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

NCT ID: NCT06307106

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-14

Study Completion Date

2024-10-14

Brief Summary

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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

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Conditions

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Acute Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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group A: ketorolac and light marcaine injection

Group Type EXPERIMENTAL

ketorolac and light marcaine

Intervention Type DRUG

local injection at surgical site of 30 mg ketorolac and 7-1.5 mg\\kg\\dose light marcaine

group B: light marcaine injection

Group Type EXPERIMENTAL

light marcaine

Intervention Type DRUG

local injection at surgical site of 7-1.5 mg\\kg\\dose light marcaine

group C: corticosteroids injection

Group Type EXPERIMENTAL

Corticosteroids injection

Intervention Type DRUG

local injection at surgical site of 40 mg\\ dose of dexamethasone

group D: topical diclofenac sodium

Group Type EXPERIMENTAL

Diclofenac Sodium Gel

Intervention Type DRUG

topical application of Diclofenac Sodium Gel

control group

control group was given the ordinary analgesic protocol without local analgesic application

Group Type SHAM_COMPARATOR

the standard analgesic protocol

Intervention Type OTHER

the routine analgesia was given without local analgesia application

Interventions

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ketorolac and light marcaine

local injection at surgical site of 30 mg ketorolac and 7-1.5 mg\\kg\\dose light marcaine

Intervention Type DRUG

light marcaine

local injection at surgical site of 7-1.5 mg\\kg\\dose light marcaine

Intervention Type DRUG

Corticosteroids injection

local injection at surgical site of 40 mg\\ dose of dexamethasone

Intervention Type DRUG

Diclofenac Sodium Gel

topical application of Diclofenac Sodium Gel

Intervention Type DRUG

the standard analgesic protocol

the routine analgesia was given without local analgesia application

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reham Zakaria Mohamed Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reham Zakaria, PhD

Role: STUDY_CHAIR

faculty of medicine Zagazig University

Locations

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Zagazig University Hospitals

Zagazig, zagazig, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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#40\14-Jan-2024

Identifier Type: -

Identifier Source: org_study_id

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