Primary Health Condition(s) or Problem(s) Studied: The primary clinical focus of this study is the management of procedural pain in adult male patients undergoing circumcision. Circumcision is a surgical procedure involving the removal of the foreskin or prepuce of the penis. In adult males, this surgical intervention is commonly indicated for primary medical conditions such as phimosis (the inability to retract the foreskin), paraphimosis, redundant prepuce causing hygiene problems, or recurr
Conditions
Interventions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who have health indications or personal preferences and have agreed to undergo an outpatient circumcision procedure. 2.Patients who have undergone a pre-operative health evaluation and possess no medical contraindications to receiving local anesthesia. 3.Patients who are able to communicate fluently and effectively in the Thai language. 4.Patients who have the cognitive capability to understand and evaluate their level of pain using the Numeric Rating Scale from zero to ten. 5.Patients who voluntarily provide written informed consent to participate in the research study before any protocol-specified procedures are initiated.
Exclusion criteria
Exclusion criteria: 1.Patients who have a documented medical history of hypersensitivity, allergic reactions, or adverse events related to local anesthetics, specifically lidocaine or other amide-type local anesthetic agents. 2.Patients who present with an active localized infection, acute inflammation, superficial skin lesions, open wounds, or dermatitis at the planned surgical site or the surrounding pelvic and pubic areas where the local anesthetic injection will be administered. 3.Patients who have been diagnosed with bleeding disorders, congenital coagulopathy, severe thrombocytopenia, or those who are currently receiving therapeutic anticoagulation therapy that cannot be safely discontinued before the surgical procedure, which increases the risk of hematoma or hemorrhage. 4.Patients with underlying neurovascular impairments, congenital structural abnormalities, or anatomical deformities of the penis that could technically interfere with the proper anatomical identification of the required injection landmarks or distort the distribution of the local anesthetic solution. 5.Patients who have a history of severe psychological disorders, cognitive impairments, or neurological conditions that significantly compromise their ability to understand instructions, cooperate with medical staff during the surgical procedure, or accurately report their pain scores using the subjective Numeric Rating Scale. 6.Patients who decline to participate in the clinical study or are unable to provide written informed consent voluntarily.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall procedure pain score Immediately after the completion of the surgical procedure. The severity of pain experienced by the patient throughout the entire surgical procedure, assessed using the Numeric Rating Scale . | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Intensity During Anesthetic Injection During the administration of the local anesthetic injection. The severity of pain experienced during the needle insertion and infiltration of the local anesthetic agent, assessed using the Numeric Rating Scale ranging,Postoperative Resting Pain Intensity 5 minutes after the completion of the surgical procedure while the patient is resting on the operative bed The severity of resting pain after the surgery, assessed using the Numeric Rating Scale ,Requirement for Rescue Anesthesia Intraoperatively, from the beginning of the skin incision until the end of suturing The requirement for additional pain relief during the surgery. Measured by the total volume in milliliters (ml) of supplementary,Incidence of Immediate Local Complications Intraoperatively and immediately up to 5 minutes after the completion of the surgical procedure. The occurrence of any localized adverse events or procedural complications, specifically noting the presence of hematoma (blood collection under the skin) or severe tissue edema (swelling) | — |
Countries
Thailand
Contacts
Lerdsin hospital