The Analgesic Efficacy of Wound Infiltration With Tramadol

Yeditepe University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT02518438

190

Details and patient eligibility

About

This double-blind, randomized trial examined whether tramadol wound infiltration decreased postoperative pain following cesarean delivery under general anesthesia or reduced the need for analgesics in the immediate postoperative period. Patients in the tramadol group consumed significantly less morphine at all time intervals than those in the control group. The investigators suggest that the use of wound infiltration with tramadol may be a useful technique in patients who undergo cesarean section under general anesthesia to reduce postoperative pain, improve recovery, and facilitate early contact of mothers with their babies.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nulliparity
• Gestation age between 37-40 weeks
• CS under general anesthesia

Exclusion criteria

• Pre-eclampsia
• Cardiovascular problems
• Allergy to any of the study medications
• Chronic preoperative pain
• Regular analgesic use

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

the tramadol group

Active Comparator group

Description:

A preprepared 20 ml solution (tramadol 2 mgkg-1 within a 0.9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.

Treatment:

Drug: Tramadol

the placebo group

Placebo Comparator group

Description:

A preprepared 20 ml solution (0,9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.