The Effect of Body Mass Index In Relation To Menstrual Cycle Phase on Propofol Injection Pain

There are suggestions from experimental pain studies that pain perception in patients with severe obesity differs compared with individuals with lower BMI values, with a tendency for patients with severe obesity to be hypoalgesic - that is, to have reduced numerical pain scores to a variety of painful stimuli. That finding could be related to: associated reduced cognitive function (complex attention, verbal and visual memory, and decision making) in severe obesity.

The purpose of this study is to determine differences between females' pain levels whether they are obese or non-obese, during different menstrual phases (premenstrual, postmenstrual and menopausal phases) through propofol injection pain given for induction of GA

Study Overview

• Status: Completed
• Conditions: Propofol Adverse Reaction; Injection Site Coldness
• Intervention / Treatment: Drug: Non obese; Drug: Obese.

Detailed Description

• Study population Ninety patients, 18 years - 65yor older, physical status ASA I&II, scheduled to undergo elective gynecological surgery, will be enrolled in this prospective observational study.
• Patients' recruitment Patients will be recruited after admission to the hospital, same day they scheduled for surgery. All women who will meet inclusion criteria and gave written informed consent for participation in the study will be enrolled.

Patients will be divided into 2 groups according to BMI levels: Non obese (whether normal weight or overweight) = Group "NO" and obese = Group "O". Normal weight is defined as BMI 18.5-24.9, overweight as BMI 25.0-29.9 and obesity as BMI ≥ 30. [8] This study is a single blind study, where patients are aware of their menstrual status but supporting examiner is not aware of the patients' menstrual status.

Patients will be instructed on a vertical VAS 0-10 cm where (0) is marked as no pain and (10) is marked as the worst pain ever felt After standard anesthesia monitoring, Administration of oxygen will be performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose will be injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients will be observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset will be documented (to differentiate early or late type of pain).

Another anesthesiologist, who is unaware of the study groups, will assess the intensity of pain after propofol injections.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

18 years - 65yor older, physical status ASA I&II, scheduled to undergo elective surgery, were enrolled in this prospective observational study

Description

Inclusion Criteria:

• 18 years - 65yor older,
• physical status ASA I&II

Exclusion Criteria:

• irregular menstrual cycle,
• those who received hormonal therapy for any cause,
• on oral contraceptive pills,
• breast feeding,
• pregnant,
• history of total abdominal hysterectomy and/or bilateral salphingo-opherectomy.
• patients who had difficulty in understanding the visual analogue scale (VAS)/ pain scoring systems,
• renal or hepatic insufficiency,
• anticipated difficult tracheal intubation, and
• hypersensitivity to the study drugs.
• Also, patients on antidepressants and analgesics

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non obese; Non obese (whether normal weight or overweight) = Group "NO"	Drug: Non obese; After standard anesthesia monitoring, Administration of oxygen was performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose was injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients were observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset was documented (to differentiate early or late type of pain).; Other Names: Group NO
Obese; obese = Group "O"	Drug: Obese.; After standard anesthesia monitoring, Administration of oxygen was performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose was injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients were observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset was documented (to differentiate early or late type of pain).; Other Names: Group O

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	Incidence & severity of propofol injection pain (Mild pain was defined as VAS score 0-3, Moderate as VAS score 4-6, Severe as VAS score 7-10).	immediately after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Propofol injection pain, early or late (after 10 seconds)	Type of Propofol injection pain, early or late (after 10 seconds)	after 10 seconds
Hemodynamic variables	Hemodynamic variables were recorded before administration of the IV anesthetic, as well as after TI and 5 minutes later	till 5 minutes after tracheal intubation
Rate pressure products	Rate pressure products were calculated (an indicator of the heart's demand for oxygen) at same hemodynamic predetermined measuring timings.	till 5 minutes after tracheal intubation

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Raham H Mostafa, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Menopause; Menstrual cycle; Luteal phase; Body mass index; Visual analogue scale; Injection pain; Follicular phase
• Other Study ID Numbers: R43/2019 (Registry Identifier: Ain Shams research ethical committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Excel Sheet, individual deidentified participant data will be shared study protocol, statistical analysis plan will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No