Clinical trial NCT04762147: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Effect of Drug
Keywords: ParacetamolGeneral anaesthesia
Fentanyl
General Anaesthesia
Hysterescopy
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure
timeFrame: 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
measure: Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure
timeFrame: 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
measure: Intra-operative pain assessment was based on changes in each five minutes interval in heart rate
timeFrame: 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
measure: Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia
timeFrame: Immediately post-anaesthesia
measure: Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia
timeFrame: 15 minutes post-anaesthesia
measure: Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia
timeFrame: 30 minutes post-anaesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aga Khan University
name: Dileep Kumar, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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.