NCT04788654

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

February 16, 2021

Last Update Submit

October 4, 2023

Conditions

Laparoscopic Cholecystectomy

Keywords

postoperative pain

Outcome Measures

Primary Outcomes (1)

  • Area under curve of postoperative pain for 24 hour

    Area under curve will be measured using Postoperative pain score at postoperative 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).

    At postoperative 24 hour

Secondary Outcomes (3)

  • Postoperative pain score,

    At postoperative 0, 2, 6, and 24 hour

  • Analgesic requirements,

    At postoperative 24 hour

  • Sleep quality

    At postoperative 24 hour

Study Arms (2)

Pharmacological group

ACTIVE COMPARATOR

Pharmacological analgesia will be performed

Drug: Celebrex, acetaminophen, and dexamethasone

Pharmacologican and surgical group

EXPERIMENTAL

Pharmacological and surgical analgesia will be performed.

Drug: Celebrex, acetaminophen, and dexamethasoneProcedure: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum

Interventions

Celebrex, acetaminophen, and dexamethasoneDRUG

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

Also known as: Pharmacological
Pharmacological groupPharmacologican and surgical group
Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneumPROCEDURE

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

Also known as: Surgical
Pharmacologican and surgical group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Recent gastric ulcer disease
  • Hepatic or renal insufficiency
  • Opioid dependency
  • Coagulopathy
  • Pre-existing neurologic or anatomic deficits in the lower extremities
  • Severe psychiatric illness
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Do-Hyeong Kim

Seoul, seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

CelecoxibAcetaminophenDexamethasoneSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 16, 2021

First Posted

March 9, 2021

Study Start

March 17, 2021

Primary Completion

July 30, 2021

Study Completion

July 31, 2021

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

KR(1)