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NCT Number: NCT01094106

Infiltration Analgesia After Caesarean Section

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.

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Key information

Conditions

Pain, Postoperative Caesarean Section Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

North Karelia Central hospital

Joensuu, 80880, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaine 0,75%

Drug

Postoperative wound infusion 2 ml/ h/ 48h

NaCl 0,9%

Drug

Postoperative wound infusion 2 ml/h/48h

Primary outcomes

  1. The Demand of Rescue Analgesics (Oxycodone)

    Time frame: 48 hours

    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.

Secondary outcomes

  1. Strength of Pain on Numerical Rating Scale (NRS)

    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)

    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.

  2. Postoperative Nausea and Vomiting (PONV)

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

North Karelia Central Hospital

Other

Registry information

Official study title

Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2010
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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