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

Assiut University

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03231215

17100211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

controlled group

Placebo Comparator group

Description:

Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).

Treatment:

Drug: Dexamethasone

dexamethasone group

Active Comparator group

Description:

Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)

Treatment:

Drug: Dexamethasone