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Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial

Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07900997
Enrollment
80
Registered
2026-10-28
Start date
2026-11-01
Completion date
2027-05-01
Last updated
2026-10-28

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

Conditions

Pain, Postoperative Pain

Keywords

postoperative analgesia, quality of recovery-10, cesarean

Brief summary

Cesarean delivery is one of the most frequently performed major surgical procedures worldwide. The postcesarean period is characterized by moderate to severe pain, which may adversely affect postoperative recovery, patient satisfaction, breastfeeding success, and maternal-infant bonding. Current guidelines recommend a multimodal approach to postcesarean analgesia that reduces opioid consumption and minimizes adverse effects. The Procedure-Specific Postoperative Pain Management working group recommends multimodal protocols for elective cesarean delivery that combine systemic analgesics (regular paracetamol and nonsteroidal anti-inflammatory drugs, neuraxial intrathecal morphine, and/or abdominal wall blocks, such as transversus abdominis plane and quadratus lumborum blocks.

Detailed description

Cesarean delivery is one of the most frequently performed major surgical procedures worldwide. The postcesarean period is characterized by moderate to severe pain, which may adversely affect postoperative recovery, patient satisfaction, breastfeeding success, and maternal-infant bonding. Current guidelines recommend a multimodal approach to postcesarean analgesia that reduces opioid consumption and minimizes adverse effects. The Procedure-Specific Postoperative Pain Management working group recommends multimodal protocols for elective cesarean delivery that combine systemic analgesics (regular paracetamol and nonsteroidal anti-inflammatory drugs, neuraxial intrathecal morphine, and/or abdominal wall blocks, such as transversus abdominis plane and quadratus lumborum blocks. Although erector spinae plane block is performed at thoracic and lumbar levels, the more recently described sacral erector spine plane block is a relatively novel technique involving injection into the plane between the multifidus muscle and the sacrum. It targets the sacral dermatomes, including the pudendal nerve distribution. Sacral erector spine plane block was first described in 2019 for pilonidal sinus surgery and subsequently for abdominal surgery.

Interventions

The ESP block will be performed bilaterally, with 20 mL of local anesthetic solution injected on each side between the multifidus muscle and the median sacral crest. For each side, the solution will be prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of 0.9% sodium chloride, yielding a final bupivacaine concentration of 0.25% (50 mg per side; 100 mg in total).

Sponsors

Konya City Hospital
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients aged 18-45 years * American Society of Anesthesiologists (ASA) physical status I-III who can provide informed consent and are scheduled for elective cesarean delivery under spinal anesthesia will be eligible for inclusion.

Exclusion criteria

* Refusal to provide informed consent. * Contraindication to regional anesthesia. * Abnormal coagulation profile. * Infection at the proposed block site. * Emergency surgery. * Allergy to any of the study medications.

Design outcomes

Primary

MeasureTime frameDescription
quality of recovery-10one dayThe primary outcome will be assessed using the Obstetric Quality of Recovery-10-Turkish (ObsQoR-10T) scale, whose Turkish validity and reliability were established by Kozanhan et al. The scale assesses 10 domains: pain, nausea and vomiting, dizziness, shivering, comfort, independent mobilization, personal hygiene, feeding/breastfeeding the baby without assistance, holding the baby without assistance, and a sense of control. Each item is scored from 0 to 10. The first four items, which assess adverse symptoms, are reverse-scored before calculating the total score. The total score ranges from 0 to 100, with higher scores indicating better postpartum quality of recovery. The scale will be administered at 24 hours postoperatively.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 29, 2026