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

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

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..

Study Overview

• Status: Recruiting
• Conditions: Postoperative Recovery
• Intervention / Treatment: Procedure: Intraperitoneal local anasthetic application + local anesthetic wound infiltration; Procedure: Intrathecal morphine application; Procedure: Quadratus lumborum block tip 1 application

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aysenur Dostbil; Phone Number: +905333676696; Email: adostbil@hotmail.com
• Study Contact Backup: Name: Mehmet Akif Yılmaz; Phone Number: +905346533539; Email: mehmetakifyilmaz025@gmail.com

Study Locations

• Turkey
  • Palandoken
    • Erzurum, Palandoken, Turkey
      • Recruiting
      • Ataturk University
      • Contact: Aysenur Dostbil; Phone Number: +905333676696; Email: adostbil@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Intraperitoneal local anasthetic+ loal 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.	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.
Active Comparator: Group Morphine; Group Morphine will be given 11.2 mg hyperbaric bupivacaine + 15 µg fentanyl + 150 µg morphine into the spinal space.	Procedure: Intrathecal morphine application; Group Morphine will be given 11.2 mg hyperbaric bupivacaine + 15 µg fentanyl + 150 µg morphine into the spinal space.
Active Comparator: Group Quadratus lumborum block; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Study Director: Aysenur Dostbil, Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): June 12, 2024
• Study Completion (Estimated): September 12, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Anesthetics, Local; Morphine
• Other Study ID Numbers: 2024-03/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No