Infiltration Analgesia After Caesarean Section

North Karelia Central Hospital70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative Caesarean Section

Interventions

Ropivacaine 0,75%DRUG

Postoperative wound infusion 2 ml/ h/ 48h

NaCl 0,9%DRUG

Postoperative wound infusion 2 ml/h/48h

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

North Karelia Central hospital

Joensuu, Finland

Outcomes

Primary Outcomes

The Demand of Rescue Analgesics (Oxycodone)

The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.

Time frame: 48 hours

Secondary Outcomes

Strength of Pain on Numerical Rating Scale (NRS)

Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.

Time frame: 48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)

Postoperative Nausea and Vomiting (PONV)

The numbers of patients with at least mild nausea at any time post-operatively.

Time frame: 48 hours

Data from ClinicalTrials.gov

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