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Patient-controlled transcutaneous electrical nerve stimulation for postoperative pain after abdominal surgery: a randomized pilot trial in an enhanced recovery after surgery hospital

Patient-controlled transcutaneous electrical nerve stimulation for postoperative pain after abdominal surgery: a randomized pilot trial in an enhanced recovery after surgery hospital

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001140145
Enrollment
10
Registered
2019-08-15
Start date
2019-10-15
Completion date
2020-01-14
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main aim of this study is to perform a pilot trial to determine if patient-controlled TENS applied in the immediate postoperative period is feasible and tolerable for patients undergoing major abdominal surgery within an ERAS protocol for the reduction of opioid use, pain, and the improvement of surgical recovery outcomes. Our hypothesis is that TENS is a patient-tolerable intervention with little to no side effects. We predict TENS will be easy and safe for patients to use. Although this study will not be powered for testing efficacy of TENS, we hypothesise that TENS when applied with enough stimulation intensity will be effective in reducing postoperative opioid use.

Interventions

Patients will be allocated into 2 groups, both receiving the intervention at different intensities. Group 1 will have TENS applied and titrated to a stimulation intensity that is the maximal tolerable by the patient without being painful or inducing muscle contraction. Stimulation intensity set by each individual patient at the start of each session whereby patients will titrate it up. Once patients are satisfied with intensity, patients will be instructed not to change it for the rest of the se

Patients will be allocated into 2 groups, both receiving the intervention at different intensities. Group 1 will have TENS applied and titrated to a stimulation intensity that is the maximal tolerable by the patient without being painful or inducing muscle contraction. Stimulation intensity set by each individual patient at the start of each session whereby patients will titrate it up. Once patients are satisfied with intensity, patients will be instructed not to change it for the rest of the session. It is anticipated final intensity will be approximately 30mA based on previous studies but this will vary depending on what the patient deems non-painful. There is no minimum/maximum intensity provided. After the patient is taught how to administer the treatment by a study investigator, the patient will self-administer the treatment postoperatively. Patients will receive a TENS unit providing an asymmetric square biphasic wave form at a frequency of 80 pulses/s and a pulse width of 250 µs. TENS will be applied starting 1 hour post-surgery once patients are awake and alert, with each session applied for a duration of 30 minutes for the first 48hours postoperatively. Patients will be instructed to apply the TENS when they feel pain for pre-set 30-minute durations. Patients can terminate the session early if they experience discomfort or want to; we will ask patients to record events like this. The intervention will occur on the hospital recovery ward. Patients will be given a written form to track the intensity, timing and duration of each application. The TENS machine will be modified so only intensity can be changed to prevent tampering. Patients and the TENS unit will be checked on twice daily to monitor adherence.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

- Patients undergoing open or laparoscopic (with an extraction site via a mini-laparotomy) abdominal surgery at Auckland District Health Board - Able to understand risks and benefits of participating in the study - Ability to provide informed consent

Exclusion criteria

- Prior TENS use preventing adequate study group blinding - Current pregnancy - Epilepsy or prior history of seizures - History of cardiac disease - Implantable medical device such as pacemaker or implantable defibrillator - ASA Grade IV or greater - Inability to participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium - Inability to operate TENS device by themselves

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026