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

Primary Purpose

Analgesia, Effect of Drug

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
paracetamol, the group P
fentanyl, group-F administered as an active comparator
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Paracetamol group-P

    Fentanyl group-F

    Arm Description

    Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery

    Fentanyl 2mcg/kg was administered at the time induction of anaesthesia

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2021
    Last Updated
    February 18, 2021
    Sponsor
    Aga Khan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04762147
    Brief Title
    Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
    Official Title
    Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia, Effect of Drug
    Keywords
    ParacetamolGeneral anaesthesia, Fentanyl, General Anaesthesia, Hysterescopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paracetamol group-P
    Arm Type
    Experimental
    Arm Description
    Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery
    Arm Title
    Fentanyl group-F
    Arm Type
    Active Comparator
    Arm Description
    Fentanyl 2mcg/kg was administered at the time induction of anaesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    paracetamol, the group P
    Intervention Description
    The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl, group-F administered as an active comparator
    Intervention Description
    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 Outcome Measure Information:
    Title
    Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure
    Description
    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
    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
    Title
    Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure
    Description
    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
    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
    Title
    Intra-operative pain assessment was based on changes in each five minutes interval in heart rate
    Description
    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
    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
    Title
    Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia
    Description
    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
    Time Frame
    Immediately post-anaesthesia
    Title
    Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia
    Description
    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
    Time Frame
    15 minutes post-anaesthesia
    Title
    Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia
    Description
    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
    Time Frame
    30 minutes post-anaesthesia

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Hysteroscopy is procedure perfomed in females only
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dileep Kumar, FCPS
    Organizational Affiliation
    Aga Khan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All IPD data will be shared through the publication but without the sharing the participants identities.
    IPD Sharing Time Frame
    After recruitment of sample size
    IPD Sharing Access Criteria
    The data can be accessed by requesting the institutional ethical review committee and falling under the category of data sharing
    Citations:
    PubMed Identifier
    25788774
    Citation
    Ali MA, Shamim F, Chughtai S. Comparison between intravenous paracetamol and fentanyl for intraoperative and postoperative pain relief in dilatation and evacuation: Prospective, randomized interventional trial. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):54-8. doi: 10.4103/0970-9185.150542.
    Results Reference
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    Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy

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