Gender and Opioid Consumption (GenderOpioid)

Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, Opioid related complications (respiratory depression, Nausea & vomiting, itching, over-sedation, delayed intestinal motility).

Study Overview

• Status: Unknown
• Conditions: Postoperative; Parotitis
• Intervention / Treatment: Drug: postoperative morphine

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I and II Cases scheduled for elective intraabdominal surgeries

Exclusion Criteria:

• diabetes,
• postmenopausal females,
• laparoscopic surgery,
• regional anesthesia emergency procedures,
• sepsis,
• hepatectomy,
• Renal impairment, and
• hepatic impairment,
• mental and psychiatric disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Male group; All male patients scheduled for upper abdominal surgeries	Drug: postoperative morphine; Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.
Active Comparator: Female group; All female patients scheduled for upper abdominal surgeries	Drug: postoperative morphine; Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative morphine consumption	24 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: December 27, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Estimate): December 30, 2016
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Parotid Diseases; Sialadenitis; Parotitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: GenderOpioids

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided