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

NCT03762486 | Completed DMC

• 1 other identifier: YuksekIU
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Transcutaneous Electric Nerve Stimulation

Keywords

Postoperative pain; Alternative therapy; Acupuncture; TENS; Surgical nursing; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Nausea severity

  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.

• Antiemetic drug consumption

  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.

• Pulmonary function tests

  Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.

• Vomiting

  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.

• Analgesic drug consumption

  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.

Study Arms (3)

TENS to around the incision

ACTIVE COMPARATOR

The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.

Other: TENS

TAES to the acupuncture points

ACTIVE COMPARATOR

The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.

Other: TAES

No stimulation

NO INTERVENTION

No stimulation was performed to the patients in the control group.

Interventions

TENS OTHER

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

Also known as: First Intervention Group

TENS to around the incision

TAES OTHER

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

Also known as: Second Intervention Group

TAES to the acupuncture points

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Related Publications (34)

• 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. doi: 10.1016/s0883-5403(03)00458-3.

  PMID: 14716650 BACKGROUND

• 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.

  PMID: 26959661 BACKGROUND

• 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):65-70. doi: 10.1136/aim.2009.000570.

  PMID: 20615859 RESULT

• Bjersa K, Andersson T. High frequency TENS as a complement for pain relief in postoperative transition from epidural to general analgesia after pancreatic resection. Complement Ther Clin Pract. 2014 Feb;20(1):5-10. doi: 10.1016/j.ctcp.2013.11.004. Epub 2013 Nov 20.

  PMID: 24439637 RESULT

• Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.

  PMID: 12600800 RESULT

• 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(5):1129-34.

  PMID: 9806695 RESULT

• 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.

  PMID: 26550304 RESULT

• 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 2015 Feb 10.

  PMID: 25665520 RESULT

• 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: 10.1016/j.jpain.2008.01.337. Epub 2008 Apr 3.

  PMID: 18387854 RESULT

• 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 thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.

  PMID: 25935320 RESULT

• 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.

  PMID: 22531569 RESULT

• 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 Apr 29.

  PMID: 27142864 RESULT

• 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 prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.

  PMID: 24576720 RESULT

• 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.

  PMID: 25030646 RESULT

• 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.

  PMID: 22194125 RESULT

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

  PMID: 25867874 RESULT

• 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: 10.3109/14767058.2013.870549. Epub 2014 Jan 8.

  PMID: 24283391 RESULT

• Kehlet H. Procedure-specific postoperative pain management. Anesthesiol Clin North Am. 2005 Mar;23(1):203-10. doi: 10.1016/j.atc.2004.11.001.

  PMID: 15763419 RESULT

• 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.

  PMID: 25197104 RESULT

• 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.

  PMID: 10551571 RESULT

• Rakel B, Frantz R. Effectiveness of transcutaneous electrical nerve stimulation on postoperative pain with movement. J Pain. 2003 Oct;4(8):455-64. doi: 10.1067/s1526-5900(03)00780-6.

  PMID: 14622666 RESULT

• 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. doi: 10.3727/036012911803634139.

  PMID: 22443026 RESULT

• Robleda G, Roche-Campo F, Sanchez V, Gich I, Banos 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.

  PMID: 26210558 RESULT

• Rosen HI, Bergh IH, Oden A, Martensson 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.

  PMID: 21769308 RESULT

• 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. doi: 10.5935/1678-9741.20120012. English, Portuguese.

  PMID: 22729304 RESULT

• 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.

  PMID: 22311059 RESULT

• Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.

  PMID: 14622708 RESULT

• 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.

  PMID: 22929602 RESULT

• 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: 10.1097/AJP.0b013e31829ea151.

  PMID: 24901753 RESULT

• 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):1-5. doi: 10.1097/ANA.0b013e3181b7fef5.

  PMID: 19779370 RESULT

• 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.

  PMID: 9249122 RESULT

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

  PMID: 24933788 RESULT

• Yeh ML, Chung YC, Chen KM, Tsou MY, Chen HH. Acupoint electrical stimulation reduces acute postoperative pain in surgical patients with patient-controlled analgesia: a randomized controlled study. Altern Ther Health Med. 2010 Nov-Dec;16(6):10-8.

  PMID: 21280458 RESULT

• 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.

  PMID: 21122849 RESULT

Related Links

• for access to resources

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Emine Iyigun, Professor

  Turkish Nurses Society

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Staff

Model Details: TENS was applied to around the insicion: Transcutaneous electrical nerve stimulation was applied to around the incision. TAES was applied to acupuncture points: Transcutaneous electrical stimulation was applied to acupuncture points. No intervention: No stimulation was performed to the patients. A standard analgesia protocol for post-operative pain control was used in all patients included in the study. A standard antiemetic protocol was used for all patients after surgery.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: December 3, 2018
• Study Start: May 12, 2015
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: December 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share