Efficacy of Tumescent Analgesia using Lidocaine, Bupivacaine, or a Combination ?for Donor Site Pain Management after Split-Thickness Skin Graft Surgery.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260503001

Enrollment

Registered

2026-05-03

Start date

2025-09-18

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who underwent split-thickness skin graft procedure Split-thickness skin graft, lidocaine, bupivacaine, donor site pain

Interventions

Preparation : Tumescent analgesia using 2%lidocaine without adrenaline (20 mL), normal saline (180 mL), and adrenaline (1:1000) (1 mL). Mode of administration : Injected in the subcutaneous layer at t

s body weight as the maximum dosage of lidocaine,Preparation : Tumescent analgesia using 0.5%bupivacaine without adrenaline (20 mL), normal saline (180 mL), and adrenaline (1:1000) (1 mL). Mode of adm

s body weight as the maximum dosage of bupivacaine,Preparation : Tumescent analgesia using 2%lidocaine without adrenaline (20 mL), 0.5%bupivacaine (20 mL), normal saline (160 mL), and adrenaline (1:10

s body weight as the maximum dosage of lidocaine

Active Comparator Drug,Experimental Drug,Experimental Drug

Lidocaine,Bupivacaine,Combine

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. patient who underwent STSG procedure and used thigh area as a donor site 2. inpatient hospitalization

Exclusion criteria

Exclusion criteria: 1. chronic opioid used 2. allergic history of lidocaine, bupivacaine 3. allergic history of sevoflurane, dexamethasone, parecoxib, fentanyl, acetaminophen with codeine, morphine 4. pregnancy 5. predicted donor site area more than 2 times of maximum tumescent analgesic solution 6. patient who does not consent in this study

Design outcomes

Primary

Measure	Time frame
resting pain score at 24 hours 24 hours after tumescent analgesia injection numeric rating scales,dynamic pain score at 24 hours 24 hours after tumescent analgesia injection numeric rating scales	—

Secondary

Measure	Time frame
resting pain score 6, 12, 18 hours after tumescent analgesia injection and once daily for 7 days numeric pain scales,dynamic pain score 6, 12, 18 hours after tumescent analgesia injection and once daily for 7 days numeric pain scales,pain score during opioid injection at the time of morphine injection within 24 hours numeric pain scales,time to first dose opioid time to first dose of morphine injection minutes,total opioid usage in 24 hours within 24 hours after tumescent analgesia injection milligram,total opioid usage after tumescent analgesia injection to healed wound milligram,pain score at wound opening at the time of donor site wound opening numeric pain scales,donor site symptoms after tumescent analgesia injection to healed wound yes or no (itching, tense, warm),donor site complications within 30 days after tumescent analgesia injection yes or no (bleeding, infection),drug complications after tumescent analgesia injection to healed wound yes or no	—

Measure

Time frame

resting pain score 6, 12, 18 hours after tumescent analgesia injection and once daily for 7 days numeric pain scales,dynamic pain score 6, 12, 18 hours after tumescent analgesia injection and once daily for 7 days numeric pain scales,pain score during opioid injection at the time of morphine injection within 24 hours numeric pain scales,time to first dose opioid time to first dose of morphine injection minutes,total opioid usage in 24 hours within 24 hours after tumescent analgesia injection milligram,total opioid usage after tumescent analgesia injection to healed wound milligram,pain score at wound opening at the time of donor site wound opening numeric pain scales,donor site symptoms after tumescent analgesia injection to healed wound yes or no (itching, tense, warm),donor site complications within 30 days after tumescent analgesia injection yes or no (bleeding, infection),drug complications after tumescent analgesia injection to healed wound yes or no

—

Countries

Thailand

Contacts

Public ContactSahapat Charoenratana

Ramathibodi hospital

sahapat.md@gmail.com022011315

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Jun 29, 2026