Clinical trial · Interventional
Efficacy of PENS of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients
Efficacy of Percutaneous Electrical Neurostimulation (PENS)of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pain relief following laparotomy surgery requires a variety of techniques including invasive ones like epidural or nerve blocks along with different classes of drugs, out of which opioids are most predominant. Each of these drugs have with their own set of advantages and also side effects. An ideal common system of analgesia is not possible due to patient variability. And no drug is devoid of side effects. Hence the aim is to ensure effective analgesia using drugs or techniques which are minimally invasive with negligible side effects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Cervix | Malignant Cervical Neoplasm | ALIAS | 0.90 |
| Cancer of Endometrium | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary Relief | Device | — | UNRESOLVED |
| Primary Relief - Sham Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- The group who have received PENS treatment using PrimaryRelief in addition to Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS\>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.
- interventionNames
- Device: Primary Relief
- type
- SHAM_COMPARATOR
- label
- Control Group
- description
- The group who have received a sham device along with Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS\>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.
- interventionNames
- Device: Primary Relief - Sham Device
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 yrs * Diagnosed with CA-endometrium OR CA -cervix of stage I/II and post RT CA cervix patients coming for hysterectomy * Elective surgery * Informed consent obtained * ASA (American Society of Anaesthesiology) physical status 1-3 Exclusion Criteria: * Patient refusal * Cancer cervix other than the stages mentioned in inclusion criteria ASA PS \>3 * Emergency surgery, Laparoscopic and robotic procedures * Unplanned postoperative ventilation * Allergy/sensitivity to adhesive * Active skin infection/lesion in the ear region * H/O of seizure or cerebral disease * H/O chronic pain and prolonged analgesic usage * H/O opioid dependence * H/O anxiety or psychiatric illness requiring treatment * Pre-existing implantable/ electronic on demand device * Patients who might require MRI in the study period * Patients with transmissible diseases * Patients with coagulopathies * Absolute or relative contraindication to drugs used in the study
References
Publications (2)
- RESULTArponrat P, Pongrojpaw D, Tanprasertkul C, Suwannarurk K, Bhamarapravatana K. Postoperative Pain Relief in Major Gynaecological Surgery by Perioperative Parecoxib Administration: Thammasat University Hospital Study. J Med Assoc Thai. 2015 Jul;98(7):636-42. PMID 26267984
- RESULTPogatzki-Zahn E, Kutschar P, Nestler N, Osterbrink J. A Prospective Multicentre Study to Improve Postoperative Pain: Identification of Potentialities and Problems. PLoS One. 2015 Nov 24;10(11):e0143508. doi: 10.1371/journal.pone.0143508. eCollection 2015. PMID 26600464