Cesarean SectionNCT04824274
TAP Block With Intrathecal Fentanyl vs. Intrathecal Morphine in Cesarean Delivery
A study testing fentanyl, morphine and Transversus abdominis plane block in people with Cesarean Section, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- fentanyl, morphine and Transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Apr 2021to 20 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult full-term parturients scheduled to undergo elective cesarean delivery under spinal anesthesia
Who cannot join
- Contraindication to spinal anesthesia
- Any chronic pain unrelated pregnancy
- current opioid medication use
- BMI more than 40 kg m-2
- History of drug allergy or hypersensitivity to fentanyl, morphine, ropivacaine, acetaminophen, NSAIDs, bupivacaine, ramosetron, ondansetron, nalbuphine, Naloxone, metoclopramide
- infection of abdominal wall
Show all 10Show fewer
- Pregnancy-induced hypertension
- known cardiovascular disease
- Known fetal anomaly
- Any sign of onset of labor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane Block With Intrathecal Fentanyl Versus Intrathecal Morphine in Cesarean Delivery: A Randomized, Controlled, Noninferiority Trial
This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia.
Read the detailed description
Healthy mothers scheduled to undergo elective cesarean delivery under spinal anesthesia will be randomly allocated to receive either TAP block plus intrathecal fentanyl (Group TF) or intrathecal morphine (Group M).
Primary outcome is pain score with movement at postoperative 24 hours.
- Conditions
- Cesarean Section
- Keywords
- transversus abdominis plane block, morphine, fentanyl, spinal anesthesia, cesarean section, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.
morphineDrug
Also called Morphine sulfate
Morphine 75 mcg will be injected intrathecally during spinal anesthesia.
Transversus abdominis plane blockProcedure or surgery
Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.
Sham blockProcedure or surgery
Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis plane block and intrathecal fentanyl | Experimental | Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + fentanyl 10 mcg. Following the completion of surgery, ultrasound-guided bilateral transversus abdominis plane block will be done with 0.375% ropivacaine 15 ml per each side. Receives: Drug: fentanyl; Procedure: Transversus abdominis plane block |
| Intrathecal morphine | Active comparator | Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + morphine 75 mcg. Following the completion of surgery, sham block will be done using normal saline. Receives: Drug: morphine; Procedure: Sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score with movement at 24 hours after delivery
Pain score with movement at 24hr after delivery, using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
Measured: at 24 hours after delivery
Secondary outcomes (18)
Intravenous fentanyl consumption
cumulative fentanyl consumption via intravenous patient-controlled analgesia
Measured: at 6, 12, 18, 24, 48 hours after delivery
Pain score at rest
Pain score at rest using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
Measured: at 6, 12, 18, 24, 48 hours after delivery
Pain score with movement
Pain score with movement using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
Measured: at 6, 12, 18, 48 hours after delivery
time to first opioid request
time to first intravenous fentanyl administration from delivery
Measured: during hospital stay, an average of 3 days
number of patients requiring rescue analgesics
number of patients requiring rescue analgesics
Measured: During the first 48 hour-period after delivery
Incidence of nausea
Proportion of patients who experienced nausea
Measured: During the first 48 hour-period after delivery
Incidence of vomiting
Proportion of patients who experienced vomiting
Measured: During the first 48 hour-period after delivery
Incidence of pruritus
Proportion of patients who experienced pruritus
Measured: During the first 48 hour-period after delivery
Incidence of sedation
Proportion of patients who experienced sedation
Measured: During the first 48 hour-period after delivery
Incidence of respiratory depression
Proportion of patients who experienced respiratory depression
Measured: During the first 48 hour-period after delivery
Nausea severity
Nausea severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe
Measured: During the first 48 hour-period after delivery
Pruritus severity
Pruritus severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe
Measured: During the first 48 hour-period after delivery
Patient satisfaction for overall postoperative managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied)
Patient satisfaction score for overall postoperative pain managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied)
Measured: During the first 48 hour-period after delivery
Hospital length of stay
Hospital length of stay (day)
Measured: From admission to hospital discharge, an average of 3 days
Apgar Score
Apgar Score of fetus
Measured: at 1 minute, at 5 minutes
Umbilical arterial pH
Umbilical arterial pH
Measured: immediately after delivery
Umbilical arterial PO2
Umbilical arterial PO2
Measured: immediately after delivery
Umbilical arterial PCO2
Umbilical arterial PCO2
Measured: immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start12 Apr 2021
- Primary completion18 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824274
- Sponsor's protocol ID
- 2012-167-1185
- Status last verified
- Feb 2022
- First submitted
- 19 Mar 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cole J, Hughey S, Longwell J. Transversus abdominis plane block and intrathecal morphine use in cesarean section: a retrospective review. Reg Anesth Pain Med. 2019 Sep 13:rapm-2019-100483. doi: 10.1136/rapm-2019-100483. Online ahead of print.
PubMed 31519816Patel SD, Sharawi N, Sultan P. Local anaesthetic techniques for post-caesarean delivery analgesia. Int J Obstet Anesth. 2019 Nov;40:62-77. doi: 10.1016/j.ijoa.2019.06.002. Epub 2019 Jun 8.
PubMed 31262444Kwikiriza A, Kiwanuka JK, Firth PG, Hoeft MA, Modest VE, Ttendo SS. The analgesic effects of intrathecal morphine in comparison with ultrasound-guided transversus abdominis plane block after caesarean section: a randomised controlled trial at a Ugandan regional referral hospital. Anaesthesia. 2019 Feb;74(2):167-173. doi: 10.1111/anae.14467. Epub 2018 Nov 1.
PubMed 30383289Park SK, Kim Y, Kim H, Kim JT. Transversus abdominis plane block combined with intrathecal fentanyl versus intrathecal morphine for post-cesarean analgesia: a randomized non-inferiority clinical trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):330-336. doi: 10.1136/rapm-2024-106044.
PubMed 39842942
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block With Intrathecal Fentanyl Versus Intrathecal Morphine in Cesarean Delivery: A Randomized, Controlled, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04824274
- Acronym / sponsor ID
- 2012-167-1185
- Conditions
- Cesarean Section
- Keywords
- transversus abdominis plane block, morphine, fentanyl, spinal anesthesia, cesarean section, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 1 Apr 2021 (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.
This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia.
Detailed description
Healthy mothers scheduled to undergo elective cesarean delivery under spinal anesthesia will be randomly allocated to receive either TAP block plus intrathecal fentanyl (Group TF) or intrathecal morphine (Group M).
Primary outcome is pain score with movement at postoperative 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis plane block and intrathecal fentanyl | Experimental | Drug: fentanyl, Procedure: Transversus abdominis plane blockPatients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + fentanyl 10 mcg. Following the completion of surgery, ultrasound-guided bilateral transversus abdominis plane block will be done with 0.375% ropivacaine 15 ml per each side. |
| Intrathecal morphine | Active comparator | Drug: morphine, Procedure: Sham blockPatients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + morphine 75 mcg. Following the completion of surgery, sham block will be done using normal saline. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult full-term parturients scheduled to undergo elective cesarean delivery under spinal anesthesia
Key exclusion criteria (10 listed)
- Contraindication to spinal anesthesia
- Any chronic pain unrelated pregnancy
- current opioid medication use
- BMI more than 40 kg m-2
- History of drug allergy or hypersensitivity to fentanyl, morphine, ropivacaine, acetaminophen, NSAIDs, bupivacaine, ramosetron, ondansetron, nalbuphine, Naloxone, metoclopramide
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 |
|---|---|---|
| fentanylFentanyl 10 mcg will be injected intrathecally during spinal anesthesia. | Drug | Transversus abdominis plane block and intrathecal fentanyl |
| morphineAlso: Morphine sulfateMorphine 75 mcg will be injected intrathecally during spinal anesthesia. | Drug | Intrathecal morphine |
| Transversus abdominis plane blockUltrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected. | Procedure or surgery | Transversus abdominis plane block and intrathecal fentanyl |
| Sham blockUltrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected. | Procedure or surgery | Intrathecal morphine |
Primary outcome
Pain score with movement at 24 hours after delivery
Time frame: at 24 hours after delivery
Pain score with movement at 24hr after delivery, using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
18 secondary outcomes
Intravenous fentanyl consumption
Time frame: at 6, 12, 18, 24, 48 hours after delivery
Pain score at rest
Time frame: at 6, 12, 18, 24, 48 hours after delivery
Pain score with movement
Time frame: at 6, 12, 18, 48 hours after delivery
time to first opioid request
Time frame: during hospital stay, an average of 3 days
number of patients requiring rescue analgesics
Time frame: During the first 48 hour-period after delivery
Incidence of nausea
Time frame: During the first 48 hour-period after delivery
Incidence of vomiting
Time frame: During the first 48 hour-period after delivery
Incidence of pruritus
Time frame: During the first 48 hour-period after delivery
Incidence of sedation
Time frame: During the first 48 hour-period after delivery
Incidence of respiratory depression
Time frame: During the first 48 hour-period after delivery
Nausea severity
Time frame: During the first 48 hour-period after delivery
Pruritus severity
Time frame: During the first 48 hour-period after delivery
Patient satisfaction for overall postoperative managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied)
Time frame: During the first 48 hour-period after delivery
Hospital length of stay
Time frame: From admission to hospital discharge, an average of 3 days
Apgar Score
Time frame: at 1 minute, at 5 minutes
Umbilical arterial pH
Time frame: immediately after delivery
Umbilical arterial PO2
Time frame: immediately after delivery
Umbilical arterial PCO2
Time frame: immediately after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Background: PubMed 31519816Cole J, Hughey S, Longwell J. Transversus abdominis plane block and intrathecal morphine use in cesarean section: a retrospective review. Reg Anesth Pain Med. 2019 Sep 13:rapm-2019-100483. doi: 10.1136/rapm-2019-100483. Online ahead of print.
- Background: PubMed 31262444Patel SD, Sharawi N, Sultan P. Local anaesthetic techniques for post-caesarean delivery analgesia. Int J Obstet Anesth. 2019 Nov;40:62-77. doi: 10.1016/j.ijoa.2019.06.002. Epub 2019 Jun 8.
- Background: PubMed 30383289Kwikiriza A, Kiwanuka JK, Firth PG, Hoeft MA, Modest VE, Ttendo SS. The analgesic effects of intrathecal morphine in comparison with ultrasound-guided transversus abdominis plane block after caesarean section: a randomised controlled trial at a Ugandan regional referral hospital. Anaesthesia. 2019 Feb;74(2):167-173. doi: 10.1111/anae.14467. Epub 2018 Nov 1.
- Derived from this study: PubMed 39842942Park SK, Kim Y, Kim H, Kim JT. Transversus abdominis plane block combined with intrathecal fentanyl versus intrathecal morphine for post-cesarean analgesia: a randomized non-inferiority clinical trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):330-336. doi: 10.1136/rapm-2024-106044.
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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. This study is not recruiting at the moment.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl, morphine and Transversus abdominis plane block in people with Cesarean Section, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score with movement at 24 hours after delivery (time frame: at 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824274, which also lists 4 linked publications.
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 24 Feb 2022.