ClinicalTrials.gg
Not yet recruitingNCT07900997Updated Oct 28, 2026

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

An interventional study of Postoperative Analgesia Protocol in Pain and Postoperative Pain, sponsored by Konya City Hospital. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.

Primary conditionPain, PostoperativeRegistry: PainReclassifiedWhy we changed it
Registry
Pain — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pain, Postoperative
Why
  1. The study's listed conditions name Pain, Postoperative, a narrower term within Pain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Konya City Hospital · Not applicable, Interventional, and Other

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Pain
  • Postoperative Pain

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Keywords

  • postoperative analgesia
  • quality of recovery-10
  • cesarean
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In context

Pain, Postoperative Reclassified

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Konya City Hospital is the lead sponsor of 81 studies on the registry; 23 are open to participants now.

Compared within Pain, Postoperative, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18-45 years
  • (ASA) physical status I-III who can provide and are scheduled for elective cesarean delivery under spinal anesthesia will be eligible for inclusion.

Exclusion criteria

Exclusion Criteria:

  • Refusal to provide .
  • to regional anesthesia.
  • Abnormal coagulation profile.
  • Infection at the proposed block site.
  • Emergency surgery.
  • Allergy to any of the study medications.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    sacral erector spinae plane block

    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).

    Other: Postoperative Analgesia Protocol

  • Sham comparator
    Multiple modal analgesia

    After surgery under spinal anesthesia has been completed, patients will undergo the sham block procedure in the PACU. They will also receive intravenous paracetamol, 1 g three times daily, and 50 mg dexketoprofen as rescue analgesia when the NRS score is ≥3.

    Other: Postoperative Analgesia Protocol

Interventions

  • OtherPostoperative Analgesia Protocol

    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).

06

What researchers measure

Primary outcomes

  1. quality of recovery-10

    The 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.

    Time frame: one day

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07900997
Lead sponsor
Konya City Hospital
Responsible party
Esra GÖGER (SPECİALİST M.D., Konya City Hospital) — Principal investigator
First posted
Oct 28, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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