Multimodal and Unimodal Analgesia in Cholecystectomy

NCT ID: NCT05547659

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Compare Unimodal and Multimodal Analgesics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

multimodal

pregabalin/ acetaminophen/ celecoxib

Group Type ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type DRUG

Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group

Acetaminophen 1 G Oral Tablet

Intervention Type DRUG

Acetaminophen 1 G Oral Tablet preoperative in multi-modal group

Celecoxib 400Mg Oral Capsule

Intervention Type DRUG

Celecoxib 400Mg Oral Capsule preoperative in multi-modal group

unimodal

Pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type DRUG

Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pregabalin 150mg

Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group

Intervention Type DRUG

Acetaminophen 1 G Oral Tablet

Acetaminophen 1 G Oral Tablet preoperative in multi-modal group

Intervention Type DRUG

Celecoxib 400Mg Oral Capsule

Celecoxib 400Mg Oral Capsule preoperative in multi-modal group

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing laparoscopic cholecystectomy
* Patients older than 18 years old

Exclusion Criteria

* Renal or hepatic or cardiac impairment patients
* Patients with chronic pain history
* Allergic patients after taking aspirin or other NSAIDs
* patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role collaborator

October 6 University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

engy wahsh

head of clinical pharmacy unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beni suef University hospital

Banī Suwayf, , Egypt

Site Status

Beni-Suef Hospital

Banī Suwayf, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FWA00015574

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.