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

Phase 3

Completed

• Conditions: Effect of Drug; Analgesia
• Interventions: Drug: fentanyl, group-F administered as an active comparator; Drug: paracetamol, the group P

• Registration Number: NCT04762147
• Lead Sponsor: Aga Khan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2021-02
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl group-F	fentanyl, group-F administered as an active comparator	Fentanyl 2mcg/kg was administered at the time induction of anaesthesia
Paracetamol group-P	paracetamol, the group P	Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery

Primary Outcome Measures

Name	Time	Method
Intra-operative pain assessment was based on changes in each five minutes interval in heart rate	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	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
Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia	15 minutes post-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
Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure	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	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
Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure	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	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
Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia	30 minutes post-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
Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia	Immediately post-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