An interventional study of 1% Lidocaine with adrenaline and 1% Lidocaine in Ecchymosis, Adverse Anesthesia Outcome and Complications Associated With Device, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Supportive care
This randomized, double-blinded controlled trial evaluates whether lidocaine with adrenaline reduces bruising (ecchymosis) more effectively than lidocaine without adrenaline among women undergoing contraceptive implant insertion or removal at King Chulalongkorn Memorial Hospital. Bruising is common after these procedures and may contribute to stigma and concealment behaviors; adrenaline's vasoconstrictive effect may lessen bleeding, prolong anesthesia, and reduce bruising, but the two formulations have not been directly compared in this setting.
A total of 450 women aged ≥18 years will be enrolled and randomized 1:1 (sealed opaque envelopes) to receive either lidocaine with adrenaline or lidocaine without adrenaline during implant insertion or removal. Participants and outcome assessors will be blinded. During the procedure, blood loss, heart rate, blood pressure, and pain will be recorded. Post-procedure follow-up lasts 7 days: participants submit standardized photos of the procedure site via Line OA on Day 3 and Day 7 for bruise assessment and report pain onset and satisfaction with wound appearance/healing.
Risks include transient effects potentially related to adrenaline (e.g., restlessness, palpitations, flushing, dizziness, brief increases in heart rate or blood pressure) and typical minor procedure-related effects (pain, mild bleeding, temporary discomfort). Vital signs will be monitored before and up to 30 minutes after anesthetic administration. Photo submission carries minimal privacy risk; images and data will be coded and stored securely with access limited to authorized personnel. If an adverse event is related to study participation and instructions were followed, medical costs and reasonable loss-of-time compensation will be covered. No insurance is provided.
No direct benefit to participants is expected, but findings may improve clinical practice by reducing bruising and enhancing patient satisfaction with contraceptive implant services. Participation is voluntary; withdrawal is permitted at any time without affecting medical care. Collected data will be anonymized; investigators, the sponsor, and authorized ethics/regulatory bodies may review records as permitted by law. Data will be destroyed after study completion; no biological samples will be stored.
Principal investigator contact: Assoc. Prof. Somsook Santibenchakul, MD, PhD, MPH, Department of Obstetrics and Gynecology, King Chulalongkorn Memorial Hospital, 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand; dr.somsook@gmail.com
Background and rationale Ecchymosis at the insertion or removal site is a recognized local reaction to subdermal contraceptive implant procedures. At King Chulalongkorn Memorial Hospital, the introduction of telemedicine follow-up, in which clients submit photographs of the procedure site after the visit, revealed a higher-than-expected frequency of visible bruising. Although clinically minor, bruising is conspicuous on lighter skin, and in the Thai context, where stigma surrounds sexual and reproductive health services, visible bruising may lead women to conceal the procedure site with makeup or long-sleeved clothing.
The standard local anesthetic for implant procedures at the study site is 1% lidocaine without adrenaline, selected partly because it does not require refrigerated storage. Adrenaline added to lidocaine produces local vasoconstriction, which has been reported to reduce operative bleeding, prolong subcutaneous anesthesia in a dose-related manner, and limit systemic absorption of the anesthetic. Evidence on whether these effects reduce post-procedural ecchymosis is inconsistent: reduced bleeding or hematoma has been reported in incisional surgery and great saphenous vein stripping, whereas trials in rhinoplasty and hyaluronic acid filler injection found no significant reduction in ecchymosis. No trial has directly compared lidocaine with and without adrenaline for contraceptive implant insertion or removal. The study hypothesis is that lidocaine with adrenaline reduces the incidence and severity of ecchymosis, with a comparable profile of adrenaline-related adverse effects.
Interventions The intervention arm receives 1% lidocaine with epinephrine 1:100,000; the comparator arm receives 1% lidocaine without epinephrine. The anesthetic is infiltrated at the procedure site immediately before implant insertion or removal using standard technique, including aspiration before injection to avoid intravascular administration. The total volume administered (mL) and the procedure type (insertion, removal, or replacement) are recorded. All other aspects of the procedure follow routine clinical practice at the Family Planning Clinic.
Recruitment, consent, and allocation Clients attending the Family Planning Clinic for implant procedures are informed of the study through posters in the clinic. A trained research assistant who is not involved in the participant's clinical care provides study information and obtains written informed consent in a private area before the procedure. Eligible participants are allocated 1:1 to the two arms using sealed, opaque, sequentially numbered envelopes. The anesthetic is prepared by a single designated research assistant who has no role in recruitment, informed consent, performing procedures, or outcome assessment. Both formulations are clear, colorless solutions; each dose is drawn into an identical unlabeled syringe, which is sealed in an opaque envelope marked only with the participant's study identification number, so that the formulation cannot be distinguished by the clinician performing the procedure.
Follow-up and photographic assessment Post-procedure communication is conducted through the clinic's LINE Official Account (LINE OA), with reminder messages to support retention. Participants receive a standardized transparent ruler sticker and written instructions for photographing the procedure site: well-lit conditions without shadows, the camera held at least 30 cm from the site and within 20 degrees of perpendicular, the ruler sticker and at least 3 inches of surrounding skin included in the frame, and three photographs taken from slightly different angles. On Day 3, participants photograph the adhesive dressing pad so that residual blood staining can be measured, using the pad dimensions as a size reference.
Two independent examiners, blinded to allocation, assess ecchymosis from the submitted photographs. Before the study, the examiners complete joint training using 10 image sets from a previous telemedicine follow-up cohort at the study site; inter-rater reliability is then evaluated on 10 additional image sets using the intraclass correlation coefficient. During the study, each examiner independently measures the area and records the color of any ecchymosis. When the two area measurements differ by less than 10%, the mean is used; when the difference is 10% or greater, the examiners re-assess the image jointly to reach consensus. Severity is graded according to the area-based categories described under Outcome Measures.
Safety monitoring Pulse rate and blood pressure are measured at clinic admission and after the procedure, and participants are observed for symptoms attributable to adrenaline (e.g., nervousness, tremor, palpitations, flushing, light-headedness). Adverse events reported in the clinic or through LINE OA are documented and managed according to standard clinical care.
Sample size The sample size was calculated for a comparison of two independent proportions (two-sided alpha 0.05, power 80%, 1:1 allocation), assuming an incidence of any ecchymosis of 49.2% with lidocaine alone and 34.4% with lidocaine plus adrenaline (a 30% relative reduction), based on data from the institution's previous telemedicine follow-up study. After inflation by 30% for loss to follow-up, the target is 225 participants per arm (450 in total).
Statistical analysis The proportion of participants with any ecchymosis is compared between arms using the Pearson chi-square test (or Fisher's exact test when expected counts are small), with the relative risk and 95% confidence interval; regression models are used to adjust for potential confounders such as age and parity. Ordinal outcomes are analyzed with ordinal logistic regression and Fisher's exact test, with Bonferroni-corrected pairwise comparisons where indicated. Continuous outcomes are compared using the independent t-test or the Mann-Whitney U test according to distribution, and within-group changes in vital signs using the paired t-test or the Wilcoxon signed-rank test. Time to first analgesic use is compared using the log-rank test. Statistical significance is set at a two-sided p \< 0.05.
Data management Data and photographs are labeled with study identification numbers rather than personal identifiers, stored securely, and accessible only to authorized study personnel. No biological specimens are collected or stored.
38 studies on the registry are indexed under Ecchymosis; 6 are open to participants now.
This study's enrollment of 450 is above the median of 66 across 34 interventional studies indexed under Ecchymosis.
Browse Ecchymosis studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug name: Lidocaine 1% with adrenaline (epinephrine) Concentration: 1% lidocaine (10 mg/mL) with adrenaline 1:100,000 (equivalent to 0.01 mg/mL) Dosage and administration: Upto 10 mL of solution will be used as local anesthesia at the implant insertion or removal site. Route: Subdermal / local infiltration Purpose: To provide local anesthesia and to assess its effect on post-procedural bruising compared with lidocaine 1% without adrenaline.
Drug: 1% Lidocaine with adrenaline
Drug name: Lidocaine 1% (without adrenaline) Concentration: 1% lidocaine (10 mg/mL) Dosage and administration: Upto 10 mL of solution will be used as local anesthesia at the implant insertion or removal site. Route: Subdermal / local infiltration Purpose: To provide local anesthesia and serve as the comparator for assessing the effect of adrenaline addition on post-procedural bruising.
Drug: 1% Lidocaine
Drug pages: Lidocaine · Epinephrine
1% Lidocaine with adrenaline upto 10 ml
1% Lidocaine upto 10 ml
Incidence and severity of ecchymosis assessed from standardized digital photographs
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.
Time frame: Day 7 after contraceptive implant insertion or removal
Pain intensity assessed using the Numeric Rating Scale (NRS)
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.
Time frame: 15 minutes and 60 minutes after the procedure
Duration of anesthesia, measured as time to first postoperative analgesic use
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.
Time frame: From the end of the procedure up to 24 hours after the procedure
Number of participants with bleeding at the procedure site
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.
Time frame: From the procedure through Day 7 after the procedure
Change in pulse rate from baseline
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.
Time frame: Baseline (on arrival at the clinic) and 15 minutes after the procedure
Number of participants with adrenaline-related symptoms
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.
Time frame: 15 minutes and 30 minutes after the procedure
Intra-procedural bleeding rated by the clinician using a 3-point scale
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.
Time frame: During the procedure
Area of residual bleeding on the dressing pad
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.
Time frame: Day 3 after procedure
Participants' self-reported ecchymosis severity
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.
Time frame: Day 7 post-procedure
Participant satisfaction assessed using a 5-point Customer Satisfaction (CSAT) scale
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.
Time frame: Day 7 after procedure
Change in systolic and diastolic blood pressure from baseline
Change in systolic and diastolic blood pressure, each in millimeters of mercury (mmHg), calculated as the value measured 15 minutes after the procedure minus the baseline value measured on arrival at the clinic. Systolic and diastolic values are reported separately. Positive values indicate an increase from baseline.
Time frame: Baseline (on arrival at the clinic) and 15 minutes after the procedure
Plan to share: Yes — All individual participant data (IPD) underlying the results reported in the publication will be made available upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The individual participant data (IPD) and supporting information will be available upon completion of the study and publication of the results.
Access criteria: De-identified individual participant data (IPD) and supporting study documents, including the study protocol and statistical analysis plan, will be available upon reasonable request to qualified researchers whose proposed use of the data has been approved by the principal investigator. Requests should be submitted in writing with a brief research proposal and data access agreement. Approved data will be shared through secure, password-protected electronic transfer.
Data sharing details ↗ · www.chulafamilyplanning.com
Ran from Jan 2026 to primary completion in Mar 2026, 2 months.
Of 14 interventional studies with no phase under Ecchymosis, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Epinephrine