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Completed

NCT Number: NCT04762147

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

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.

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Key information

Conditions

Analgesia Agnosia Effect of Drug Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paracetamol, the group P

Drug

The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy

fentanyl, group-F administered as an active comparator

Drug

The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy

Primary outcomes

  1. Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure

    Time frame: 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

  2. Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure

    Time frame: 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

  3. Intra-operative pain assessment was based on changes in each five minutes interval in heart rate

    Time frame: 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

  4. Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia

    Time frame: 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

  5. Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia

    Time frame: 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

  6. Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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