Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

NCT02642796 | Completed DMC

• 1 other identifier: 2013/34
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Hip Fracture

Keywords

Percutaneous Electric Nerve Stimulation; Lumbosacral plexus; surgical wound; postoperative analgesia; transcutaneous electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Visual analog scale for pain

  Postoperative pain intensity is assessed using VAS for pain postoperatively.

  48 h postoperatively

Secondary Outcomes (4)

• Ramsey sedation scores

  48 h postoperatively

• Frequencies of PCA demand

  48 h postoperatively

• PCA delivery counts

  48 h postoperatively

• Total fentanyl consumption

  48 h postoperatively

Study Arms (3)

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)

Device: transcutaneous electric nerve stimulation

group III

EXPERIMENTAL

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

Device: transcutaneous electric nerve stimulation

Interventions

transcutaneous electric nerve stimulation DEVICE

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.

Also known as: Intelect portable TENS

group II; group III

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Mustafa Kemal University Hospital

Hatay, 31100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 10551571 RESULT

• 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.

  PMID: 9249122 RESULT

• 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.

  PMID: 22531569 RESULT

• Oksar 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.

  PMID: 38639518 DERIVED

Related Links

• 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.
• High-TAES (9-12 mA) produced a significant decrease in the PCA opioid requirement and opioid-related side effects after low intraabdominal surgery.
• TENS on specific acupoints is an effective and complementary approach to reduce postoperative analgesic requirement in elderly patients after total hip arthroplasty..

MeSH Terms

Conditions

Pain, Postoperative; Hip Fractures; Surgical Wound

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Menekse Oksar, M.D.

  Mustafa Kemal University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 25, 2015
• First Posted: December 30, 2015
• Study Start: March 1, 2013
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)