PainNCT07900997
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
A study testing Postoperative Analgesia Protocol in people with Pain and Postoperative Pain, run by Konya City Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative Pain
- What is being tested?
- Postoperative Analgesia Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Pain, Postoperative Pain
- Being tested
- Postoperative Analgesia Protocol
- Keywords
- postoperative analgesia, quality of recovery-10, cesarean
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Analgesia ProtocolOther
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).
| Study group | Role | What they receive |
|---|---|---|
| sacral erector spinae plane block | Active comparator | 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). Receives: Other: Postoperative Analgesia Protocol |
| Multiple modal analgesia | Sham comparator | 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. Receives: Other: Postoperative Analgesia Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra GÖGER, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900997
- Sponsor's protocol ID
- Effect of Sacral Erector Spina
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07900997
- Acronym / sponsor ID
- Effect of Sacral Erector Spina
- Conditions
- Pain, Postoperative Pain
- Keywords
- postoperative analgesia, quality of recovery-10, cesarean
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sacral erector spinae plane block | Active comparator | Other: Postoperative Analgesia ProtocolThe 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). |
| Multiple modal analgesia | Sham comparator | Other: Postoperative Analgesia ProtocolAfter 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Refusal to provide informed consent.
- Contraindication to regional anesthesia.
- Abnormal coagulation profile.
- Infection at the proposed block site.
- Emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative Analgesia ProtocolThe 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 | Multiple modal analgesia, sacral erector spinae plane block |
Primary outcome
quality of recovery-10
Time frame: one day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Analgesia Protocol in people with Pain and Postoperative Pain, run by Konya City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of recovery-10 (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.