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Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

Primary Purpose

Postoperative Pain, Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transcutaneous electric nerve stimulation
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Percutaneous Electric Nerve Stimulation, Lumbosacral plexus, surgical wound, postoperative analgesia, transcutaneous electrical stimulation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mustafa Kemal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group I (control)

group II

group III

Arm Description

Patient controlled analgesia (epidural fentanyl): PCA only

PCA plus lumbar plexus & sciatic nerve transcutaneous electric nerve stimulation (LS-TENS)

PCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS)

Outcomes

Primary Outcome Measures

Visual analog scale for pain
Postoperative pain intensity is assessed using VAS for pain postoperatively.

Secondary Outcome Measures

Ramsey sedation scores
Sedation score is assessed for safety of epidural analgesic use.
Frequencies of PCA demand
Patient demand will be assessed by PCA demand
PCA delivery counts
Delivery count shows the actual PCA delivery. It is different from the demand.
Total fentanyl consumption
Total analgesic use during the study period

Full Information

First Posted
December 25, 2015
Last Updated
September 2, 2021
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT02642796
Brief Title
Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain
Official Title
Comparison of the Efficacy of Two Different Transcutaneous Electrical Nerve Stimulation Application Sites in Reducing Postoperative Pain After Hip Fracture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Hip Fracture
Keywords
Percutaneous Electric Nerve Stimulation, Lumbosacral plexus, surgical wound, postoperative analgesia, transcutaneous electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (control)
Arm Type
No Intervention
Arm Description
Patient controlled analgesia (epidural fentanyl): PCA only
Arm Title
group II
Arm Type
Experimental
Arm Description
PCA plus lumbar plexus & sciatic nerve transcutaneous electric nerve stimulation (LS-TENS)
Arm Title
group III
Arm Type
Experimental
Arm Description
PCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS)
Intervention Type
Device
Intervention Name(s)
transcutaneous electric nerve stimulation
Other Intervention Name(s)
Intelect portable TENS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analog scale for pain
Description
Postoperative pain intensity is assessed using VAS for pain postoperatively.
Time Frame
48 h postoperatively
Secondary Outcome Measure Information:
Title
Ramsey sedation scores
Description
Sedation score is assessed for safety of epidural analgesic use.
Time Frame
48 h postoperatively
Title
Frequencies of PCA demand
Description
Patient demand will be assessed by PCA demand
Time Frame
48 h postoperatively
Title
PCA delivery counts
Description
Delivery count shows the actual PCA delivery. It is different from the demand.
Time Frame
48 h postoperatively
Title
Total fentanyl consumption
Description
Total analgesic use during the study period
Time Frame
48 h postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menekse Oksar, M.D.
Organizational Affiliation
Mustafa Kemal University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mustafa Kemal University Hospital
City
Hatay
ZIP/Postal Code
31100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10551571
Citation
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.
Results Reference
result
PubMed Identifier
9249122
Citation
Wang 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 Reference
result
PubMed Identifier
22531569
Citation
Lan 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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/10551571
Description
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.
URL
http://www.ncbi.nlm.nih.gov/pubmed/9249122
Description
High-TAES (9-12 mA) produced a significant decrease in the PCA opioid requirement and opioid-related side effects after low intraabdominal surgery.
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Transcutaneous+electrical+nevre+stimulation+on+acupoints+reduces+fentanyl+requirement+for+postoperative+pain+relief+after+total+hiparthroplasty+in
Description
TENS on specific acupoints is an effective and complementary approach to reduce postoperative analgesic requirement in elderly patients after total hip arthroplasty..

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Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

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