Oral Duloxetine as a Premedication for Postoperative Pain Control

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05050656

Collaborator

(none)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

15.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Duloxetine 60mg Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

Mar 15, 2021

Actual Primary Completion Date :

Jul 28, 2021

Actual Study Completion Date :

Jul 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group D (duloxetine group) Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.	Drug: Duloxetine 60mg 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
Placebo Comparator: Group C (control group) Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.	Drug: Placebo placebo tablets identical to duloxetine tablets

Arm

Intervention/Treatment

Active Comparator: Group D (duloxetine group)

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

Drug: Duloxetine 60mg

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

Placebo Comparator: Group C (control group)

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

Drug: Placebo

placebo tablets identical to duloxetine tablets

Outcome Measures

Primary Outcome Measures

Assess the onset of spinal anesthesia [20 min]
Time to T10 sensory block and time to Bromage 1 motor block

Secondary Outcome Measures

Duration of spinal anesthesia [4 hours]
Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery
Postoperative pain [24 hours]
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 [24 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine, Ain Shams University	Cairo		Egypt	11591

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: tamer abdelaziz, MD, Faculty of medicine, Ain Shams University, Cairo, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamer Samir Abdelsalam, Lecturer of Anesthesia, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05050656

Other Study ID Numbers:

FMASU R 63/ 2021

First Posted:

Sep 20, 2021

Last Update Posted:

Sep 20, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Duloxetine Hydrochloride

Study Results

No Results Posted as of Sep 20, 2021