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

NCT06129032 | Unknown

• 1 other identifier: B.30.2.ATA.0.01.00/462
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group Wound infiltration + Intraperitoneal local anaesthetic instillation

ACTIVE COMPARATOR

the surgeon will be given 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. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours.

Procedure: Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation

Group QUADRATUS LUMBORUM BLOCK

ACTIVE COMPARATOR

In the QLB group, 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. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours.

Procedure: Group QUADRATUS LUMBORUM BLOCK (QLB)

Interventions

Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation PROCEDURE

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 Wound infiltration + Intraperitoneal local anaesthetic instillation

Group QUADRATUS LUMBORUM BLOCK (QLB) PROCEDURE

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

Group QUADRATUS LUMBORUM BLOCK

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 26996986 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşenur Dostbil

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

Ayşenur Dostbil

CONTACT

+905333677796; adostbil@hotmail.com

Ayşenur Dostbil

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 25, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

TU (1)