Health Condition 1: L768- Other intraoperative and postprocedural complications of skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Field block anaesthesia: Subdermal circumferential anesthesia given approximately 10 mm outside the planned elliptical excision, using 2 percentage lignocaine with adrenaline (1:200000)
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged more than or equal to 18 years who provide written informed consent. 2.Patients with benign or suspected benign cutaneous lesions on the trunk or extremities. 3.Lesion size 0.5 to 2.5 cm in longest pre injection diameter. 4.Planned simple elliptical excision with primary closure under local anesthesia
Exclusion criteria
Exclusion criteria: 1.Lesions on face, scalp, periungual area, genitals, or perineum (where named nerve block is standard). 2.Local infection, cellulitis, or edema at the operative site. 3. Known allergy or contraindication to lignocaine or adrenaline (e.g., arrhythmia, hyperthyroidism, pheochromocytoma). 4.Coagulopathy or anticoagulant therapy unsuitable for skin surgery. 5.Recurrent lesions or prior surgery at the same site. 6.Complex reconstruction planned (flap, graft, or secondary intention healing). 7.Inability to cooperate or comply with anesthesia testing or follow-up. Lesion Selection (for patients with multiple eligible lesions) If a participant has more than one eligible lesion, only one will be enrolled to maintain independence of observations. Selection will follow this hierarchy: 1.The most superior (cephalad) lesion is chosen. 2.If two lesions lie at the same vertical level, the left-sided lesion is chosen. 3.For midline pairs at the same level, the more proximal (closer to the trunk) lesion is selected. Selection will be finalized before randomization and recorded in the screening log; no substitution will be allowed if the selected lesion later becomes ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Distortion Index (CDI) at 120 seconds following anaesthetic injection- expressed as percentage change in ellipse geometryTimepoint: intraoperative 120 seconds after anaesthetic injection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.CDI at 60 seconds. 2.CDI at 180 seconds. 3.Injection pain NRS (0-10). 4.Rescue anaesthesia requirement(Y/N) and rescue volume (mL). 5.Time to onset of anaesthesia (seconds). 6.Complications at 7-10 days (haematoma, infection, dehiscence). 7.Surgeon ease-of-technique or workflow using Likert scale (1-5). 8.Cosmetic outcome at 8 weeks assessed by POSAS or VAS 9.Patient satisfaction at 8 weeks assessed by Likert scale(1-5) Timepoint: intraoperative, 1 week after procedure, 8 weeks after procedure | — |
Countries
India
Contacts
Public ContactDr Sheetanshu Kumar
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed