Introduction
pruritus, urinary and bowel urgency, anal pain, pain
Medical lubricants are valuable tools and are important in the care process. Regulations require that lubricants are discreet, non-toxic and effective. In choosing a lubricant for a surgical procedure, care must be taken to ensure it is fit for purpose. It should be physiologically inert and stable at room and extreme pressuresLidocaine gel is commonly used for medical procedures in Ghana. However, it is not always available because of its prohibitive cost and procurement delays. Patients sometimes had to buy them at exorbitant prices from private pharmacies for procedures to be carried out, in addition, physicians may at times, resort to the usage of non-appropriate products to get around the situation. The use of inappropriate materials such as soapy water, chlorhexidine solutions and plain water have led to considerable discomfort and pain to patients.Shea butter is a widely available product obtained from the shea tree (Shea butter, which is known for its anti-inflammatory and antioxidant effects and because of its oily constituent could make a good replacement in areas where lidocaine gel is not available. The crude shea butter is used as a lubricant for surgical procedures in some Ghanaian hospitals however there is no available data on its use and efficacy as a medical lubricant. The main lubricants found in K-Y gel are glycerin and cellulose which are also found in the shea fruitThis novel shea lubricant is constituted from refined shea olein. Added to this is an acrylic acid polymer, an emulsifier (propylene glycol) and preservatives (methyl paraben and propyl paraben) to achieve a unique blend. It is sterilized by heating and stored under room temperature conditions away from direct sunshine. The product has also been subjected to physiochemical and microbiological analysis and stored in a collapsible sealed plastic tube.Cost analysis also showed that lidocaine gel is more expensive than plain lubricants. Chen and coworkersLidocaine gel remains the reference standard for most medical procedures as enumerated by several trials and meta-analysesIn this randomized controlled, single-blind non-inferiority trial, we compare a novel shea lubricant to 2% lidocaine gel, in terms of its effectiveness in reducing anal pain, discomfort, peri-anal pruritus, urinary and bowel urgency; and also assess the ease of use of the lubricants by clinicians during digital rectal examination.