Transcutaneous Electrical Nerve Stimulation During Transvaginal Oocyte Retrieval

Transcutaneous Electric Nerve Stimulation Clinical Trial

Official title:

Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Relief During Transvaginal Oocyte Retrieval Using Conscious Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472430
• Other study ID #: TENS TUGOR ver 1
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: October 15, 2018

Study information

• Verified date: February 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized double-blinded control trial aims to compare the pain levels experienced by the women using the standard conscious sedation and those who had transcutaneous electrical nerve stimulation (TENS) in addition to conscious sedation. The hypothesis is that there will be less pain in women with both conscious sedation and TENS.

Description:

Women who are indicated to undergo IVF in our center will be assessed for eligibility for the study. Written consent will be obtained from those who agreed to join the study.

Eligible women recruited will be randomized according to a computer-generated randomization list prepared by a designated research staff into one of the two groups on the day of oocyte retrieval

1. Patient with both conscious sedation and active TENS

2. Patient with conscious sedation and placebo TENS

Blinding Both the women and the physician performing the procedure will be blinded from the group allocation.

Checking of effectiveness of blinding will be done by asking the patient and the physician after the procedure as to which group they think the women is in.

The procedure Women will receive ovarian stimulation according to the departmental Standard Operating Procedures. Ovarian stimulation will be monitored by ultrasound. Human chorionic gonadotrophin or an agonist (decapeptyl) will be given when the dominant follicle is at least 18mm and there are three more follicles of at least 16mm. Oocyte retrieval will then be arranged 36 hours later.

Prior to oocyte retrieval, two sets of self-adhesive electrodes will be placed on the women back on each side of the spine at T10 to S4 level. Instructions on how to titrate the TENS amplitude to the desired level that gives a strong non-painful electrical paraesthesia will be given to the women by the research nurse who is unaware of the group allocation. TENS therapy will start 5 minutes before the procedure and stop 5 minutes after the removal of oocyte aspiration needle. The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses s−. The women in the treatment group will be given a TENS machine with electrodes emitting impulses while those in the placebo group will be given a TENS machine with electrodes that is not emitting any impulses.

The woman lies on the operative bed in a lithotomy position. 25mg Pethidine and 5mg Diazepam will be given intravenously. The blood pressure and pulse of the woman are checked after the drug administration and the oxygen saturation is monitored continuously throughout the procedure. 10ml 1% lignocaine is injected to the paracervical region by the operating surgeon with a 21-gauge needle after cleansing the vagina and cervix with chlorhexidine. Under transvaginal ultrasound guidance, a 16-gauge ovum aspiration needle is introduced. Aspiration of follicles is performed with a suction pressure of 100 mmHg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 15, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Women who undergo transvaginal oocyte retrieval

Exclusion Criteria:

• There is only one ovary

• Oocyte retrieval performed on one ovary only

• There are less than three follicles >=16mm in diameter

• Allergic to pethidine or midazolam

• Previous experience with TENS

• Skin damage or allergy at site of TENS pads application

• History of pacemaker insertion

Related Conditions & MeSH terms

• Oocyte Retrieval
• Transcutaneous Electric Nerve Stimulation

Intervention

Device:
• Transcutaneous electrical nerve stimulation
The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses.
• TENS machine with electrodes not emitting any impulses.
TENS machine with electrodes not emitting any impulses.

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynaecology	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (8)

Johnson M. Watson T. Transcutaneous electrical nerve stimulation, Electrotherapy: Evidence-based Practice. , 2008 Edinburgh Churchill Livingstone (pg. 253 -96)

Kwan I, Bhattacharya S, Knox F, McNeil A. Pain relief for women undergoing oocyte retrieval for assisted reproduction. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD004829. doi: 10.1002/14651858.CD004829.pub3. Review. Update in: Cochrane Database Syst Rev. 2018 May 15;5:CD004829. — View Citation

Lier MC, Douwenga WM, Yilmaz F, Schats R, Hompes PG, Boer C, Mijatovic V. Patient-Controlled Remifentanil Analgesia as Alternative for Pethidine with Midazolam During Oocyte Retrieval in IVF/ICSI Procedures: A Randomized Controlled Trial. Pain Pract. 2015 Jun;15(5):487-95. doi: 10.1111/papr.12189. Epub 2014 Apr 12. — View Citation

Lisón JF, Amer-Cuenca JJ, Piquer-Martí S, Benavent-Caballer V, Biviá-Roig G, Marín-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842. — View Citation

Ng EH, Chui DK, Tang OS, Ho PC. Paracervical block with and without conscious sedation: a comparison of the pain levels during egg collection and the postoperative side effects. Fertil Steril. 2001 Apr;75(4):711-7. — View Citation

Ng EH, Tang OS, Chui DK, Ho PC. A prospective, randomized, double-blind and placebo-controlled study to assess the efficacy of paracervical block in the pain relief during egg collection in IVF. Hum Reprod. 1999 Nov;14(11):2783-7. — View Citation

Ng EH, Tang OS, Chui DK, Ho PC. Comparison of two different doses of lignocaine used in paracervical block during oocyte collection in an IVF programme. Hum Reprod. 2000 Oct;15(10):2148-51. — View Citation

Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	The women will be asked to rate the pain according to a 100mm linear visual analogue scale. The visual analogue scale range from 0 to 100, 0 indicating no pain and 100 indicating maximum pain. A small value in the visual analogue scale indicates lower pain levels, therefore better. It is a single level indicated by the patients.	1 day on the day of the retrieval procedure
Secondary	Side effects	Side effects experienced by the women	1 day on the day of the retrieval procedure
Secondary	Women satisfaction	Patient's satisfaction towards pain relief will be assessed before discharge. They will be rated as 5, 'excellent'; 4, 'satisfactory'; 3, 'fair'; 2,'not very satisfactory' and 1, 'totally unsatisfactory.	1 day on the day of the retrieval procedure