NCT05884268

Brief Summary

Recent studies on the impact of perioperative venlafaxine for treatment of acute postoperative pain have yielded positive outcomes . The aim of the present study is to investigate the role of perioperative venlafaxine on the management of postoperative pain in patients undergoing LC.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for phase_1

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

May 22, 2023

Last Update Submit

May 22, 2023

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Change in postoperative pain between the two groups using visual analogue score (VAS)

    pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain) pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain)

    24 Hours postoperative

Secondary Outcomes (1)

  • Postoperative nausea and vomiting (PONV)

    24 Hours postoperative

Study Arms (2)

Laparoscopic Cholecystectomy

ACTIVE COMPARATOR
Drug: Venlafaxine

Control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VenlafaxineDRUG

Patients scheduled for elective LC will receive 150 mg venlafaxine before surgery

Laparoscopic Cholecystectomy
PlaceboDRUG

Patients scheduled for elective LC will receive placebo venlafaxine before surgery

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients who are scheduled to undergo elective LC

You may not qualify if:

  • Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

May 30, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

June 1, 2023

Record last verified: 2023-05