Clinical trial NCT02904915
Conditions: Analgesia IUD Insertion
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2017-01-12; Completion date: 2017-10-09
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Detailed description:

Arms: arm 1: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. arm 2: IUD placement with no analgesia.
Interventions: intervention 1: Lidocaine intervention 2: No analgesia intervention 3: Intrauterine device (IUD)
Intervention descriptions: intervention 1: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. intervention 2: IUD placement without analgesia. intervention 3: IUD placement with or without paracervical block with 1% lidocaine.

Protocol documents:
Prot_SAP_000.pdf: 
IRB NUMBER: HSC-MS-16-0664 
IRB APPROVAL DATE: 01/04/2017 
 
 
 
 
 
 
 
 
 
 
 
Paracervical block with IUD insertion versus no paracervical block IRB 
 
NCT02904915 
 
Version Date: 01/04/2017 
 
 


IRB NUMBER: HSC-MS-16-0664 
IRB APPROVAL DATE: 01/04/2017 
 
Paracervical block with IUD insertion versus no paracervical block IRB 
 
Protocol Title: 
Paracervical block versus no 
paracervical block during IUD insertion 
Principle Investigator: 
Pamela Berens 
Co-Investigators: 
Neda Jooya 
Population: 
50 Adults who present for IUD insertion 
at several UT Physicians Obstetrics and 
Gynecology clinics. 
Number of sites: 
Three: Dr. Patti Jayne Ross OB/GYN 
Continuity Clinic: UTPB Suite 350; UT 
Physicians Women’s Center- TMC: UTPB 
Suite 250; UT Physicians Women’s 
Center- Bellaire: 6700 West Loop South, 
Suite 450 
Study duration: 
October 2016 until completion 
(anticipated 1 year) 
Subject duration: 
20 minutes or less to place block and 
insert IUD 
 
 
 
 
 
General information 
 
We propose to compare paracervical block versus no local analgesia in women who 
present for IUD insertion. We will compare the patient’s procedural pain level with 
tenaculum placement and IUD insertion using paracervical block versus no 
analgesia during the IUD insertion procedure.. 
 
Background Information 
 
In the United States, approximately 7% of women used intrauterine devices (IUD) for 
contraception in 2012 (Guttamacher institute). To date, no standard method of pain 
control with IUD insertion has been proposed or adopted. IUDs have a less than 
1% rate of failure depending on the type of IUD used and have a high rate of 
compliance. Some barriers to women obtaining the IUD are: cost and the perceived 
pain associate with IUD insertion including stimulation of cervical parasympathetic 


IRB NUMBER: HSC-MS-16-0664 
IRB APPROVAL DATE: 01/04/2017 
 
and sympathetic nerve fibers and prostaglandin release. Some research has been 
done on the difference in pain experienced with IUD insertion using paracervical 
block with conflicting results (Mody, Cirik). In a study of nulliparous women, 2% 
topical lidocaine gel has been found to be effective for pain relief at the tenaculum 
site however it’s use in a clinical setting is uncommon (Rapkin, et al). This study 
involved self-administration of the topical product prior to the procedure and may 
be distasteful to some patients. Despite the controversy regarding the effectiveness 
of various techniques for pain management, a recent revision of the U.S. Select 
Practice Recommendations for Contraception (2016) includes a recommendation 
that “paracervical block with lidocaine might reduce patient pain during IUD 
insertion.” 
 
We are interested in performing an open label randomized controlled trial of local 
block versus no local block in a group of women who present to the Dr. Patti Jayne 
Ross OB/GYN Continuity Clinic, the UT Physicians Women’s Center, and the UT 
Physicians Women’s Center- Bellaire for IUD insertion. Individual providers vary in 
their use of a local block for pain with IUD procedures. We will collect data on the 
vital signs of each woman undergoing an IUD insertion procedure. We also plan on 
collecting demographic information on each patient involved in the study. We plan 
on assessing the pain of each individual throughout each individual IUD insertion 
procedure using a visual analogue pain scale. Each patient will be randomized to 
receive either a paracervical block or no local analgesia. A standard protocol for 
administration of paracervical block will be delineated, distributed, and used for the 
study. Patient pain will be assessed prior to, during the placement of tenaculum, and 
after the procedure using the visual analogue scale tool. 
 
The study will take place at the clinics mentioned above. IUD placement will be 
carried out by residents and faculty at the Memorial Hermann and LBJ Hospital 
Obstetrics and Gynecology residency programs rotating through the 
aforementioned clinics. 
 
Objectives 
 
We would like to compare patient pain perception in IUD insertion when using 
paracervical block versus no block. We aim to improve pain in this patient 
population. 
 
Study Design 
 
The study will be an open label randomized controlled trial. Each woman will be 
consented to the study and either randomized to receive paracervical block or 
routine care (no local analgesia). The level of pain of each woman will be assessed 
before the procedure but after placement of the speculum, during placement of the 
tenaculum, and after the procedure by using a visual analogue pain assessment 
scale. Vital signs will also be taken prior to and after completion of the procedure. 
 
Each patient will be consented prior to the study. 


IRB NUMBER: HSC-MS-16-0664 
IRB APPROVAL DATE: 01/04/2017 
 
We would like to assess the following in each of the study participants undergoing 
the IUD insertion procedure.  
 
a) Age, race, gravity, and parity  
 
b) Type of IUD received 
 
c) Randomization status, i.e. whether each participant received a paracervical block 
or not  
 
d) History of vaginal, pelvic, or cervical surgery  
 
e) History of sexually transmitted infection or pelvic inflammatory disease 
 
f) Vital signs (including but not limited to blood pressure, respiratory rate, pulse, 
and oxygen saturation) before and after the procedure  
 
g) Patient rating of pain before, during tenaculum placement, and after the 
procedure.  
 
h) Complications associated with IUD insertion procedure or block itself (i.e.: 
cervical stenosis requiring dilation, failure of IUD placement, bleeding) 
 
i) Other pain medications taken by the patient on the day of but prior to the 
procedure 
 
Study Population 
 
Women of reproductive age, having IUD placed at the Dr. Patti Jayne Ross OB/GYN 
continuity clinic, The UT Physicians Women’s Center, and the UT Physicians 
Women’s Center- Bellaire during the study time. 
 
Inclusion criteria: 
 
Women of reproductive age between ages 18 and 52 who present for an IUD 
insertion procedure. 
 
Exclusion criteria:   Women less than age 18 and greater than age 52, women with 
current PID, women who are not good candidates for an IUD, and patients who have 
a Lidocaine allergy. 
 
Women aged 18 and over will undergo a consent process prior to being enrolled in 
the study. 
 
Study Procedures 
 
Women who meet inclusion criteria who present to the abovementioned locations 
will be informed of the study, and those agreeing will be asked to sign a consent. 


IRB NUMBER: HSC-MS-16-0664 
IRB APPROVAL DATE: 01/04/2017 
 
These patients will be informed that routine care for our practice is no analgesia. 
These women will then be randomized to either a group getting no analgesia during 
the IUD insertion procedure and those receiving a paracervical block with 1% 
Lidocaine prior to the procedure. An established protocol will be used for the 
paracervical block arm of the study. Patient vitals will be assessed 5 minutes prior 
to procedure and 5 minutes after procedure. Patient pain scale will be assessed after 
speculum placement but prior to any procedure, with tenaculum placement and 
after placement of the IUD. All complications associated with the IUD insertion 
procedure will also be analyzed as will failure to successfully insert the IUD. 
 
The following paracervical block protocol will be used for this study: 
Paracervical block protocol (Study arm) 
Tools: 
Speculum 
10 cc syringe 
1% Lidocaine 
Single tooth tenaculum 
 
 
 
1.   Obtain consent and randomization 
2.   Perform pre-procedure vital signs 
3.   Insert the speculum into the vagina 
4.   Perform pain scale #1 
5.   Identify the cervix 
6.   Apply Betadine to the cervix and surrounding vaginal tissue 
7.   Insert the syringe into the cervico-vaginal junction at 12 o’clock (the 
anticipated tenaculum site). Inject 2 cc of Lidocaine at the tenaculum site on 
the cervix, making sure to first draw back on the plunger to ensure that the 
needle is not inserted into a blood vessel. 
8.   Place tenaculum at the anterior lip of the cervix at 12 o’clock 
9.   Perform pain scale #2 
10. Inject 3 cc of 1% lidocaine and 4 and 8 o’clock position of the cervix. Ensure 
that you insert the syringe into the cervix at the cervico-vaginal junction and 
withdraw the plunger to ensure the needle is not inserted into a blood vessel 
prior to injecting. 
11. Wait 3 minutes after last injection before starting IUD insertion procedure 
12. Insert IUD 
13. Perform pain scale #3 
14. Cut IUD strings and remove all instruments from the vagina 
15. Perform post procedure vital signs 
 
Paracervical block protocol (Control Arm) 
Tools: 


IRB NUMBER: HSC-MS-16-0664 
IRB APPROVAL DATE: 01/04/2017 
 
Speculum 
Single tooth tenaculum 
 
1.   Obtain consent and randomization 
2.   Perform pre-procedure vital signs 
3.   Insert the speculum into the vagina 
4.   Perform pain scale #1 
5.   Identify the cervix 
6.   Apply Betadine to cervix and surrounding vaginal tissue 
7.   Place tenaculum at the anterior lip of the cervix at 12 o’clock 
8.   Perform pain scale #2 
9.   Insert IUD 
10. Perform pain scale #3 
11. Cut IUD strings and remove all instruments from the vagina 
12. Perform post procedure vital signs 
 
 
 
Statistics 
 
Demographic characteristics will be assessed and described using descriptive 
variables. Vital sign assessment and pain scale assessment will be described using 
numerical categories. A two tail T-Test will be used to assess the data and we will 
look for a 20% difference in the pain score. 
 
Ethics 
 
IRB approval will be sought with the University of Texas system.  
 
Informed consent in writing will be obtained in English from each individual prior 
to enrollment. No coercion will be used. Recruitment and consent will be obtained 
by Dr. Jooya and a group of previously authorized and trained residents and 
attendings working out of the clinic. 
 
Data handling and record keeping 
 
Participant information will be stored on encrypted computers owned by Drs. 
Berens and Jooya. 
 
Quality control and assurance 
 
All data collection will be taken by previously authorized members of the 
aforementioned residency programs. 
 
Publication plan 
 
Results are planned for publication. Participants will not be notified of results. 


IRB NUMBER: HSC-MS-16-0664 
IRB APPROVAL DATE: 01/04/2017 
 
Sources: 
 
Mody et al. Pain control for intrauterine device insertion: a randomized trial of 1% 
lidocaine paracervical block. Contraception 86 (2012) 704-709. 
 
Cirik et al. Paracervical block with 1% lidocaine for pain control during intrauterine 
device insertion: a prospective, single-blinded, controlled study. International 
Journal of Reproduction, Contraception, Obstetrics and Gynecology. 2013 
Sep;2(3);263-267 
 
 
Rapkin RB, Achilles SL, Schwarz EB, et al. Self-Administered Lidocaine Gel for 
Intrauterine Device Insertion in Nulliparous women: A Randomized Controlled Trial. 
Obstet Gynecol. 2016 Sep;128(3):621-8. 
 
Lopez LM, Bernholc A, Zeng Y, Allen RH, et al. Interventions for pain with 
intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 
29;(7):CD007373. Review 
 
US. Selected Practice Recommendations for Contraceptive Use, 2016 MMWR July 
2016/65(4);1-66. 
 
Hepburn. Method of Local Anesthesia for IUD Insertion. Contraceptive Delivery 
Systems. 1980, 371-377.