Pre-emptive cooling for reducing pain from local anaesthetic injections for hemorrhoidectomy

JRCT ID: jRCT1051210201

Registered date:23/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: hemorrhoid
• Date of first enrollment: 25/03/2022
• Target sample size: 50
• Study type: Interventional

Intervention(s)

This trial is a crossover design, and the order of anesthetic injections divides it into different two groups at random. In the case of Group1, we lead by anesthesia on the cooling side and perform anesthesia on the non-cooling side later. In the case of Group2, we lead by anesthesia on the non-cooling side and perform anesthesia on the cooling side later. The patient allocated for Group1 performs the injection of the first local anesthetic around hemorrhoids on the cooling side after putting an ice pack around hemorrhoids on the cooling side for two minutes. Then we give the injection of the second local anesthetic around hemorrhoids on the non-cooling side when two minutes that are washout period pass.
On the other hand, the patient allocated for Group2 performs the injection of the first local anesthetic around hemorrhoids on the non-cooling side. Then, we perform the second local anesthetic around hemorrhoids on the cooling side after having put an ice pack around hemorrhoids on the cooling side for two minutes.
We inject 1%Lidocaine (10 ml of 1 pipe) subcutaneously by 10 ml for each on the cooling side and the non-cooling side as a local anesthetic. But we do not randomize it about a kind, a dose, a side of the anesthetic.

Outcome(s)

• Primary Outcome: Visual Analogue Scale

Secondary Outcome

We check whether the first period curative effect has the carrying-over effect to a second period.
We check whether there is the difference of right and left in the hemorrhoids size.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. The patient who is going to be operated on for hemorrhoids between an ethic jury approval day and January 31, 2023
2. Age at the time of the agreement acquisition is 20 years or older
3. The patient that a written agreement is got by the free will of the person
4. Patient having the hemorrhoids of the Gori garfish classification grade III or IV degree
5. The patient who has hemorrhoids by one in each right and left

Exclude criteria

1. Patient with the past of the anal operation
2. The female patient who is nursing it during the pregnancy
3. The patient who is not given the informed consent that is effective by having by dementia and a mental disorder, a disease with the cognitive impairment
4. The patients with a history of the past with hypersensitivity for lidocaine
5. The patient who merges an anal fistula or an anal fissure
6. The patient who merges a neuropathy

Related Information

• Primary Sponsor: Yano Takaaki