Multimodal Analgesia for Cholecystectomy

NCT ID: NCT04788654

Last Updated: 2023-10-06

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2021-07-31

Brief Summary

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It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pharmacological group

Pharmacological analgesia will be performed

Group Type ACTIVE_COMPARATOR

Celebrex, acetaminophen, and dexamethasone

Intervention Type DRUG

Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.

Pharmacologican and surgical group

Pharmacological and surgical analgesia will be performed.

Group Type EXPERIMENTAL

Celebrex, acetaminophen, and dexamethasone

Intervention Type DRUG

Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.

Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum

Intervention Type PROCEDURE

Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.

Interventions

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Celebrex, acetaminophen, and dexamethasone

Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.

Intervention Type DRUG

Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum

Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.

Intervention Type PROCEDURE

Other Intervention Names

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Pharmacological Surgical

Eligibility Criteria

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Inclusion Criteria

* Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria

1. Recent gastric ulcer disease
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness
7. pregnancy
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Do-Hyeong Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Do-Hyeong Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2020-0494

Identifier Type: -

Identifier Source: org_study_id

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