiorphin-Based Study
A study testing Parasternal blocks and Wound Site Infiltration in people with Postoperative Pain and Cardiac Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Postoperative Pain, Cardiac Surgery, Median Sternotomy
- What is being tested?
- Parasternal blocks and Wound Site Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for surgery through median sternotomy
- Patients who provided informed consent
Who cannot join
- Age under 30 years
- Presence of ischemic, inflammatory, or systemic disease, except cardiovascular disease
- Use of analgesic medication within the last 24 hours
- Diagnosis of psychiatric disorder
- Presence of any oral pathology, including active dental caries, aphthous lesions, or salivary gland inflammation
- Prolonged intubation or inability to be separated from mechanical ventilation for more than 8 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effect of Parasternal Block Versus Wound Site Infiltration on Postoperative Pain Levels by Salivary Opiorphin Levels in Patients Undergoing Median Sternotomy: A Randomized Prospective Study
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.
Read the detailed description
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.
- Conditions
- Postoperative Pain, Cardiac Surgery, Median Sternotomy
- Being tested
- Parasternal blocks, Wound Site Infiltration
- Keywords
- Parasternal Block, Wound Site Infiltration, Opiorphin, Median Sternotomy, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal blocksProcedure or surgery
Ultrasound-guided parasternal block was performed with local anesthetic before surgical incision.
Wound Site InfiltrationProcedure or surgery
Local anesthetic infiltration was performed at the surgical wound site before surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Parasternal blocks |
| 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. Receives: Procedure: Wound Site Infiltration |
| Standard Analgesia Group | No intervention | Participants in this group received standard perioperative systemic analgesia without local anesthetic intervention at the surgical site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Opiorphin Level
Salivary opiorphin levels were measured using ELISA to evaluate the analgesic effect of the study interventions.
Measured: Baseline, 3 minutes after sternotomy, and postoperative 6 hours
Secondary outcomes (6)
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.
Measured: At 1, 2, 4, 8, 12, and 24 hours after extubation
Additional Analgesic Requirement
The need for rescue analgesia was recorded during the postoperative follow-up period.
Measured: Within the first 24 hours after extubation
Total Opioid Consumption
Total opioid consumption delivered by patient-controlled analgesia was recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of three parallel groups: parasternal block, wound site infiltration, or standard systemic analgesia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Akif Yilmaz, Ataturk University
- Investigators
- Muhammed Enes Aydin, professor, Study director, Ataturk University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621744
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/353
- Other IDs
- 2023/2
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Publications
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.
PubMed 29247820Ozdogan 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.
PubMed 30590229Gavcar 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.
PubMed 35636040Yilmaz 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.
PubMed 36412293
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Parasternal Block Versus Wound Site Infiltration on Postoperative Pain Levels by Salivary Opiorphin Levels in Patients Undergoing Median Sternotomy: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07621744
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/353
- Conditions
- Postoperative Pain, Cardiac Surgery, Median Sternotomy
- Keywords
- Parasternal Block, Wound Site Infiltration, Opiorphin, Median Sternotomy, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were assigned to one of three parallel groups: parasternal block, wound site infiltration, or standard systemic analgesia.
| Arm | Type | Receives |
|---|---|---|
| Parasternal Block Group | Experimental | Procedure: Parasternal blocksParticipants 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 | Procedure: Wound Site InfiltrationParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for surgery through median sternotomy
- Patients who provided informed consent
Key exclusion criteria (6 listed)
- Age under 30 years
- Presence of ischemic, inflammatory, or systemic disease, except cardiovascular disease
- Use of analgesic medication within the last 24 hours
- Diagnosis of psychiatric disorder
- Presence of any oral pathology, including active dental caries, aphthous lesions, or salivary gland inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasternal blocksUltrasound-guided parasternal block was performed with local anesthetic before surgical incision. | Procedure or surgery | Parasternal Block Group |
| Wound Site InfiltrationLocal anesthetic infiltration was performed at the surgical wound site before surgical incision. | Procedure or surgery | Wound Site Infiltration Group |
Primary outcome
Change in Salivary Opiorphin Level
Time frame: Baseline, 3 minutes after sternotomy, and postoperative 6 hours
Salivary opiorphin levels were measured using ELISA to evaluate the analgesic effect of the study interventions.
6 secondary outcomes
Postoperative Pain Intensity Assessed by the Visual Analogue Scale
Time frame: At 1, 2, 4, 8, 12, and 24 hours after extubation
Additional Analgesic Requirement
Time frame: Within the first 24 hours after extubation
Total Opioid Consumption
Time frame: Within the first 24 postoperative hours
Extubation Time
Time frame: Immediately after surgery until tracheal extubation, assessed up to 24 hours postoperatively
Intensive Care Unit Length of Stay
Time frame: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperatively
Postoperative Nausea and Vomiting
Time frame: Within the first 24 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 29247820Parida 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.
- Background: PubMed 30590229Ozdogan 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.
- Background: PubMed 35636040Gavcar 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.
- Background: PubMed 36412293Yilmaz 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed Enes Aydin, professor study director
Ataturk University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasternal blocks and Wound Site Infiltration in people with Postoperative Pain and Cardiac Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Opiorphin Level (time frame: Baseline, 3 minutes after sternotomy, and postoperative 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07621744, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.