Evaluation of the Effect of Postoperative Analgesia Techniques With ObsQoR-10

Eskisehir Osmangazi University

Status: Enrolling

Conditions: Postoperative Complications; Pain, Postoperative

Treatments: Other: Group T; Other: Group C; Other: Group W

Study type: Interventional

Funder types: Other

Identifiers

NCT06978491

ESOGU 6

Details and patient eligibility

About

The primary objective of this study is to evaluate the effects of postoperative analgesia techniques-transversus abdominis plane (TAP) block and wound infiltration-on recovery in patients undergoing elective cesarean section, using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. The secondary objective is to assess pain scores, analgesic consumption, and adverse effects such as nausea, vomiting, and pruritus within the first 24 hours postoperatively.

Full description

The patients will be divided into 3 groups as Group T (transversus abdominis plane block), Group W (wound infiltration) and Group K (control). All of them will be given spinal anesthesia in sitting position.Group C will receive spinal anesthesia. In Group T (Transversus abdominis plane block) cases, in addition to spinal anesthesia at the end of the surgery, 20 ml of 0.25% bupivacaine will be applied bilaterally between the transversus abdominis muscle and the internal oblique muscle. Group WI (wound infiltration) will be administered 20 ml 0.25% bupivacaine to the wound area in addition to spinal anesthesia at the end of the surgery.Numerical pain scores (NRS Resting and Movement), heart rate, mean arterial pressure, peripheral oxygen saturation, analgesic consumption, nausea and vomiting score, pruritus, Ramsey sedation scale and other postoperative complications will be recorded at the 2nd hour, 6th hour, 12th hour and 24th hour postoperatively .Obstetric Quality of Recovery -ObsQoR-10 questionnaire will be applied to the patients at the end of 24 hours.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Term obstetric patients aged 18-50 years who underwent elective cesarean section under spinal anesthesia and applied regional anesthesia techniques such as TAP and wound infiltration.

Exclusion criteria

• Refuse to participate in the study
• Patients who have undergone general anesthesia
• Patients requiring emergency cesarean section.
• Mental status disorders
• Known bleeding and/or coagulation disorders
• Infection at injection site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Group C (Control)

Active Comparator group

Description:

spinal anesthesia.

Treatment:

Other: Group C

Group T (Transversus Abdominis Plane Block)

Active Comparator group

Description:

The operation will be performed under spinal anesthesia and at the end of the operation, 20 ml of 0.25% bupivacaine will be applied bilaterally between the transverse abdominis muscle and the internal oblique muscle.

Treatment:

Other: Group T

Group W (Wound Infıltration)

Active Comparator group

Description:

The operation will be performed under spinal anesthesia and at the end of the operation, 20 ml of 0.25% bupivacaine will be applied wound infiltration

Treatment:

Other: Group W