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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fentanyl | Drug | Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 24 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous fentanyl consumption | cumulative fentanyl consumption via intravenous patient-controlled analgesia | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jin-Tae Kim | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31519816 | Background | 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. | |
| 31262444 | Background | Patel 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. |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
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| morphine | Drug | Morphine 75 mcg will be injected intrathecally during spinal anesthesia. |
|
|
| Transversus abdominis plane block | Procedure | Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected. |
|
| Sham block | Procedure | Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected. |
|
| 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) | at 6, 12, 18, 48 hours after delivery |
| time to first opioid request | time to first intravenous fentanyl administration from delivery | during hospital stay, an average of 3 days |
| number of patients requiring rescue analgesics | number of patients requiring rescue analgesics | During the first 48 hour-period after delivery |
| Incidence of nausea | Proportion of patients who experienced nausea | During the first 48 hour-period after delivery |
| Incidence of vomiting | Proportion of patients who experienced vomiting | During the first 48 hour-period after delivery |
| Incidence of pruritus | Proportion of patients who experienced pruritus | During the first 48 hour-period after delivery |
| Incidence of sedation | Proportion of patients who experienced sedation | During the first 48 hour-period after delivery |
| Incidence of respiratory depression | Proportion of patients who experienced respiratory depression | 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 | 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 | 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) | During the first 48 hour-period after delivery |
| Hospital length of stay | Hospital length of stay (day) | From admission to hospital discharge, an average of 3 days |
| Apgar Score | Apgar Score of fetus | at 1 minute, at 5 minutes |
| Umbilical arterial pH | Umbilical arterial pH | immediately after delivery |
| Umbilical arterial PO2 | Umbilical arterial PO2 | immediately after delivery |
| Umbilical arterial PCO2 | Umbilical arterial PCO2 | immediately after delivery |
| 30383289 | Background | Kwikiriza 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. |
| 39842942 | Derived | Park 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. |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |