Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

Post Operative Pain Clinical Trial

Official title:

Preemptive Intravenous Paracetamol Plus Tramadol Versus Preemptive Intravenous Fentanyl in Day Case Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990686
• Other study ID #: 9702/19-10-2022
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Zagazig University
• Contact: michael A shaker, lecturer
• Phone: 01220647566
• Email: michaeladelshaker[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• 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)
• 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). .

Locations

Country	Name	City	State
Egypt	Zagazig University , Fuculty of Medicine	Zagazig	Sharquia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative analgesia	Assess quality of postoperative analgesia in both groups analogue score (VAS) scale where zero means no pain and ten means worst pain	immediately postoperative (0 hour), 1 hour, 2 hours , 4 hours, 6 hours and 12 hours
Secondary	mean arterial Blood pressure	Compare mean arterial blood pressure in (mm hg) between patients in both groups	5 minutes after start of surgery (intraoperative) , immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery
Secondary	rescue analgesic	document the first time for the need of rescue analgesics	immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery
Secondary	side effects	document the incidence of side effects including: bradycardia, hypotension, nausea and vomiting	up to twenty four hours after surgery
Secondary	length of hospital stay	Compare the length of hospital stay in both groups	up to twenty four hours after surgery
Secondary	Heart Rate	compare the heart rate in rate per minutes (rpm) between patients in both groups	5 minutes after start of surgery ( intraoperative), immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery