Infiltration Analgesia After Caesarean Section

North Karelia Central Hospital

Status and phase: Completed; Phase 4

Conditions: Caesarean Section; Pain, Postoperative

Treatments: Drug: Ropivacaine 0,75%; Drug: NaCl 0,9%

Study type: Interventional

Funder types: Other

Identifiers

NCT01094106

NCCHAne001

Details and patient eligibility

About

Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.

According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.

The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• volunteer
• age over 18 years
• spinal anesthesia
• ASA 1-2
• no allergy to used medications
• no medications which have effect on pain perception

Exclusion criteria

• patient's refusal to participate
• marked systemic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Ropivacaine 0,75%

Active Comparator group

Description:

Postoperative wound infusion 15 mg /h / 48h

Treatment:

Drug: Ropivacaine 0,75%

NaCl 0,9%

Placebo Comparator group

Description:

Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h

Treatment:

Drug: NaCl 0,9%