Pain Modality Treatment After Hemorrhoidectomy

Around the Clock Pain Treatment Modality Offer Better Pain Control and Less Opiates Drugs Use

Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences.

The objective is to corroborate which pain treatment modality is better in patients after hemorrhoidectomy.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Pain, Procedural
• Intervention / Treatment: Other: Pain scale registry

Detailed Description

Patients who have undergone a hemorrhoidectomy are included in the study, the pain treatment modality is conceived by the treating surgeon or anesthesiologist. The first modality is to administer pain killers on-demand depending on visual analog scales of pain and the second modality to give pain killers on determined hours.

• Study Type: Observational
• Enrollment (Actual): 5335

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients that underwent elective hemorrhoidectomy

Description

Inclusion Criteria:

Elective surgery for hemorrhoids

Exclusion Criteria:

Mental retardation Incapacitated patient Under 18 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Around the clock analgetic treatment; Patients that underwent hemorrhoidectomy and pain killers are prescribed every specific hour independent of pain degree, if necessary drugs can be administered on demand.	Other: Pain scale registry; The nurses ask the patient about the pain filling every two hours during the hospitalization.
On demand analgetic treatment; A pain killers list is prescribed by the physician and the nurse decides which drug to administer depending on a protocol of treatment based on the visual analog scale.	Other: Pain scale registry; The nurses ask the patient about the pain filling every two hours during the hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain medition	The pain registred is analyze as maximum, mean and on discharge.	Immediately after the intervention/procedure/surgery
Drugs Administred	The amount of drugs administred to each patients is analyzed	Immediately after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Assuta Medical Center
• Investigators: Principal Investigator: Sergio G Susmallian, MD, Assuta Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: July 3, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 3, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Pain killers
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Pain, Procedural
• Other Study ID Numbers: 12-2020 (Other Identifier: Ifakara Health Institute Review Board (Tanzania))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will be sent to the accepting journal study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No