Clinical trial NCT06129032: Comparing QLB Type I Block to Intraperitoneal Instillation Added to Wound Infiltration for Postoperative Cesarian Pain
Official title: Comparing Quadratus Lumborum Type 1 Block to The Combination Of Intraperitoneal Instillation Of Local Anesthetics And Wound Infiltration For Postoperative Pain After Cesarean Delivery: A Prospective Double-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: difference between total opioid consumption in 24 hours
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
affiliation: Ataturk University
name: Ayşenur Dostbil
role: STUDY_DIRECTOR
References:
citation: Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
citation: Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.