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Phase 4 N=67 Randomized Quadruple-blind Treatment

Infiltration Analgesia After Caesarean Section

Pain, Postoperative · Caesarean Section

Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: The Demand of Rescue Analgesics (Oxycodone) — 47.5; 57.8 mg — p=0.10

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ropivacaine 0,75% (Drug); NaCl 0,9% (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
North Karelia Central Hospital
Primary completion
Oct 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
The Demand of Rescue Analgesics (Oxycodone)
47.5; 57.8 0.10
SECONDARY
Strength of Pain on Numerical Rating Scale (NRS)
5; 6; 3; 3.75; 3; 3 0.08
SECONDARY
Postoperative Nausea and Vomiting (PONV)
7; 11 0.30

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01094106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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