[Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]

Abstract

Objectives: The efficacy of single-dose intraincisional infiltration with levobupivacaine in postoperative analgesia and chronic pain after caesarean sections is unknown.

Study: A placebo-controlled double-blind randomized trial.

Patients and methods: After ethical approval, and written inform consent, 140 women scheduled for a caesarean section were randomly assigned and received 30mL of levobupivacaine 0.5% (L group) or saline (placebo-P group) into their wound. The primary endpoint was morphine consumption (using intravenous morphine patient-controlled analgesia) for the first 24h after surgery. At 1h to 48h, side effects, pain at rest and pain 2months later were recorded.

Results: All included patients had similar demographic and surgical characteristics. The morphine consumption was significantly lower in the L group at h6, h8 and h12 (considering both total intake and each request). At h4, the mean total morphine consumption was 25 (12) mg in the L group versus 31 (14) mg in the P group (P=0.05). Time until discharge and side effects including nausea-vomiting (14 vs 20%), wound scar complications (6 vs 8%) and chronic pain after 2months (25% in both groups complained of small pain, and 75% no pain) were similar between the two groups (P>0.05).

Conclusion: Single-dose local infiltration of levobupivacaine 0.5% reduced opioid requirement at 12h, with no difference after 24h. www.clinicaltrials.com, number: NCT00621907.