Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy

Study Overview
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Brief Summary
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Objective of study: To compare the efficacy of intravenous paracetamol and fentanyl for intra-operative and post-operative pain relief in patients undergoing diagnostic and therapeutic hysteroscopy. Hypothesis of study: There is no difference in pain control between intravenous fentanyl and paracetamol in patients undergoing hysteroscopy.

Detailed Description
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Intraoperative pain assessment will be based on: Hemodynamic vital (SBP, DBP. MAP and HR) increase 20% from the baseline will be observed and assumed pain. Postoperative pain assessment will be based on: Mean Pain score :Visual analogue pain scale (VAS) of 0-10 cms will be used to assess the pain at the end of the procedure. Diagnostic hysteroscopy: Patients presenting with abnormal premenopausal or postmenopausal uterine bleeding, pain, infertility, intrauterine adhesions, endometrial biopsy, foreign body. Therapeutic hysteroscopy: To remove IUD, uterine polyps, fibroid, foreign body and submucosal fibroids, sterilization.

Official Title
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Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy

Conditions
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Analgesia, Effect of Drug

Intervention / Treatment
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* Drug: paracetamol, the group P
* Drug: fentanyl, group-F administered as an active comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery American Society of Anaesthesiologists (ASA) grade I & II Exclusion Criteria: Patients with anticipated difficult airway Gastro-oesophageal reflux disorder Body mass index (BMI) >30kg/m2 Known Hepatic disorder Known ischemic heart disease History of hypersensitivity reactions to paracetamol and fentanyl or already taking paracetamol and fentanyl Patient experiencing the iatrogenic intra-operative uterine perforation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol group-P<br>Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery | Drug: paracetamol, the group P<br>* The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy<br>|
| Active Comparator: Fentanyl group-F<br>Fentanyl 2mcg/kg was administered at the time induction of anaesthesia | Drug: fentanyl, group-F administered as an active comparator<br>* The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure | To assess the intra-operative pain by changes in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure rising from the 20 percent of baseline value were considered that the patient is experiencing pain | Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure | 
| Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure | To assess the intra-operative pain by changes in hemodynamic parameters such as mean arterial blood pressure rising from the 20 percent of baseline value were considered that the patient is experiencing pain | Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure | 
| Intra-operative pain assessment was based on changes in each five minutes interval in heart rate | To assess the intra-operative pain by changes in hemodynamic parameters such as heart rate rising from the 20 percent of the baseline value were considered that the patient is experiencing pain | Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure | 
| Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia | To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit. Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10 | Immediately post-anaesthesia | 
| Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia | To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit. Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10 | 15 minutes post-anaesthesia | 
| Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia | To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit. Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10 | 30 minutes post-anaesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy