Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries
- Conditions
- Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl
- Interventions
- Registration Number
- NCT06561672
- Lead Sponsor
- Zagazig University
- Brief Summary
Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 102
- 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
-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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tramadol plus paracetamol (T) tramadol plus paracetamol - tramadol plus paracetamol (T) propofol and muscle relaxant (cisatracurium) - fentanyl(F) Fentanyl - fentanyl(F) Propofol -
- Primary Outcome Measures
Name Time Method Enhanced recovery score at the end of 24 hour after surgery. 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.
- Secondary Outcome Measures
Name Time Method The duration of PACU stay 2 days postoperative time from patient admission to the PACU till discharge from the PACU
Duration of postoperative hospital stay 2 days postoperative time from patient admission to the PACU till the hospital discharge admission to the PACU till the hospital discharge
Postoperative pain severity recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border).
postoperative agitation score immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU: 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 calm
* 1 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 stimulation
* 5 Unarousable No response to voice or physical stimulation
Trial Locations
- Locations (1)
Aculty of Medicine,Zagazig University
🇪🇬Zagazig, El Sharkia, Egypt