Pain Modality Treatment After Hemorrhoidectomy

• Sponsor: Assuta Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04953182
• Collaborator: (none)
• Enrollment: 5,335
• Actual Duration (Months): 58.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute; Pain, Procedural	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 Design

• Study Type: Observational
• Actual Enrollment: 5335 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Around the Clock Pain Treatment Modality Offer Better Pain Control and Less Opiates Drugs Use
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: May 30, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Pain medition [Immediately after the intervention/procedure/surgery]

   The pain registred is analyze as maximum, mean and on discharge.

2. Drugs Administred [Immediately after the intervention/procedure/surgery]

   The amount of drugs administred to each patients is analyzed

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Elective surgery for hemorrhoids

Exclusion Criteria:

Mental retardation Incapacitated patient Under 18 years old

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assuta Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sergio Gabriel Susmallian, Head of the department of general surgery, Assuta Medical Center
• ClinicalTrials.gov Identifier: NCT04953182
• Other Study ID Numbers: 12-2020
• First Posted: Jul 7, 2021
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sergio Gabriel Susmallian, Head of the department of general surgery, Assuta Medical Center: Pain killers
• Additional relevant MeSH terms: Acute Pain; Pain, Procedural

Study Results

No Results Posted as of Jul 7, 2021