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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.
Efficient post operative pain relief is an essential part of comprehensive recovery of patients. Conventional method of pain management of laparotomy surgeries in CA endometrium and cervix patients involves invasive techniques like epidural or selective nerve block coupled with a varied choice of analgesics like opioids, NSAID or acetaminophen, wherein each drug is associated with its own set of contraindications and side effects. Despite advances in analgesic regimen including multimodal analgesic regimen, opioids have been observed to remain the mainstay postoperative analgesia in cancer patients despite its well-established side effects.
This double-blinded prospective interventional study is conducted to explore the alternative of percutaneous electrical nerve stimulation (PENS) devices for effective pain relief with minimal to no side-effects.
The device will have tiny needles and a battery system that will be placed on and behind the patient's ear when they are under anesthesia.
It acts by stimulating nerves around ear region by series of pain free impulse generation leading to centrally (brain) mediated response by altering certain chemical substances responsible for causing pain thereby providing relief for the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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. |
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| Control Group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Relief | Device | Continuous neurostimulation with a set of pre-assigned stimulation parameters. |
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| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) | The primary goal is to evaluate the efficacy of PENS treatment in the change in postoperative pain after cancer surgery compared to the control group. The pain is measured using the numerical rating scale (NRS). Pain Score will be measured on a scale (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome) | 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. Outcomes will be reported as an average over each individual postoperative day and as an average over 5 days independently for rest. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Postoperative analgesia and opioid requirement | To evaluate the effect of treatment in reducing the overall postoperative analgesia and opioid requirement. We will record the total dose and duration of additional analgesics required from the immediate postoperative period till pod 4 in iv morphine equivalents. | 0 - 4 days, duration and dose of all prescriptions are recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Sahithya Sriman, MBBS, MD | Cancer Institue, WIA, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute,(Wia) | Chennai | Tamil Nadu | 600020 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26267984 | Result | Arponrat 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. | |
| 26600464 | Result | Pogatzki-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. |
| Label | URL |
|---|---|
| Pattern of use of analgesics in post-operative pain management in adults undergoing laparotomy surgery: a prospective observational study | View source |
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| Primary Relief - Sham Device | Device | Standard treatment with the application of sham device shall be followed with additional analgesics available if necessary. |
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| Patient Ambulation | Evaluate the ease of patient ambulation by assessing associated Numeric Rating Scale (NRS) score (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome) | 1 - 4 days; 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. |
| Record of Participant Bowel Movement Patterns | Onset of Bowel Movements - POD 1/POD 2/ POD 3/ > POD3 | 0 - 4 days; Whenever the patient experiences the bowel movement. |
| Richmond Agitation Sedation Scale (RASS) | Compare Richmond Agitation Sedation Scale (RASS) score at a different time point during the follow-up time. RASS score will be measured on a scale (from -5 = Unarousable to +4 = Combative where 0 = Alert and calm) | 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. |
| Patient Discomfort | Patient Discomfort due to device (Yes / no) | Time Frame: 0 - 4 days; Whenever the patient experiences the discomfort. |
| Bleeding | Bleeding at the site of device placement (Yes / No) | Time Frame: 0 - 4 days; Whenever the patient experiences bleeding. |
| Interference with Daily Activities | Interference with activities of daily living due to the device (Yes/No) | Time Frame: 0 - 4 days; Whenever the patient experiences disruption in daily activities. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
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