Postoperative PainNCT02725229
Parasternal Block and TENS for Cardiac Surgery
A study testing parasternal block and TENS group in people with Postoperative Pain, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
the objective of the present study was to compare the efficacy of TENS and parasternal block with local anesthetic infiltration in relieving pain during the first 24 h period following median sternotomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- parasternal block and TENS group
- Type of treatment
- Medical device, 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
- Jun 2011to Dec 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age,
- who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass
Who cannot join
- previous sternotomy for CABG or heart valve surgery; emergency surgery
- ejection fraction <40%
- congestive heart failure
- an allergy to amide-based local anesthetics, opioids or benzodiazepines
- inability to provide informed consent
- prolonged cardiopulmonary bypass time (>145 min)
- previous experience with TENS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management After Cardiac Surgery
the objective of the present study was to compare the efficacy of TENS and parasternal block with local anesthetic infiltration in relieving pain during the first 24 h period following median sternotomy.
Read the detailed description
Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions and the inability to cough due to median sternotomy. Invasive and noninvasive interventions such as epidural analgesia, local regional blockade and the use of intravenous (IV) opioids, are used for postoperative pain management. Transcutaneous electrical nerve stimulation (TENS) is a noninvasive technique that is effective for postoperative pain management. It has been demonstrated to produce effective analgesia and reduce postoperative opioid requirements in patients undergoing cardiac surgery, and it has no side effects. Parasternal local anesthetic infiltration around the sternum has been demonstrated to be useful in providing early postoperative analgesia, reducing opioid requirements and, therefore, producing a potential positive effect on recovery. The present prospective, randomized controlled study included 120 patients, 18 to 65 years of age, who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. A random number table was used to randomly allocate patients to one of three treatment groups to relieve postoperative pain during the first 24 h following median sternotomy: parasternal block group (parasternal block combined with levobupivacaine infiltration and PCA(patient controlled analgesia)); TENS group (TENS and PCA); or the control group (PCA alone).
- Conditions
- Postoperative Pain
- Being tested
- parasternal block, TENS group, control group
- Keywords
- Postoperative pain, Parasternal block, Sternotomy, TENS
- 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 blockProcedure or surgery
Also called Levobupivacaine
parasternal block and PCA for sternotomy pain
TENS groupDevice
Also called TENS device
TENS and PCA for sternotomy pain
control groupDevice
Also called PCA device
PCA for sternotomy pain
| Study group | Role | What they receive |
|---|---|---|
| parasternal block group | Active comparator | Patients in this group will be randomized to receive an parasternal block and PCA. Receives: Procedure: parasternal block |
| TENS group | Active comparator | Patients in this group will be randomized to receive an TENS and PCA. Receives: Device: TENS group |
| control group | Active comparator | Patients in this group will be randomized to receive an PCA. Receives: Device: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scores
Measured: Assessed 24 hours after to intensive care unit admission
Secondary outcomes (5)
Supplemental morphine used
Measured: Assessed 24 hours after to intensive care unit admission
Extubation time
Measured: Assessed 24 hours after to intensive care unit admission
Length of ICU stay
Measured: Assessed 24 hours after to intensive care unit admission
Length of hospital stay
Measured: Assessed 10 days after to intensive care unit admission
Supplemental tramadol used
Measured: Assessed 24 hours after to intensive care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJun 2011
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nilgun Kavrut Ozturk, MD, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725229
- Sponsor's protocol ID
- AntalyaTRH 011
- Status last verified
- Mar 2016
- First submitted
- 23 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ozturk NK, Baki ED, Kavakli AS, Sahin AS, Ayoglu RU, Karaveli A, Emmiler M, Inanoglu K, Karsli B. Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management after Cardiac Surgery. Pain Res Manag. 2016;2016:4261949. doi: 10.1155/2016/4261949. Epub 2016 Apr 12.
PubMed 27445610
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02725229
- Acronym / sponsor ID
- AntalyaTRH 011
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Parasternal block, Sternotomy, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jun 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
the objective of the present study was to compare the efficacy of TENS and parasternal block with local anesthetic infiltration in relieving pain during the first 24 h period following median sternotomy.
Detailed description
Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions and the inability to cough due to median sternotomy. Invasive and noninvasive interventions such as epidural analgesia, local regional blockade and the use of intravenous (IV) opioids, are used for postoperative pain management. Transcutaneous electrical nerve stimulation (TENS) is a noninvasive technique that is effective for postoperative pain management. It has been demonstrated to produce effective analgesia and reduce postoperative opioid requirements in patients undergoing cardiac surgery, and it has no side effects. Parasternal local anesthetic infiltration around the sternum has been demonstrated to be useful in providing early postoperative analgesia, reducing opioid requirements and, therefore, producing a potential positive effect on recovery. The present prospective, randomized controlled study included 120 patients, 18 to 65 years of age, who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. A random number table was used to randomly allocate patients to one of three treatment groups to relieve postoperative pain during the first 24 h following median sternotomy: parasternal block group (parasternal block combined with levobupivacaine infiltration and PCA(patient controlled analgesia)); TENS group (TENS and PCA); or the control group (PCA alone).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| parasternal block group | Active comparator | Procedure: parasternal blockPatients in this group will be randomized to receive an parasternal block and PCA. |
| TENS group | Active comparator | Device: TENS groupPatients in this group will be randomized to receive an TENS and PCA. |
| control group | Active comparator | Device: control groupPatients in this group will be randomized to receive an PCA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 65 years of age,
- who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass
Key exclusion criteria (7 listed)
- previous sternotomy for CABG or heart valve surgery; emergency surgery
- ejection fraction <40%
- congestive heart failure
- an allergy to amide-based local anesthetics, opioids or benzodiazepines
- inability to provide informed consent
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 blockAlso: Levobupivacaineparasternal block and PCA for sternotomy pain | Procedure or surgery | parasternal block group |
| TENS groupAlso: TENS deviceTENS and PCA for sternotomy pain | Device | TENS group |
| control groupAlso: PCA devicePCA for sternotomy pain | Device | control group |
Primary outcome
Visual Analogue Scores
Time frame: Assessed 24 hours after to intensive care unit admission
5 secondary outcomes
Supplemental morphine used
Time frame: Assessed 24 hours after to intensive care unit admission
Extubation time
Time frame: Assessed 24 hours after to intensive care unit admission
Length of ICU stay
Time frame: Assessed 24 hours after to intensive care unit admission
Length of hospital stay
Time frame: Assessed 10 days after to intensive care unit admission
Supplemental tramadol used
Time frame: Assessed 24 hours after to intensive care unit admission
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 31 Mar 2016.
- Derived from this study: PubMed 27445610Ozturk NK, Baki ED, Kavakli AS, Sahin AS, Ayoglu RU, Karaveli A, Emmiler M, Inanoglu K, Karsli B. Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management after Cardiac Surgery. Pain Res Manag. 2016;2016:4261949. doi: 10.1155/2016/4261949. Epub 2016 Apr 12.
- Individual participant dataSharing planned: No
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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.
Nilgun Kavrut Ozturk, MD study director
Antalya Training and Research Hospital
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 block and TENS group in people with Postoperative Pain, run by Antalya Training and Research Hospital 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 7 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 31 Mar 2016. 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?
Visual Analogue Scores (time frame: Assessed 24 hours after to intensive care unit admission). 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 NCT02725229, which also lists 1 linked publication.
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 31 Mar 2016.