Comparing QLB Type I Block to Intraperitoneal Instillation Added to Wound Infiltration for Postoperative Cesarian Pain

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129032
• Other study ID #: B.30.2.ATA.0.01.00/462
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 25, 2025

Study information

• Verified date: November 2023
• Source: Ataturk University
• Contact: Aysenur Dostbil
• Phone: +905333677796
• Email: adostbil[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 25, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Wound 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
• Group 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

Locations

Country	Name	City	State
Turkey	Atatürk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference between total opioid consumption in 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	postoperative 24 hours