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Oral Duloxetine as a Premedication for Postoperative Pain Control

Primary Purpose

Anesthesia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Duloxetine 60mg
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists I or II.
  • Sex: Both sexes.
  • Age between 18 and 50.
  • Height 155-180 cm.
  • Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.

Exclusion Criteria:

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • Had a history of drug or alcohol abuse.
  • Taking opioids or sedative medications.
  • Inability to communicate with patients to evaluate the postoperative pain.
  • Need for postoperative ICU hospitalization.
  • Hepatic or renal failure.
  • Patients with a history of taking duloxetine or any SSRIs.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs).
  • Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
  • Quinolones (ciprofloxacin).

Sites / Locations

  • faculty of medicine, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group D (duloxetine group)

Group C (control group)

Arm Description

Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.

Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.

Outcomes

Primary Outcome Measures

Assess the onset of spinal anesthesia
Time to T10 sensory block and time to Bromage 1 motor block

Secondary Outcome Measures

Duration of spinal anesthesia
Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery
Postoperative pain
Will be assessed by the patient using the visual analog scale (VAS, 0=no pain; 10=worst possible pain) every 4hrs up to 24hrs after the operation.
Time for first postoperative rescue analgesia request, frequency, and total morphine consumption
All participants will receive intravenous paracetamol, one gram every 8hrs, VAS score of 4 or more will receive 3 mg morphine intravenously and not be repeated more frequently than 4hrs limited to 12 mg morphine per 24hrs after operation

Full Information

First Posted
September 10, 2021
Last Updated
September 10, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05050656
Brief Title
Oral Duloxetine as a Premedication for Postoperative Pain Control
Official Title
"Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair?" a Prospective, Randomized, Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.
Detailed Description
We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group D (duloxetine group)
Arm Type
Active Comparator
Arm Description
Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.
Arm Title
Group C (control group)
Arm Type
Placebo Comparator
Arm Description
Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.
Intervention Type
Drug
Intervention Name(s)
Duloxetine 60mg
Intervention Description
Duloxetine is a selective SNRI prescribed in depression, anxiety, and chronic pain like diabetic neuropathy and fibromyalgia, it acts through central and peripheral pain modulation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablets identical to duloxetine tablets
Primary Outcome Measure Information:
Title
Assess the onset of spinal anesthesia
Description
Time to T10 sensory block and time to Bromage 1 motor block
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Duration of spinal anesthesia
Description
Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery
Time Frame
4 hours
Title
Postoperative pain
Description
Will be assessed by the patient using the visual analog scale (VAS, 0=no pain; 10=worst possible pain) every 4hrs up to 24hrs after the operation.
Time Frame
24 hours
Title
Time for first postoperative rescue analgesia request, frequency, and total morphine consumption
Description
All participants will receive intravenous paracetamol, one gram every 8hrs, VAS score of 4 or more will receive 3 mg morphine intravenously and not be repeated more frequently than 4hrs limited to 12 mg morphine per 24hrs after operation
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists I or II. Sex: Both sexes. Age between 18 and 50. Height 155-180 cm. Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia. Exclusion Criteria: Declining to give written informed consent. History of allergy to the medications used in the study. Had a history of drug or alcohol abuse. Taking opioids or sedative medications. Inability to communicate with patients to evaluate the postoperative pain. Need for postoperative ICU hospitalization. Hepatic or renal failure. Patients with a history of taking duloxetine or any SSRIs. Contraindications to regional anesthesia (including coagulopathy and local infection). Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs). Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin). Quinolones (ciprofloxacin).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tamer abdelaziz, MD
Organizational Affiliation
Faculty of medicine, Ain Shams University, Cairo, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

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Oral Duloxetine as a Premedication for Postoperative Pain Control

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