Clinical trial NCT02642796: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Hip Fracture
Keywords: Percutaneous Electric Nerve Stimulation
Lumbosacral plexus
surgical wound
postoperative analgesia
transcutaneous electrical stimulation
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual analog scale for pain
timeFrame: 48 h postoperatively
Secondary outcomes:
measure: Ramsey sedation scores
timeFrame: 48 h postoperatively
measure: Frequencies of PCA demand
timeFrame: 48 h postoperatively
measure: PCA delivery counts
timeFrame: 48 h postoperatively
measure: Total fentanyl consumption
timeFrame: 48 h postoperatively
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Mustafa Kemal University Hospital
Study officials:
affiliation: Mustafa Kemal University Medical School
name: Menekse Oksar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.