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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06341049
Enrollment
120
Registered
2024-04-02
Start date
2024-03-12
Completion date
2025-05-15
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Recovery

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..

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.

Interventions

PROCEDUREIntraperitoneal 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.

PROCEDUREIntrathecal morphine application

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

PROCEDUREQuadratus 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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hoursPostoperative 24th and 48th hoursFor 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026