Postoperative PainNCT02642796
Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain
A study testing transcutaneous electric nerve stimulation in people with Postoperative Pain and Hip Fracture, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Pain, Hip Fracture
- What is being tested?
- transcutaneous electric nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to 1 Sep 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Adult patients will be scheduled for surgery due to hip fracture in Mustafa Kemal University Hospital will be included in the study.
Exclusion Criteria: Patients with a history of opioid analgesic abuse, or sensitivity to opioids, and those with clinically significant systemic (cardiovascular, pulmonary, hepatic, renal, neurologic etc.) diseases, will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa Kemal University Hospital
Hatay, 31100
About this study
Official title: Comparison of the Efficacy of Two Different Transcutaneous Electrical Nerve Stimulation Application Sites in Reducing Postoperative Pain After Hip Fracture Surgery
Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.
Read the detailed description
The patients underwent undergo fractured hip surgery will be distributed into three groups with respect to the mode of postoperative analgesia applied: Group I (control): PCA only; group II: PCA plus lumbar plexus \& sciatic nerve TENS (LS-TENS); group III: PCA plus surgical wound TENS (SW-TENS). TENS will be applied every 2 hours for 30-40 minutes during 48 hours postoperatively. Visual analogue score (VAS), Ramsey sedation scores, frequencies of PCA demand and counts of PCA delivery, as well as total analgesic consumption will be noted and compared between groups at various time intervals.
Visual analog scale (VAS) will be applied at 2 months postoperatively VAS and Mcgill pain questionnaire will be applied at the 6th and 24th months of the surgery to assess acute and chronic pain in the study population and the differences among groups.
- Conditions
- Postoperative Pain, Hip Fracture
- Being tested
- transcutaneous electric nerve stimulation
- Keywords
- Percutaneous Electric Nerve Stimulation, Lumbosacral plexus, surgical wound, postoperative analgesia, transcutaneous electrical stimulation
- Medical subject headings
- Pain, Postoperative, Hip Fractures, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electric nerve stimulationDevice
Also called Intelect portable TENS
The TENS device will be applied for treatment periods of 30-40 minutes. The electrodes will be connected to the TENS device are stimulated in modulation mode and the parameters will be adjusted as pulse width of 60 μs,frequency of 120 Hz and the stimulation intensity as high as the subject could tolerate.
Electrodes will be placed on either lumbar and sciatic nerve tracing unilaterally or on either side or parallel to the surgical wound.
| Study group | Role | What they receive |
|---|---|---|
| Group I (control) | No intervention | Patient controlled analgesia (epidural fentanyl): PCA only |
| group II | Experimental | PCA plus lumbar plexus \& sciatic nerve transcutaneous electric nerve stimulation (LS-TENS) Receives: Device: transcutaneous electric nerve stimulation |
| group III | Experimental | PCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS) Receives: Device: transcutaneous electric nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale for pain
Postoperative pain intensity is assessed using VAS for pain postoperatively.
Measured: 48 h postoperatively
Secondary outcomes (4)
Ramsey sedation scores
Sedation score is assessed for safety of epidural analgesic use.
Measured: 48 h postoperatively
Frequencies of PCA demand
Patient demand will be assessed by PCA demand
Measured: 48 h postoperatively
PCA delivery counts
Delivery count shows the actual PCA delivery. It is different from the demand.
Measured: 48 h postoperatively
Total fentanyl consumption
Total analgesic use during the study period
Measured: 48 h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startMar 2013
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MENEKSE OKSAR, Mustafa Kemal University
- Investigators
- Menekse Oksar, M.D., Principal investigator, Mustafa Kemal University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642796
- Sponsor's protocol ID
- 2013/34
- Status last verified
- Sep 2021
- First submitted
- 25 Dec 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hamza MA, White PF, Ahmed HE, Ghoname EA. Effect of the frequency of transcutaneous electrical nerve stimulation on the postoperative opioid analgesic requirement and recovery profile. Anesthesiology. 1999 Nov;91(5):1232-8. doi: 10.1097/00000542-199911000-00012.
PubMed 10551571Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
PubMed 9249122Lan F, Ma YH, Xue JX, Wang TL, Ma DQ. Transcutaneous electrical nerve stimulation on acupoints reduces fentanyl requirement for postoperative pain relief after total hip arthroplasty in elderly patients. Minerva Anestesiol. 2012 Aug;78(8):887-95. Epub 2012 Apr 24.
PubMed 22531569Oksar M, Kalaci A, Turhanoglu S. Transcutaneous electrical nerve stimulation for reducing postoperative acute pain after hip fracture surgery: a double-blinded randomized clinical trial. Eur Rev Med Pharmacol Sci. 2024 Apr;28(7):2788-2796. doi: 10.26355/eurrev_202404_35907.
PubMed 38639518
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Two Different Transcutaneous Electrical Nerve Stimulation Application Sites in Reducing Postoperative Pain After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT02642796
- Acronym / sponsor ID
- 2013/34
- Conditions
- Postoperative Pain, Hip Fracture
- Keywords
- Percutaneous Electric Nerve Stimulation, Lumbosacral plexus, surgical wound, postoperative analgesia, transcutaneous electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 30 Dec 2015 (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.
Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.
Detailed description
The patients underwent undergo fractured hip surgery will be distributed into three groups with respect to the mode of postoperative analgesia applied: Group I (control): PCA only; group II: PCA plus lumbar plexus \& sciatic nerve TENS (LS-TENS); group III: PCA plus surgical wound TENS (SW-TENS). TENS will be applied every 2 hours for 30-40 minutes during 48 hours postoperatively. Visual analogue score (VAS), Ramsey sedation scores, frequencies of PCA demand and counts of PCA delivery, as well as total analgesic consumption will be noted and compared between groups at various time intervals.
Visual analog scale (VAS) will be applied at 2 months postoperatively VAS and Mcgill pain questionnaire will be applied at the 6th and 24th months of the surgery to assess acute and chronic pain in the study population and the differences among groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (control) | No intervention | –Patient controlled analgesia (epidural fentanyl): PCA only |
| group II | Experimental | Device: transcutaneous electric nerve stimulationPCA plus lumbar plexus \& sciatic nerve transcutaneous electric nerve stimulation (LS-TENS) |
| group III | Experimental | Device: transcutaneous electric nerve stimulationPCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| transcutaneous electric nerve stimulationAlso: Intelect portable TENSThe TENS device will be applied for treatment periods of 30-40 minutes. The electrodes will be connected to the TENS device are stimulated in modulation mode and the parameters will be adjusted as pulse width of 60 μs,frequency of 120 Hz and the stimulation intensity as high as the subject could tolerate. Electrodes will be placed on either lumbar and sciatic nerve tracing unilaterally or on either side or parallel to the surgical wound. | Device | group II, group III |
Primary outcome
Visual analog scale for pain
Time frame: 48 h postoperatively
Postoperative pain intensity is assessed using VAS for pain postoperatively.
4 secondary outcomes
Ramsey sedation scores
Time frame: 48 h postoperatively
Frequencies of PCA demand
Time frame: 48 h postoperatively
PCA delivery counts
Time frame: 48 h postoperatively
Total fentanyl consumption
Time frame: 48 h postoperatively
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 5 Sep 2021.
- Results publication: PubMed 10551571Hamza MA, White PF, Ahmed HE, Ghoname EA. Effect of the frequency of transcutaneous electrical nerve stimulation on the postoperative opioid analgesic requirement and recovery profile. Anesthesiology. 1999 Nov;91(5):1232-8. doi: 10.1097/00000542-199911000-00012.
- Results publication: PubMed 9249122Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
- Results publication: PubMed 22531569Lan F, Ma YH, Xue JX, Wang TL, Ma DQ. Transcutaneous electrical nerve stimulation on acupoints reduces fentanyl requirement for postoperative pain relief after total hip arthroplasty in elderly patients. Minerva Anestesiol. 2012 Aug;78(8):887-95. Epub 2012 Apr 24.
- Derived from this study: PubMed 38639518Oksar M, Kalaci A, Turhanoglu S. Transcutaneous electrical nerve stimulation for reducing postoperative acute pain after hip fracture surgery: a double-blinded randomized clinical trial. Eur Rev Med Pharmacol Sci. 2024 Apr;28(7):2788-2796. doi: 10.26355/eurrev_202404_35907.
- Use of TENS at mixed (2- and 100-Hz) frequencies of stimulation produced a slightly greater opioid-sparing effect than either low (2-Hz) or high (100 Hz) frequencies alone.Link provided by the sponsor.
- High-TAES (9-12 mA) produced a significant decrease in the PCA opioid requirement and opioid-related side effects after low intraabdominal surgery.Link provided by the sponsor.
- TENS on specific acupoints is an effective and complementary approach to reduce postoperative analgesic requirement in elderly patients after total hip arthroplasty..Link provided by the sponsor.
- 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.
Menekse Oksar, M.D. principal investigator
Mustafa Kemal University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electric nerve stimulation in people with Postoperative Pain and Hip Fracture, run by Mustafa Kemal 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?
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 5 Sep 2021. 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 analog scale for pain (time frame: 48 h postoperatively). 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 NCT02642796, 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 5 Sep 2021.