The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery

The purpose of this study was to evaluate the efficacy of dexamethasone when added to epidural bupivacaine on the duration of postoperative analgesia in patients underwent total knee replacement surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

Fifty patients underwent total knee replacement were included in the study. The patients (11 male and 39 female) were classified into two equal groups:- The patients received 15 mL plain bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups was 17 ml.

Postoperative records:

1. Pain score (NRS) at base line, then every 4 hrs for 24 hrs.
2. Frequency of rescue analgesia.
3. Postoperative side effects like nausea, vomiting, and over sedation.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients scheduled for total knee replacement surgery.
2. ASA Physical status I,II,III.

Exclusion Criteria

1. Patients' refusal.
2. Uncooperative patients / Not able to understand pain assessment test.
3. Patients with history of allergy to the used drugs.
4. Significant liver disease.
5. Pregnancy.
6. Any contraindication for epidural anesthesia
7. Failed technique.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: controlled group; Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).	Drug: Dexamethasone; dexamethasone + plain Bupivacaine injected epidurally.; Other Names: Decadrone
Active Comparator: dexamethasone group; Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)	Drug: Dexamethasone; dexamethasone + plain Bupivacaine injected epidurally.; Other Names: Decadrone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of postoperative analgesia (NRS)	first patient request for analgesia or NRS 4 or more	24 hrs postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 17100211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No