The Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision

Transcutaneous Electric Nerve Stimulation Clinical Trial

Official title:

The Effects of Two Different Electrical Stimulation Methods on the Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762486
• Other study ID #: YuksekIU
• Status: Completed
• Phase: N/A
• Start date: May 12, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: March 2018
• Source: Yuksek Ihtisas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of transcutaneous electrical nerve stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and analgesic drug consumption in patients who had undergone abdominal surgery with a midline incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and analgesic consumption on patients undergoing abdominal surgery with severe pain experience and high levels of neuroendocrine stress response is uncertain.

Description:

This research was conducted as a randomized controlled trial. 158 patients who had undergone abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for eligibility. This research sample consisted of 48 patients who underwent abdominal surgery with a midline incision. The patients were randomized into three groups, the first intervention group, which used TENS (around the incision), the second intervention group, which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and 45th hours after the operation. Pain scores and analgesic consumption were assessed in the first 48 hours after surgical intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who had an American Society of Anesthesiologists (ASA) score of I-II

• Patients were aged over 18 years

• Patients who could read and write Turkish

• Patients who were scheduled to undergo elective abdominal surgery with a midline incision for a diagnosis of stomach or colorectal cancer

• Patients without any impairment of vision, hearing or speech

Exclusion Criteria:

• Patients who had a pacemaker

• Patients whose skin integrity around the incision was degraded

• Patients had a cognitive disorder, had a history of chronic pain, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results

• Patients with an opioid addiction

• Patients those who had previously undergone electrical stimulation treatment

• Morbidly obese subjects

• Patients using psychoactive drugs

Related Conditions & MeSH terms

• Pain
• Transcutaneous Electric Nerve Stimulation

Intervention

Other:
• TENS
4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
• TAES
4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas University

References & Publications (34)

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Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. — View Citation

Chen L, Tang J, White PF, Sloninsky A, Wender RH, Naruse R, Kariger R. The effect of location of transcutaneous electrical nerve stimulation on postoperative opioid analgesic requirement: acupoint versus nonacupoint stimulation. Anesth Analg. 1998 Nov;87( — View Citation

Chen Y, Yang Y, Yao Y, Dai D, Qian B, Liu P. Does transcutaneous electric acupoint stimulation improve the quality of recovery after thyroidectomy? A prospective randomized controlled trial. Int J Clin Exp Med. 2015 Aug 15;8(8):13622-7. eCollection 2015. — View Citation

da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 201 — View Citation

DeSantana JM, Santana-Filho VJ, Guerra DR, Sluka KA, Gurgel RQ, da Silva WM Jr. Hypoalgesic effect of the transcutaneous electrical nerve stimulation following inguinal herniorrhaphy: a randomized, controlled trial. J Pain. 2008 Jul;9(7):623-9. doi: 10.10 — View Citation

Dias M, Carneiro NM, Guerra LA, Velarde GC, de Souza PA, da Silva LL, de Abreu e Souza RR, Nolasco R, Olej B. Effects of electroacupuncture on local anaesthesia for inguinal hernia repair: a randomised placebo-controlled trial. Acupunct Med. 2010 Jun;28(2 — View Citation

Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscop — View Citation

Feng X, Ye T, Wang Z, Chen X, Cong W, Chen Y, Chen P, Chen C, Shi B, Xie W. Transcutaneous acupoint electrical stimulation pain management after surgical abortion: A cohort study. Int J Surg. 2016 Jun;30:104-8. doi: 10.1016/j.ijsu.2016.04.042. Epub 2016 A — View Citation

Francis RP, Johnson MI. The characteristics of acupuncture-like transcutaneous electrical nerve stimulation (acupuncture-like TENS): a literature review. Acupunct Electrother Res. 2011;36(3-4):231-58. Review. — View Citation

Gavronsky S, Koeniger-Donohue R, Steller J, Hawkins JW. Postoperative pain: acupuncture versus percutaneous electrical nerve stimulation. Pain Manag Nurs. 2012 Sep;13(3):150-6. doi: 10.1016/j.pmn.2009.08.001. Epub 2010 Jan 6. — View 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. — View Citation

Hong SJ, Lee E. Effect of evidence-based postoperative pain guidelines via web for patients undergoing abdominal surgery in South Korea. Asian Nurs Res (Korean Soc Nurs Sci). 2014 Jun;8(2):135-42. doi: 10.1016/j.anr.2014.05.005. Epub 2014 May 21. — View Citation

Kara B, Baskurt F, Acar S, Karadibak D, Ciftci L, Erbayraktar S, Gokmen AN. The effect of TENS on pain, function, depression, and analgesic consumption in the early postoperative period with spinal surgery patients. Turk Neurosurg. 2011;21(4):618-24. doi: — View Citation

Kayman-Kose S, Arioz DT, Toktas H, Koken G, Kanat-Pektas M, Kose M, Yilmazer M. Transcutaneous electrical nerve stimulation (TENS) for pain control after vaginal delivery and cesarean section. J Matern Fetal Neonatal Med. 2014 Oct;27(15):1572-5. doi: 10.3 — View Citation

Kehlet H. Procedure-specific postoperative pain management. Anesthesiol Clin North America. 2005 Mar;23(1):203-10. Review. — View Citation

Kerai S, Saxena KN, Taneja B, Sehrawat L. Role of transcutaneous electrical nerve stimulation in post-operative analgesia. Indian J Anaesth. 2014 Jul;58(4):388-93. doi: 10.4103/0019-5049.138966. — View 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 201 — View Citation

Rakel B, Frantz R. Effectiveness of transcutaneous electrical nerve stimulation on postoperative pain with movement. J Pain. 2003 Oct;4(8):455-64. — View Citation

Robleda G, Roche-Campo F, Sánchez V, Gich I, Baños JE. Postoperative Discomfort After Abdominal Surgery: An Observational Study. J Perianesth Nurs. 2015 Aug;30(4):272-9. doi: 10.1016/j.jopan.2014.06.005. Epub 2015 May 16. — View Citation

Rosén HI, Bergh IH, Odén A, Mårtensson LB. Patients´ experiences of pain following day surgery - at 48 hours, seven days and three months. Open Nurs J. 2011;5:52-9. doi: 10.2174/1874434601105010052. Epub 2011 Jul 6. — View Citation

Sbruzzi G, Silveira SA, Silva DV, Coronel CC, Plentz RD. Transcutaneous electrical nerve stimulation after thoracic surgery: systematic review and meta-analysis of 11 randomized trials. Rev Bras Cir Cardiovasc. 2012 Jan-Mar;27(1):75-87. Review. English, P — View Citation

Senol Karatas S, Eti Z, Saraçoglu KT, Gögüs FY. Does perioperative opioid infusion increase postoperative opioid requirement? Agri. 2015;27(1):47-53. doi: 10.5505/agri.2015.71676. — View Citation

Silva MB, de Melo PR, de Oliveira NM, Crema E, Fernandes LF. Analgesic effect of transcutaneous electrical nerve stimulation after laparoscopic cholecystectomy. Am J Phys Med Rehabil. 2012 Aug;91(8):652-7. doi: 10.1097/PHM.0b013e318246638f. — View Citation

Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. Review. — View Citation

Tokuda M, Tabira K, Masuda T, Nishiwada T, Shomoto K. Effect of modulated-frequency and modulated-intensity transcutaneous electrical nerve stimulation after abdominal surgery: a randomized controlled trial. Clin J Pain. 2014 Jul;30(7):565-70. doi: 10.109 — View Citation

Unterrainer AF, Friedrich C, Krenn MH, Piotrowski WP, Golaszewski SM, Hitzl W. Postoperative and preincisional electrical nerve stimulation TENS reduce postoperative opioid requirement after major spinal surgery. J Neurosurg Anesthesiol. 2010 Jan;22(1):1- — View 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. — View Citation

Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a pr — View Citation

Ward CW. Procedure-specific postoperative pain management. Medsurg Nurs. 2014 Mar-Apr;23(2):107-10. — View Citation

Wu MS, Chen KH, Chen IF, Huang SK, Tzeng PC, Yeh ML, Lee FP, Lin JG, Chen C. The Efficacy of Acupuncture in Post-Operative Pain Management: A Systematic Review and Meta-Analysis. PLoS One. 2016 Mar 9;11(3):e0150367. doi: 10.1371/journal.pone.0150367. eCollection 2016. Review. — View Citation

Yeh ML, Chung YC, Chen KM, Chen HH. Pain reduction of acupoint electrical stimulation for patients with spinal surgery: a placebo-controlled study. Int J Nurs Stud. 2011 Jun;48(6):703-9. doi: 10.1016/j.ijnurstu.2010.10.009. Epub 2010 Nov 30. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain intensity	First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.; Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.; Control Group: No intervention was performed to the patients in the control group.; The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.	The pain levels were evaluated and compared within postoperative first 48 hours.
Secondary	Nausea severity	VAS with a range of 1-10 points was used while evaluating the nausea severity of all patients .The increase of the scale score shows that the nausea severity increases.	The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Secondary	Antiemetic drug consumption	The antiemetic drug amount administered to the patients was recorded in mg.	Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.
Secondary	Pulmonary function tests	The pulmonary functions of the patients were evaluated with a portable spirometer. Peak expiratory flow (PEF) and forced vital capacity (FVC) values were recorded. The measurement of respiratory functions was performed with the patient wrapping the disposable mouthpiece well with the lips during the measurement. The patient was asked to breathe deeply and exhale suddenly and quickly. This process was repeated three times and the best performance was taken as the base value.	Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.
Secondary	Vomiting	Vomiting: The number of times the patients vomited was recorded	Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Secondary	Analgesic drug consumption	All patients were administered intravenous tramadol hydrochloride infusion with the Patient Controlled Analgesia for the first 48 hours. Dexketoprofen trometamol vial intravenous and/or 50 mg. Pethidine hydrochloride intramuscular was used as the rescue analgesic.	Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.

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