Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine 0,75%
- Conditions
- Pain, Postoperative
- Sponsor
- North Karelia Central Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The Demand of Rescue Analgesics (Oxycodone)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Sanna Kouhia
MD
North Karelia Central Hospital
Eligibility Criteria
Inclusion Criteria
- •volunteer
- •age over 18 years
- •spinal anesthesia
- •no allergy to used medications
- •no medications which have effect on pain perception
Exclusion Criteria
- •patient's refusal to participate
- •marked systemic disease
Arms & Interventions
Ropivacaine 0,75%
Postoperative wound infusion 15 mg /h / 48h
Intervention: Ropivacaine 0,75%
NaCl 0,9%
Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
Intervention: NaCl 0,9%
Outcomes
Primary Outcomes
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
- Strength of Pain on Numerical Rating Scale (NRS)(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)(48 hours)