Effect of Three Different Postcesarean Analgesic Techniques on QbsQor-10 Score: Prospective, Randomized Trial

Postoperative Recovery Clinical Trial

Official title:

Effect of Three Different Postcesarean Analgesic Techniques on ObsQoR-10 Score: Prospective, Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341049
• Other study ID #: 2024-03/14
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: September 12, 2025

Study information

• Verified date: March 2024
• Source: Ataturk University
• Contact: Aysenur Dostbil
• Phone: +905333676696
• Email: adostbil[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effects of three different postsesarean analgesia techniques, including instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block, on the postoperative recovery of women using the ObsQoR-10 score..

Description:

This study will be planned on women who will undergo elective cesarean section surgery with neuraxial anesthesia, after obtaining ethics committee approval and written informed consent from the patients.Parturients will be randomized by the statistician using a computerized random numbers table and divided into 3 equal groups: Group IPLA + LWI, Group QLB 1 and Group M.Postoperatively, patients' ObsQoR-10 scores will be evaluated and recorded at the 24th and 48th hours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 12, 2025
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Elective cesarean section under spinal anesthesia
• Full-term singleton pregnancy
• Agree to participate in the study
• American Society of Anaesthesiology Score of II

Exclusion Criteria:

• Contrindication for neuraxial anesthesia
• ASA=3, diabetes, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain
• Age< 18 or > 50
• Multiple pregnancy
• Presence of psychiatric diseases
• Gave a history of allergic to any medication in the study protocol
• Gave a history of chronic pain
• Unable to consent
• BMI>35 kg/m2
• Those who were given opioids during the operation due to intraoperative pain
• Those who have had previous abdominal surgery
• Patients who failed spinal anesthesia and switched to general anesthesia
• Those who have excessive bleeding or uterine atony during the operation
• Does not understand VAS
• Those who have a drain placed in the area to be infiltrated
• Gave a history of drug addiction

Related Conditions & MeSH terms

• Postoperative Recovery

Intervention

Procedure:
• Intraperitoneal local anasthetic application + local anesthetic wound infiltration
For Group Intraperitoneal local anasthetic+ loal anesthetic wound infiltration, after the birth of the newborn and placenta, the uterus is taken out and closed, the blood accumulated in the pelvis is carefully wiped with surgical towels, and after complete hemostasis is achieved, sterilely prepared 20 ml 0.5% bupivacaine + 20 ml 2% lidocaine +1 A total of 40 ml of solution containing 200,000 epinephrine will be given to the surgeon. 10 ml of this solution will be instilled into all four quadrants of the uterus before closing the parietal peritoneum or fascia. The parietal peritoneal layer will be sutured or left open, depending on the surgeon's preference. 10 ml will be infiltrated around the edges of the rectus aponeurosis, and the remaining 20 ml will be infiltrated subcutaneously into the wound area.
• Intrathecal morphine application
Group Morphine will be given 11.2 mg hyperbaric bupivacaine + 15 µg fentanyl + 150 µg morphine into the spinal space.
• Quadratus lumborum block tip 1 application
In Group Quadratus lumborum block, Quadratus lumborum block type I, a total of 40 ml of a solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200,000 epinephrine will be applied bilaterally under ultrasound guidance.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum	Palandoken

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours	For post-cesarean analgesia, patients will receive instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block. ObsQoR-10 scores of the patients will be evaluated at the 24th and 48th hours postoperatively.	Postoperative 24th and 48th hours