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

NCT06307106 | Completed

• 1 other identifier: #40\14-Jan-2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Post Operative Pain

Keywords

hemorrhoidectomy; acute pain; corticosteroids

Outcome Measures

Primary Outcomes (8)

• age

  adults from 18 to 60 years old

  within 2 days before operation

• sex

  both sex were included

  within 2 days before operation

• number of hemorrhoids

  number of hemorrhoids clinically assessed

  within 2 days before operation and intra-operatively

• degree of hemorroids

  degree of hemorroids clinically assessed

  within 2 days before operation and intra-operatively

• post operative pain

  post operative assessed using visual analogue scale, minimum score is zero means painless and maximum score 10 means very painful

  1st, 2nd 3rd, 7th, 14th days post-operatively

• ambulation

  early ambulation is evaluated in patients post-operatively

  from 1st to 3rd day post-operatively

• return to work

  first time to return to work is evaluated

  from one day to one month post-operatively

• patient satisfaction

  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

  from one day to one month post-operatively

Study Arms (5)

group A: ketorolac and light marcaine injection

EXPERIMENTAL

Drug: ketorolac and light marcaine

group B: light marcaine injection

EXPERIMENTAL

Drug: light marcaine

group C: corticosteroids injection

EXPERIMENTAL

Drug: Corticosteroids injection

group D: topical diclofenac sodium

EXPERIMENTAL

Drug: Diclofenac Sodium Gel

control group

SHAM COMPARATOR

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

Other: the standard analgesic protocol

Interventions

ketorolac and light marcaine DRUG

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

group A: ketorolac and light marcaine injection

light marcaine DRUG

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

group B: light marcaine injection

Corticosteroids injection DRUG

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

group C: corticosteroids injection

Diclofenac Sodium Gel DRUG

topical application of Diclofenac Sodium Gel

group D: topical diclofenac sodium

the standard analgesic protocol OTHER

the routine analgesia was given without local analgesia application

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• both sex.
• age from 18 to 60.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, zagazig, 44519, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Ketorolac; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Reham Zakaria, PhD

  faculty of medicine Zagazig University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: January 14, 2024
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: April 8, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)