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

Not Applicable

Completed

• Conditions: Acute Post Operative Pain
• Interventions: Drug: ketorolac and light marcaine; Drug: Corticosteroids injection; Drug: Diclofenac Sodium Gel; Drug: light marcaine; Other: the standard analgesic protocol

• Registration Number: NCT06307106
• Lead Sponsor: Zagazig University

Brief Summary

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 randomized controlled comparative prospective clinical trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-14
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-12
• Primary Completion: 2024-10-14
• Study Completion: 2024-10-14
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A: ketorolac and light marcaine injection	ketorolac and light marcaine	-
group C: corticosteroids injection	Corticosteroids injection	-
group D: topical diclofenac sodium	Diclofenac Sodium Gel	-
group B: light marcaine injection	light marcaine	-
control group	the standard analgesic protocol	control group was given the ordinary analgesic protocol without local analgesic application

Primary Outcome Measures

Name	Time	Method
age	within 2 days before operation	adults from 18 to 60 years old
sex	within 2 days before operation	both sex were included
number of hemorrhoids	within 2 days before operation and intra-operatively	number of hemorrhoids clinically assessed
degree of hemorroids	within 2 days before operation and intra-operatively	degree of hemorroids clinically assessed
post operative pain	1st, 2nd 3rd, 7th, 14th days post-operatively	post operative assessed using visual analogue scale, minimum score is zero means painless and maximum score 10 means very painful
ambulation	from 1st to 3rd day post-operatively	early ambulation is evaluated in patients post-operatively
return to work	from one day to one month post-operatively	first time to return to work is evaluated
patient satisfaction	from one day to one month post-operatively	patient satisfaction about post-operative pain is assessed using customer satisfaction score. Minimum score is 0 and means very unsatisfied, maximum score is 10 and means very satisfied

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Egypt