Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries

Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery

Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.

Study Overview

• Status: Enrolling by invitation
• Conditions: Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl
• Intervention / Treatment: Drug: tramadol plus paracetamol; Drug: propofol and muscle relaxant (cisatracurium); Drug: Fentanyl; Drug: Propofol

Detailed Description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (T group and F group). Using computer generated randomization table; each group consists of 51 patients:Group (T) (n=51): Patients will receive preemptive intravenous infusion of tramadol plus paracetamol .

Group (F) (n=51): Patients will receive preemptive intravenous fentanyl.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • El Sharkia
    • Zagazig, El Sharkia, Egypt, 44519
      • Aculty of Medicine,Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for day case surgeries.
• Patient acceptance to be included into the study.
• Both sex.
• Patients with ASA physical status I, II.
• BMI 25 - 30 kg m-2.
• Duration of surgery from 1-2 hours

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.
• Patient on pain therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tramadol plus paracetamol (T)	Drug: tramadol plus paracetamol; 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 and muscle relaxant (cisatracurium) 0.15 mg/kg); Drug: propofol and muscle relaxant (cisatracurium); propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg)
Experimental: fentanyl(F)	Drug: Fentanyl; Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient followed by induction agents (propofol 2mg/kg).; Drug: Propofol; propofol 2mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enhanced recovery score	A 40-item questionnaire that provides a score (QoR-40) that measure quality of recovery after surgery and anesthesia (enhanced recovery) according to five aspects will be recorded at the end of 24 hours after surgery: Emotional state(n=9) physical comfort(n=12) Psychological support (n=7) physical independence(n=5) pain(n=7) - Each one of the 40 questions gets a score from one to five at which one is the worst response and five is the best response. When the individual score of all questions are added together we get a total score that ranges from 40 to 200.	at the end of 24 hour after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of PACU stay	time from patient admission to the PACU till discharge from the PACU	2 days postoperative
Duration of postoperative hospital stay	time from patient admission to the PACU till the hospital discharge admission to the PACU till the hospital discharge	2 days postoperative
Postoperative pain severity	(a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border).	recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based
postoperative agitation score	Score Term Description; 4 Combative Overtly combative, violent, immediate danger to staff; 3 Very agitated Pulls or removes tubes (s) or catheter(s); aggressive; 2 Agitated Frequent non-purposeful movement; 1 Restless Anxious, but not aggressive or vigorous 0 Alert and calm1 Drowsy Not fully alert but has sustained awakening (eye opening or eye contact) to voice (< 10 seconds)2 Light sedation Briefly awaken with eye contact to voice (> 10 seconds)3 Moderate sedation Movement or eye opening to voice (but no eye contact)-4 Deep sedation No response to voice, but movement or eye opening to physical stimulation5 Unarousable No response to voice or physical stimulation	immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU:

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: marwa M Medhat, MD, Zagazig University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): June 20, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: paracetamol ,tramadol , fentanyl, day case surgeries
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Neuromuscular Agents; Neuromuscular Blocking Agents; Fentanyl; Propofol; Acetaminophen; Tramadol; Cisatracurium
• Other Study ID Numbers: 459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No