Trial · NCT07897201
Comparison of Lidocaine With and Without Adrenaline for Reducing Ecchymosis
NCT07897201, Not applicable, Completed, Chulalongkorn University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Lidocaine With and Without Adrenaline for Reducing Ecchymosis. Trials, record NCT07897201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897201
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Lidocaine With and Without Adrenaline for Reducing Ecchymosis
- NCT number
- NCT07897201
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 450 participants, actual
- Lead sponsor
- Chulalongkorn University
- Conditions
- Ecchymosis, Adverse Anesthesia Outcome, Complications Associated With Device, Bleeding
- Interventions
- 1% Lidocaine with adrenaline, 1% Lidocaine
- First posted
- 2026-10-27
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of ecchymosis assessed from standardized digital photographs | Day 7 after contraceptive implant insertion or removal | Number of participants in each ecchymosis severity grade at the implant insertion or removal site, assessed by two independent outcome assessors blinded to allocation using standardized digital photographs that include a transparent ruler sticker for scale. Severity is graded by the measured area of discoloration: None (no visible ecchymosis), Mild (less than 1 cm²), Moderate (1 to 3 cm²), or Severe (more than 3 cm²). Higher grades indicate worse bruising. Incidence of ecchymosis is defined as any grade other than None. When the two assessors' area measurements differ by 10% or more, a consensus measurement is used. |
| Secondary | Pain intensity assessed using the Numeric Rating Scale (NRS) | 15 minutes and 60 minutes after the procedure | Participant-reported pain at the procedure site measured with the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
| Secondary | Duration of anesthesia, measured as time to first postoperative analgesic use | From the end of the procedure up to 24 hours after the procedure | Time in minutes from the end of the procedure to the first use of any pain-relief medication, as reported by the participant through the hospital's LINE Official Account on the evening of the procedure day. Longer times indicate longer-lasting anesthesia. Participants who do not use any pain-relief medication are censored at 24 hours. |
| Secondary | Number of participants with bleeding at the procedure site | From the procedure through Day 7 after the procedure | Number of participants with any bleeding at the implant insertion or removal site after the procedure, either reported by the participant through the hospital's LINE Official Account or identified by the study team on submitted photographs of the procedure site. Bleeding is defined as visible fresh blood or blood oozing from the procedure site after the participant leaves the clinic. |
| Secondary | Change in pulse rate from baseline | Baseline (on arrival at the clinic) and 15 minutes after the procedure | Change in pulse rate, in beats per minute, calculated as the pulse rate measured 15 minutes after the procedure minus the baseline pulse rate measured on arrival at the clinic. Positive values indicate an increase from baseline. |
| Secondary | Number of participants with adrenaline-related symptoms | 15 minutes and 30 minutes after the procedure | Number of participants reporting one or more symptoms potentially related to adrenaline, assessed by direct questioning: nervousness, anxiety, tremor or shakiness, flushing, sweating, light-headedness, tingling, or a sensation of a racing heart. |
| Secondary | Intra-procedural bleeding rated by the clinician using a 3-point scale | During the procedure | Bleeding during the procedure rated by the clinician performing the procedure on a 3-point scale based on visual estimation of blood loss and the need for any intervention to control bleeding: 1 = minimal, 2 = mild to moderate, 3 = moderate to severe. Scores range from 1 to 3; higher scores indicate more bleeding. |
| Secondary | Area of residual bleeding on the dressing pad | Day 3 after procedure | Area of blood staining on the adhesive dressing pad (transparent film dressing with absorbent pad), in square centimeters (cm²), measured from a photograph submitted by the participant through the hospital's LINE Official Account, using the known dimensions of the pad as a size reference. Larger areas indicate more post-procedure bleeding. |
| Secondary | Participants' self-reported ecchymosis severity | Day 7 post-procedure | Number of participants in each self-rated bruising severity category, based on perceived discoloration, pain, and appearance of the procedure site: None (no visible ecchymosis), Mild (slight discoloration or minimal pain), Moderate (noticeable discoloration and/or moderate discomfort), or Severe (significant discoloration and/or severe discomfort). Higher categories indicate worse bruising. |
| Secondary | Participant satisfaction assessed using a 5-point Customer Satisfaction (CSAT) scale | Day 7 after procedure | Satisfaction with the procedure, including the appearance and healing of the procedure site, measured with the Customer Satisfaction Score (CSAT), a single 5-point rating ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37525129 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07897201
GET https://conductscience.org/api/trials/v1/NCT07897201/registered