Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries

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

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

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Tramadol Hydrochloride; Drug: Fentanyl injection

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.

• Study Type: Observational
• Enrollment (Estimated): 132

Contacts and Locations

• Study Contact: Name: michael A shaker, lecturer; Phone Number: 002 01220647566; Email: michaeladelshaker@yahoo.com
• Study Contact Backup: Name: salwa S el sherbeny, lecturer; Phone Number: 002 01128595629; Email: dr_salwa86@yahoo.com

Study Locations

• Egypt
  • Sharquia
    • Zagazig, Sharquia, Egypt, 7120730
      • Recruiting
      • Zagazig University , Fuculty of Medicine
      • Contact: sahar M el gammal, professor; Phone Number: 002 01000089606

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

patients scheduled for a day case surgeries

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
paracetamol plus tramadol; randomized selection of 66 adult patients	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); Other Names: tramadol
fentanyl; randomized selection of 66 adult patients	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). .; Other Names: fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
side effects	document the incidence of side effects including: bradycardia, hypotension, nausea and vomiting	up to twenty four hours after surgery
length of hospital stay	Compare the length of hospital stay in both groups	up to twenty four hours after surgery
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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: MICHAEL A shaker, lecturer, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Tramadol
• Other Study ID Numbers: 9702/19-10-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No