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OpenTrials
Completed

NCT Number: NCT06307106

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

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.

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Key information

Conditions

Acute Post Operative Pain Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University Hospitals

Zagazig, zagazig, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketorolac and light marcaine

Drug

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

light marcaine

Drug

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

Corticosteroids injection

Drug

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

Diclofenac Sodium Gel

Drug

topical application of Diclofenac Sodium Gel

the standard analgesic protocol

Other

the routine analgesia was given without local analgesia application

Primary outcomes

  1. age

    Time frame: within 2 days before operation

    adults from 18 to 60 years old

  2. sex

    Time frame: within 2 days before operation

    both sex were included

  3. number of hemorrhoids

    Time frame: within 2 days before operation and intra-operatively

    number of hemorrhoids clinically assessed

  4. degree of hemorroids

    Time frame: within 2 days before operation and intra-operatively

    degree of hemorroids clinically assessed

  5. post operative pain

    Time frame: 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

  6. ambulation

    Time frame: from 1st to 3rd day post-operatively

    early ambulation is evaluated in patients post-operatively

  7. return to work

    Time frame: from one day to one month post-operatively

    first time to return to work is evaluated

  8. patient satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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