Comparison of the Application of Lidocaine With Intraperitoneal Bupivacaine in Cesarian Operations Wound Infiltration

NCT04856735 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-04-23

No results posted yet for this study

Summary

Postoperative pain control is important to reduce morbidity and mortality, and this becomes even more important after cesarean delivery. Severe postpartum pain is associated with chronic pain, and the mother faces a 2.5-fold increased risk of chronic pain and a 3-fold increased risk of postpartum depression compared to mild ones Postoperative pain management is more difficult in the postpartum period. Because the main analgesics used are opioids that are excreted from milk and the newborn may be exposed to the side effects of these drugs . Therefore, multimodal approach is recommended in pain management.

Surgical wound infiltration (LWI) of local anesthetics is an important component of multimodal analgesia . Some of the pain from surgery is caused by an inflammatory response to the surgical incision; therefore, reducing this inflammation can provide a better analgesia and also minimize side effects .

Ease of use and safety of intraperitoneal local anesthetics (IPLA) has been demonstrated in studies and has become a useful alternative to opioid-based analgesic regimens for the treatment of acute postoperative pain.

Investigators aim is to compare the effectiveness of LWI and IPLA applications on postoperative analgesia in women undergoing elective cesarean delivery under spinal anesthesia (SA).

Investigators hypothesis, H0, was that there was no statistically significant difference between the three groups in the mean postoperative pain scores at the 24th hour during movement.

H1 was a statistically significant difference between the mean postoperative pain scores at the 24th hour during the movement between the three groups.

The primary aim of the study was pain scores during the postoperative 24th hour mobilization.

Secondary outcome was total fentanyl consumption (µg) in the first postoperative 24 hours

Conditions

  • Postoperative Pain
  • Cesarean Section

Interventions

OTHER

Intraperİtoneal local anaesthesİc İn cesarean sectİon

After the birth of the newborn and placenta, the uterus is closed and the blood accumulated in the pelvis is carefully wiped with surgical towels, after hemostasis is fully achieved, a total of 20 ml solution containing 10 cc of 0.5% bupivacaine +10 cc 2% lidocaine and 2 injectors containing 20ml saline and the 20ml solution were given to the surgeon area.

OTHER

Local wound infiltrasyon

A solution containing 20 ml of saline was added to all four quadrants of the uterus in 5 ml volume and 20 ml solution containing lidocaine and bupivacaine were subcutaneously in the form of LWI before the skin was closed

OTHER

Control group

One of the two sterile injectors containing 20 ml of saline was applied to the uterine peritoneal region and the other was applied to the incision area as a local subcutaneous wound infiltration.

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Principal Investigators

  • AYŞENUR DOSTBİL, MD · Ataturk University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856735 on ClinicalTrials.gov