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.

Study Overview

• Status: Completed
• Conditions: Acute Post Operative Pain
• Intervention / Treatment: Drug: ketorolac and light marcaine; Drug: light marcaine; Drug: Corticosteroids injection; Drug: Diclofenac Sodium Gel; Other: the standard analgesic protocol

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Zagazig University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A: ketorolac and light marcaine injection	Drug: ketorolac and light marcaine; local injection at surgical site of 30 mg ketorolac and 7-1.5 mg\kg\dose light marcaine
Experimental: group B: light marcaine injection	Drug: light marcaine; local injection at surgical site of 7-1.5 mg\kg\dose light marcaine
Experimental: group C: corticosteroids injection	Drug: Corticosteroids injection; local injection at surgical site of 40 mg\ dose of dexamethasone
Experimental: group D: topical diclofenac sodium	Drug: Diclofenac Sodium Gel; topical application of Diclofenac Sodium Gel
Sham Comparator: control group; control group was given the ordinary analgesic protocol without local analgesic application	Other: the standard analgesic protocol; the routine analgesia was given without local analgesia application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Chair: Reham Zakaria, PhD, Faculty of Medicine Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2024
• Primary Completion (Actual): October 14, 2024
• Study Completion (Actual): October 14, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: acute pain; hemorrhoidectomy; corticosteroids
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Bupivacaine; Ketorolac; Analgesics; Diclofenac
• Other Study ID Numbers: #40\14-Jan-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After completion the study, interested researchers can contact us for providing any data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No