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Clinical Trials/NCT06341049
NCT06341049CompletedNot Applicable

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

Ataturk University1 site in 1 country120 target enrollmentStarted: March 12, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts 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

Arms & Interventions

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.

Intervention: Intraperitoneal local anasthetic application + local anesthetic wound infiltration (Procedure)

Group Morphine

Active Comparator

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

Intervention: Intrathecal morphine application (Procedure)

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.

Intervention: Quadratus lumborum block tip 1 application (Procedure)

Outcomes

Primary Outcomes

obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours

Time Frame: Postoperative 24th and 48th 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aysenur Dostbil

Clinical Professor

Ataturk University

Study Sites (1)

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