Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

Ufuk University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Levobupivacaine; Drug: Tramadol infusion via wound catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01916915

09/06

Details and patient eligibility

About

Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections.

Enrollment: 65 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned cesarean section
• American Society of Anesthesiologists Class I-II

Exclusion criteria

• Patients refusing to enroll in the study
• Serious coagulopathy
• Serious systemic disease
• Story of allergy to drugs being used in the study
• Morbid obesity (Body mass index > 30)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 3 patient groups, including a placebo group

Tramadol 1

Experimental group

Description:

1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion

Treatment:

Drug: Levobupivacaine

Drug: Tramadol infusion via wound catheter

Tramadol 2

Experimental group

Description:

2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion

Treatment:

Drug: Levobupivacaine

Drug: Tramadol infusion via wound catheter

Levobupivacaine

Placebo Comparator group

Description:

0.25% levobupivacaine 4ml/h infusion

Treatment:

Drug: Levobupivacaine