Speed of Tenaculum Application for Procedural Pain

Overseen By Rebecca Allen, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Must not be taking: Narcotics, Opiates, Anti-anxiety, NSAIDs

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This project will be a randomized controlled trial (RCT) measuring pain perception with two different tenaculum placement techniques on the uterine cervix. A tenaculum is an instrument used to hold the cervix (the opening to the uterus or womb) in place. The trial will measure pain perception with a Visual Analog Scale (VAS) from 0 to 100 mm for two different tenaculum placement techniques, fast and slow closure on the uterine cervix. The main objective of this study is to determine if there is a difference in pain perception with fast compared to slow tenaculum placement techniques on the uterine cervix. We hypothesize that the slow technique will be perceived as less painful for subjects as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). Subsidiary objectives include describing overall pain levels during the procedure.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before participating. You cannot take any pain relievers, anti-anxiety medications, narcotics, or recreational drugs in the 24 hours before the trial.

What data supports the effectiveness of the treatment Speed of tenaculum application for reducing procedural pain?

Research shows that different techniques for tenaculum placement, such as 'slow' and 'cough', are used to manage pain, but no specific data directly compares the speed of application. However, studies indicate that local anesthetics can effectively reduce pain during tenaculum placement, suggesting that pain management strategies are important in these procedures. ^{1 2 3 4 5}

Is tenaculum application generally safe for humans?

Research indicates that tenaculum application, used in procedures like IUD insertion, is generally safe, though it may cause some pain and bleeding. Studies have explored different methods to reduce pain, such as using local anesthetics, but no significant safety concerns have been reported. ^{1 2 4 6 7}

How does the speed of tenaculum application treatment differ from other treatments for procedural pain?

This treatment is unique because it focuses on the speed of applying a tenaculum (a surgical instrument used to hold or grasp tissue) to potentially reduce pain during procedures, unlike other methods that typically use local anesthetics to manage pain. ^{1 2 4 8 9}

Research Team

Rebecca Allen, MD

Principal Investigator

Women & Infants Hospital

Eligibility Criteria

This trial is for women aged 18-49 planning to get an IUD or endometrial biopsy, who can consent and haven't used painkillers, anxiety meds, narcotics, or illegal drugs recently.

Inclusion Criteria

Plans for IUD insertion or endometrial biopsy

The ability and willingness to give informed consent

You are between 18 and 49 years old.

Exclusion Criteria

Do not speak English unless interpreter present

You have taken any strong pain medication in the last 24 hours.

Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tenaculum application using either fast or slow technique to measure pain perception

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Speed of tenaculum application

Trial Overview The study compares two ways of using a tenaculum during gynecological procedures: fast vs. slow application. It aims to see which method causes less pain as measured by a pain scale.

Participant Groups

Group I: Slow tenaculum application Experimental Treatment 1 Intervention

Group II: Fast tenaculum application Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Findings from Research

In a study of 74 women undergoing gynecologic procedures, those who received a 1% lidocaine intracervical injection reported significantly lower pain levels during tenaculum placement compared to those who received a 2% topical lidocaine gel (12.3 mm vs. 36.6 mm on a 100 mm scale).

Despite the lower pain during tenaculum placement with the injection, both groups reported similar satisfaction levels with the procedure, indicating that while the injection is more effective for pain management, it does not negatively impact overall satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial. Goldthwaite, LM., Baldwin, MK., Page, J., et al.[2014]

In a study of 118 patients, endometrial sampling without a tenaculum resulted in significantly lower pain perception compared to using a tenaculum, as measured by the Visual Analog Scale (VAS).

The use of a tenaculum was identified as an independent risk factor for increased pain during the procedure, suggesting that avoiding its use may enhance patient comfort during endometrial sampling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The necessity of using tenaculum for endometrial sampling procedure with pipelle: a randomized controlled study. Kucukgoz Gulec, U., Khatib, G., Guzel, AB., et al.[2019]

In a study involving 58 women undergoing hysterosalpingography, both lignocaine spray and lignocaine jelly were found to be equally effective in reducing pain during the application of a tenaculum to the cervix.

Pain scores measured by visual analogue scale and verbal descriptor scale showed no significant difference between the two forms of lignocaine, indicating that either can be used effectively for pain management in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomised, single-blinded, controlled trial comparing two topical anaesthetic modalities for the application of a tenaculum to the cervix. Costello, MF., Steigrad, S., Collet, A.[2013]

In a randomized controlled trial involving 66 women undergoing intrauterine device placement, neither the 'slow' nor 'cough' method of tenaculum placement significantly reduced pain, with median pain scores of 44 and 32 respectively (p=0.16).

Pre-procedure anxiety was found to significantly influence pain levels during tenaculum placement (p=0.01), suggesting that addressing anxiety may be important for improving patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. Lambert, T., Truong, T., Gray, B.[2020]

In a study with 10 healthy male volunteers, the use of EMLA cream significantly increased the time participants could tolerate tourniquet pain, allowing for an average of 46.4 minutes compared to 37.5 minutes with a placebo.

Pain scores were lower in the EMLA group at the 40-minute mark, indicating that EMLA effectively reduces pain perception associated with tourniquet use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a eutectic mixture of local anaesthetic agents (EMLA) on tourniquet pain in volunteers. Lowrie, A., Jones, MJ., Eastley, RJ.[2019]

The use of a suction cervical stabilizer during IUD insertion significantly reduced patient-reported pain compared to the standard single-tooth tenaculum, with pain scores lower by at least 14 points during key steps of the procedure.

The suction cervical stabilizer also demonstrated a better safety profile, with less mean blood loss compared to the control group, making it a promising alternative for IUD insertion, especially for nulliparous women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. Yaron, M., Legardeur, H., Barcellini, B., et al.[2023]

In a study involving 38 adult volunteers, the speed of lidocaine injection (slow vs. rapid) did not significantly affect the success or duration of pulp anesthesia after incisive/mental nerve blocks.

However, the slow injection method was found to be significantly more comfortable for patients compared to the rapid injection method, indicating a preference for patient comfort during dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of injection speed on the effectiveness of incisive/mental nerve block: a randomized, controlled, double-blind study in adult volunteers. Whitworth, JM., Kanaa, MD., Corbett, IP., et al.[2022]

In a study with 50 healthy participants, it was determined that the optimal stimulation frequency for eliciting the nociceptive flexion reflex (TS-NFR) is 2.0 Hz, using three stimuli per series, which helps standardize the measurement of spinal nociception.

The study found discrepancies between TS-NFR and subjective pain ratings (TS-pain), suggesting that relying on self-reported pain may not accurately reflect spinal nociceptive processes, highlighting the need for more objective measures in pain research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing procedures to study sensitization of human spinal nociceptive processes: comparing parameters for temporal summation of the nociceptive flexion reflex (TS-NFR). Terry, EL., France, CR., Bartley, EJ., et al.[2011]

In a study with 36 healthy volunteers, varying the speed of lidocaine injections (0.3 ml/s, 0.15 ml/s, and 0.1 ml/s) did not significantly affect the pain experienced during the injections, as measured by a visual analogue scale.

Participants showed no strong preference for any specific injection speed, indicating that the speed of local anaesthetic administration within this range does not impact pain levels during subcutaneous injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of injection speed on pain during injection of local anaesthetic. Tangen, LF., Lundbom, JS., Skarsvåg, TI., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

The necessity of using tenaculum for endometrial sampling procedure with pipelle: a randomized controlled study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A prospective, randomised, single-blinded, controlled trial comparing two topical anaesthetic modalities for the application of a tenaculum to the cervix. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effect of a eutectic mixture of local anaesthetic agents (EMLA) on tourniquet pain in volunteers. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Influence of injection speed on the effectiveness of incisive/mental nerve block: a randomized, controlled, double-blind study in adult volunteers. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Standardizing procedures to study sensitization of human spinal nociceptive processes: comparing parameters for temporal summation of the nociceptive flexion reflex (TS-NFR). [2011]

9. Sweden pubmed.ncbi.nlm.nih.gov

The influence of injection speed on pain during injection of local anaesthetic. [2016]