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

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06129032

Collaborator

(none)

Enrollment

Location

Arms

19.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation Procedure: Group QUADRATUS LUMBORUM BLOCK (QLB)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Jun 25, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Wound infiltration + Intraperitoneal local anaesthetic instillation 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 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
Active Comparator: Group QUADRATUS LUMBORUM BLOCK 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) 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

Arm

Intervention/Treatment

Active Comparator: Group Wound infiltration + Intraperitoneal local anaesthetic instillation

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

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

Active Comparator: Group QUADRATUS LUMBORUM BLOCK

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)

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atatürk University	Erzurum		Turkey

Sponsors and Collaborators

Ataturk University

Investigators

Study Director: Ayşenur Dostbil, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Aysenur Dostbil, Clinical Professor, Ataturk University

ClinicalTrials.gov Identifier:

NCT06129032

Other Study ID Numbers:

B.30.2.ATA.0.01.00/462

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 14, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Anesthetics, Local

Study Results

No Results Posted as of Nov 14, 2023