Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section

Saint Thomas Hospital (HST)

Status: Completed

Conditions: Pain, Postoperative

Treatments: Drug: Bupivacain; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05404490

2020-575

Details and patient eligibility

About

This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.

Enrollment: 202 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age ≥ 36 weeks
• Elective cesarean section
• Transverse segmental caesarean section Pfannenstiel type
• Spinal anesthesia
• Maternal age 18 to 45 years
• Any gravaparity
• Patient ASA I or II

Exclusion criteria

• Any patient who does not meet the inclusion criteria.
• Emergency cesarean section
• History of chronic or neuropathic pain
• Patient with cardiopulmonary disease
• Known allergies to the drugs used in the study
• Patient who does not wish to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups, including a placebo group

Bupivacaine

Experimental group

Description:

20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.

Treatment:

Drug: Bupivacain

Placebo

Placebo Comparator group

Description:

20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.

Treatment:

Drug: Placebo