NCT07049380

Brief Summary

This study aims to compare pain severity and analgesic requirements between smokers and nonsmokers following laparoscopic cholecystectomy, evaluating the efficacy of two analgesics, tramadol and nalbuphine.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

March 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 25, 2025

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    The Visual Analog Scale (VAS) is a tool used to measure pain intensity, mood, or other subjective experiences. It typically involves a 10 cm (100mm) line with descriptive anchors at each end, such as "no pain" and "worst pain imaginable

    12 Months

Interventions

evaluating the efficacy of two analgesics, tramadol and nalbuphine. The primary objectives are to estimate pain severity in smokers versus nonsmokers and identify the effect of tramadol and nalbuphine between these groups

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study anticipates revealing significant variations in pain perception and analgesic requirements, potentially guiding tailored perioperative protocols for smokers. By addressing gaps in pain management strategies specific to smoking status, this research could enhance postoperative recovery outcomes and inform clinical practices for optimizing analgesia in diverse patient populations.

You may qualify if:

  • Both Male and female patients are included.
  • Adults' patients with Greater than 30 years of age
  • Both Smoker and non-Smokers patients are added (Patients who are chain smoker at least 10 cigarettes per day).

You may not qualify if:

  • Patients are excluded if they have smoking history other than cigarettes smoking like Vapes, Cigar and smokeless tobacco.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allama Iqbal Teaching hospital

Dera Ghazi Khan, Punjab Province, Pakistan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 3, 2025

Study Start

March 17, 2025

Primary Completion

August 1, 2025

Study Completion

February 28, 2026

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations