Effect of Three Different Postcesarean Analgesic Techniques on QbsQor-10 Score

NCT06341049 | Completed

• 1 other identifier: 2024-03/14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group Intraperitoneal local anasthetic+ loal anesthetic wound infiltration

ACTIVE COMPARATOR

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

Group Morphine

ACTIVE COMPARATOR

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 Quadratus lumborum block

ACTIVE COMPARATOR

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

Interventions

Intraperitoneal local anasthetic application + local anesthetic wound infiltration PROCEDURE

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.

Group Intraperitoneal local anasthetic+ loal anesthetic wound infiltration

Intrathecal morphine application PROCEDURE

Group Morphine will be given 11.2 mg hyperbaric bupivacaine + 15 µg fentanyl + 150 µg morphine into the spinal space.

Group Morphine

Quadratus lumborum block tip 1 application PROCEDURE

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.

Group Quadratus lumborum block

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Elective cesarean section patients are included in our study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Palandoken, Turkey (Türkiye)

Location

Study Officials

• Aysenur Dostbil

  Ataturk University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 2, 2024
• Study Start: March 12, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 15, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)