Analgesia
Conditions
Brief summary
This study aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and QLB type I for pain reduction in women undergoing elective cesarean section under spinal anaesthesia.
Detailed description
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 18 to 50 with American Society of Anesthesiologists (ASA) II classification, full-term and singleton pregnancies planned to undergo cesarean section using Pfannenstiel incision with spinal anaesthesia. Using a randomisation procedure, the participants will be allocated into two equal groups: Group IPLA+ LWI and Group QLB.
Interventions
PROCEDUREWound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation
a solution containing 20 ml of 0.5% bupivacaine, 20 ml of 2% lidocaine and 1:200,000 epinephrine with a total volume of 40 ml. A volume of 10 millilitres of the solution will be administered through the drip technique into each of the four quadrants of the uterus prior to the subsequent closure of the parietal peritoneum or fascia. A total volume of 10 ml of the solution will be administered through infiltration at the edges of the rectus aponeurosis, while the remaining 20 ml will be infiltrated subcutaneously into the incision
PROCEDUREGroup QUADRATUS LUMBORUM BLOCK (QLB)
quadratus lumborum type 1 block will be applied bilaterally on both sides with a total of 40 ml of solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200.000 epinephrine, under ultrasound guidance
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* aged between 18 to 50 * American Society of Anesthesiologists (ASA) II classification, * full-term and singleton pregnancies planned to undergo cesarean section * using Pfannenstiel incision * spinal anaesthesia
Exclusion criteria
* whom neuraxial anaesthesia is contraindicated, * those who are allergic to drugs to be used in the study, * who refused to participate in the study, * those with BMI\>35 kg/m2, * ASA score ≥3 or higher, * diabetes mellitus, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain, * individuals who have received opioids during the surgical procedure for intraoperative pain, * patients who have undergone abdominal surgery, * patients who have experienced a transition from spinal anaesthesia to general anaesthesia due to failure, * those with excessive bleeding during the operation, * who have uterine atony, * those who have a drain placed in the area to be infiltrated, * those who cannot understand the Visual Analog Scale (VAS), * who have a history of drug addiction and psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference between total opioid consumption in 24 hours | postoperative 24 hours | The study will involve monitoring the intake of opioids at specific time intervals (2nd, 4th, 6th, 12th, and 24th hours), calculating the cumulative opioid consumption until the 24th hour |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAyşenur Dostbil
Backup ContactAyşenur Dostbil
Outcome results
None listed