Comparative evaluation the effect of preemptive subcutaneous infiltration of two doses of tramadol on post-operative pain of open kidney and urinary tract surgeries

Effect of preemptive subcutaneous infiltration of two doses of tramadol on post-operative pain of urologic surgeries, a double-blinded, randomized, placebo-controlled clinical trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT138804222159N1

Enrollment

Registered

2010-05-29

Start date

2010-06-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-operative pain after open urologic surgeries.

Interventions

Intervention 1: Tramadol, 1mg/kg in 10 cc normal saline 0/9%, with subcutaneous infiltration at the location of the incision, Before the incision. Intervention 2: Tramadol, 2mg/kg in 10 cc normal sali

Treatment - Drugs

Placebo

Tramadol, 1mg/kg in 10 cc normal saline 0/9%, with subcutaneous infiltration at the location of the incision, Before the incision

Tramadol, 2mg/kg in 10 cc normal saline 0/9%, with subcutaneous infiltration at the location of the incision, Before the incision

Tramadol, 10 cc normal saline 0/9%, with subcutaneous infiltration at the location of the incision, Before the incision

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 18-75 years old, candidates for urologic surgeries with ASA score I-II Exclusion criteria: history of opiate addiction, history of sensitivity to Tramadol, epilepsy or high ICP, chronic hepatic disease, chronic pain, obesity (BMI>30), taking of MAO inhibitors or SSRIs, any psychological or cognitional disorders that prevent the post operative evaluations, the lack of patient tendency to continue the trial for any reason

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Degree of pain. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: numeric rating scale.	—

Secondary

Measure	Time frame
Nausea and vomiting rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: nausea and vomiting score.;Pulse rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: count of pulse at a minute.;Sedation rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: sedation score.;Respiratory rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: count of respiratory rate at a minute.;Mean arterial pressure. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: ( 2 × systolic pressure + diastolic pressure ) / 3.	—

Measure

Time frame

Nausea and vomiting rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: nausea and vomiting score.;Pulse rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: count of pulse at a minute.;Sedation rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: sedation score.;Respiratory rate. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: count of respiratory rate at a minute.;Mean arterial pressure. Timepoint: 15, 30, and 60 minutes also 4, 8, 16, and 24 hours after surgery. Method of measurement: ( 2 × systolic pressure + diastolic pressure ) / 3.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Azim Honarmand

Isfahan University of Medical Sciences

honarmand@med.mui.ac.ir+98 31 1625 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026