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Clinical trial

Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study

ID
Name
#40\14-Jan-2024
Description
Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomizes comparative prospective clinical trial.
Trial arms
Trial start
2024-01-14
Estimated PCD
2024-07-14
Trial end
2024-07-14
Status
Active (not recruiting)
Treatment
ketorolac and light marcaine
local injection at surgical site of 30 mg ketorolac and 7-1.5 mg\\kg\\dose light marcaine
Arms:
group A: ketorolac and light marcaine injection
light marcaine
local injection at surgical site of 7-1.5 mg\\kg\\dose light marcaine
Arms:
group B: light marcaine injection
Corticosteroids injection
local injection at surgical site of 40 mg\\ dose of dexamethasone
Arms:
group C: corticosteroids injection
Diclofenac Sodium Gel
topical application of Diclofenac Sodium Gel
Arms:
group D: topical diclofenac sodium
Size
120
Primary endpoint
age
within 2 days before operation
sex
within 2 days before operation
number of hemorrhoids
within 2 days before operation and intra-operatively
degree of hemorroids
within 2 days before operation and intra-operatively
post operative pain
1st, 2nd 3rd, 7th, 14th days post-operatively
ambulation
from 1st to 3rd day post-operatively
return to work
from one day to one month post-operatively
patient satisfaction
from one day to one month post-operatively
Eligibility criteria
Inclusion Criteria: * both sex. * age from 18 to 60. Exclusion Criteria: * patient refusal. * patients with associated ano-rectal diseases such as fissures, fistulas, ano-proctitis, recurrent or thrombosed hemorrhoids and ano-rectal malignancy. * patients with liver cell failure. patients unfit for surgery according to American Society of Anesthesiologists.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2024-03-12

1 organization

4 products

1 indication

Organization
Zagazig University
Product
Ketorolac + Light Marcaine
Indication
Acute Postoperative Pain
Product
Light Marcaine
Product
Corticosteroids
Product
Diclofenac Sodium