Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

NCT ID: NCT05990686

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-09-30

Brief Summary

Postoperative pain is an important problem, especially for day case surgeries. It has negative effects on patient's hemodynamics and can cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.

Multiple analgesic strategies have been proposed including NSAID, opioids, epidural analgesia. Each of them has its limitations.

In this study the investigators will compare between the effect of preemptive use of paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative pain

Detailed Description

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, non invasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.

Patients will be allocated into two equal groups;

Group (T) (n=66):

Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anesthesia (induction agent will be Propofol 2mg/kg)

Group ( F ) (n=66):

Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by induction agents ( Propofol 2mg/kg).

In both groups intraoperative monitoring of heart rate (beat/min) and mean arterial blood pressure (mm gh) will be documented.

Postoperatively:

In the recovery room and in the surgical ward patient's mean blood pressure and heart rate will be measured and recorded at 1, 2, 4, 6, and 12 hours postoperatively. Also the postoperative pain assessment for all patients will be done by an anesthesiologist (independent observer) at 1, 2, 4, 6 and 12 hours after surgery based on visual analog scale (VAS) ( a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border). The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced.

Standard postoperative analgesia consisted of paracetamol 1gm i.v. after 6 hours. A rescue analgesic diclofenac 75mg IV infusion will be applied to patients if their VAS score was ≥ 3 and if paracetamol had been administered less than 6 hours before. Time of first required dose of rescue analgesic and total rescue analgesic consumption over the 24-h study period will be documented.

Rescue antiemetics will be given to any patient complaining of nausea and vomiting, occurrence of other side effects including bradycardia or hypotension will be recorded and managed (hypotension defined as a decrease in mean arterial pressure (MAP) of more than 20% of baseline value and planned to be treated with crystalloid infusion and 5 mg bolus of ephedrine, Bradycardia is considered if the heart rate (HR) went below 50 b/min and planned to be managed with atropine 0.2-0.5 mg). Patient satisfaction and length of postoperative hospital stay will also be recorded.

Conditions

Post Operative Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

paracetamol plus tramadol

randomized selection of 66 adult patients

Tramadol Hydrochloride

Intervention Type: DRUG

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.

Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anaesthesia (induction agent will be Propofol 2mg/kg)

fentanyl

randomized selection of 66 adult patients

Fentanyl injection

Intervention Type: DRUG

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started...Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by induction agents ( propofol 2mg/kg).

.

Interventions

Tramadol Hydrochloride

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.

Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anaesthesia (induction agent will be Propofol 2mg/kg)

Intervention Type: DRUG

Fentanyl injection

After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started...Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by induction agents ( propofol 2mg/kg).

.

Intervention Type: DRUG

Other Intervention Names

tramadol; fentanyl

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for day case surgeries.
• Both sex
• Patient's age 21 - 60 years.
• Patients with ASA physical status I, II.
• BMI 25 - 30 kg m-2.

Exclusion Criteria

• Uncooperative patients and patients with psychological problems.
• Patients with liver or renal impairment..
• Patients with history of allergy to drug used in the study.
• Patients with chronic pain.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michael Adel Shaker

lecturer of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MICHAEL A shaker, lecturer

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University , Fuculty of Medicine

Zagazig, Sharquia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

michael A shaker, lecturer

Role: CONTACT

michaeladelshaker@yahoo.com

01220647566 ext. 002

salwa S el sherbeny, lecturer

Role: CONTACT

dr_salwa86@yahoo.com

01128595629 ext. 002

Facility Contacts

sahar M el gammal, professor

Role: primary

01000089606 ext. 002

Other Identifiers

9702/19-10-2022

Identifier Type: -

Identifier Source: org_study_id