Efficacy of intradermal methylene blue injection for donor site pain relief: a randomised trial protocol

What is it about?

Background: Pain at the donor site of skin grafts remains a significant clinical challenge. Existing pain management approaches include topical agents, oral analgesics, and local anaesthetics, yet optimal strategies remain elusive. Methylene Blue (MB), known for its analgesic potential in various pain types, is being evaluated in this trial for its safety and efficacy when injected intradermally at donor sites following skin grafting Aim: To evaluate the safety and efficacy of intradermal injection of MB for pain relief at the donor site in patients undergoing split-thickness skin grafts (STSG), in comparison to standard dressing without MB. Methods: This single-center, randomised, parallel-group, active-controlled trial will enrol 60 adult patients undergoing STSG. Participants will be randomised into two groups: Intervention group (n=30) which will receive an intradermal MB injection at the donor site, while the control group (n=30) will receive standard tulle gras dressing. The primary outcome of this study is degree of pain relief achieved with the use of MB in split-skin grafting, measured by changes in Visual Analog Scale (VAS) scores at different time points postoperatively at 5th, 7th, 15th and 30th days. Secondary outcomes will include the requirement of analgesia, staining of the donor site, donor site healing (epithelisation) rate, scar quality, and adverse effects reported. Data analysis will include comparisons between the groups postoperatively, using independent statistical tests to assess intervention effects. Discussion: This trial aims to validate MB as a novel, low-cost analgesic intervention in postoperative care. If effective, it could improve patient comfort and recovery with minimal additional risk and may inform the development of more effective pain management strategies for the patient population.

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