Cesarean Section ComplicationsNCT06324942
Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section.
A study testing Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg in people with Cesarean Section Complications and Pain, Postoperative, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Pain, Postoperative
- What is being tested?
- Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2025to Dec 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA status II to III
- All patients undergoing elective CS under regional anesthesia at any gestational age.
Who cannot join
- - Known drug allergy to local anesthetics
- Planned general anesthetic
- NSAID use contraindicated post partum
- Chronic pain disorder or chronic narcotic use/dependence
- Planned vertical abdominal incision
- Planned Cesarean Hysterectomy.
- Placenta Previa or suspected Placenta Accreta
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 2T9
Stephen Wood, MD, 403-944-1438, stephen.wood@albertahealthservices.ca
About this study
The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.
Read the detailed description
Randomized clinical trial of Transversus Abdominis Plane Block (TAP block) at Cesarean Section.
- Being tested
- Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kgOther
Also called TAP block
Surgeon-administered Transversus Abdominis Plane Block
| Study group | Role | What they receive |
|---|---|---|
| Surgeon-administered Transversus Abdominis Plane Block (TAP block) | Experimental | After uterine closure, the anterior abdominal wall on the contralateral side to the surgeon is elevated and retracted laterally by an assistant. The bowel and uterus is retracted using the surgeon's non-dominant hand, with or without a sponge. Under direct visualization, a blunted spinal needle is inserted lateral to the rectus muscle to avoid injury to inferior epigastric blood vessels. The needle is then gently advanced through the transversus abdominis fascia into the TAP plane, identified at loss of resistance, or 'a pop'. After aspiration to confirm no accidental placement of the needle intravascularly, local anaesthetic is infiltrated into the transverse abdominis plane through the parietal peritoneum by the surgeon at a prespecified dose of 0.25% bupivicaine 0.25 mL/kg (approximately 20cc). This is repeated on the contralateral side, after which closure of the fascia, subcutaneous tissue, and skin were performed. Receives: Other: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg |
| No TAP block | No intervention | A sham procedure will not be performed but the patient will be unaware of whether or not an injection was done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
VAS scale 0-no pain to 10-worst pain
Measured: 12 hours post op
Secondary outcomes (3)
Time to first request for rescue analgesia in hours
Time from completion of surgery to first request for rescue analgesia in hours
Measured: 48 hours post op
Post operative Opioid use
Total opioid consumption in the first 24h and 48h mark, postoperatively
Measured: up to 48 hours post op.
Time from surgery to discharge from hospital
Time from completion of surgery to discharge
Measured: Up to discharge from hospital, usually 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start19 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wood, University of Calgary
- Investigators
- Stephen Wood, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324942
- Sponsor's protocol ID
- REB24-0349
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2024
- Last updated
- 15 Jun 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section.
- ClinicalTrials.gov ID
- NCT06324942
- Acronym / sponsor ID
- REB24-0349
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Mar 2024 (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.
The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.
Detailed description
Randomized clinical trial of Transversus Abdominis Plane Block (TAP block) at Cesarean Section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon-administered Transversus Abdominis Plane Block (TAP block) | Experimental | Other: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kgAfter uterine closure, the anterior abdominal wall on the contralateral side to the surgeon is elevated and retracted laterally by an assistant. The bowel and uterus is retracted using the surgeon's non-dominant hand, with or without a sponge. Under direct visualization, a blunted spinal needle is inserted lateral to the rectus muscle to avoid injury to inferior epigastric blood vessels. The needle is then gently advanced through the transversus abdominis fascia into the TAP plane, identified at loss of resistance, or 'a pop'. After aspiration to confirm no accidental placement of the needle intravascularly, local anaesthetic is infiltrated into the transverse abdominis plane through the parietal peritoneum by the surgeon at a prespecified dose of 0.25% bupivicaine 0.25 mL/kg (approximately 20cc). This is repeated on the contralateral side, after which closure of the fascia, subcutaneous tissue, and skin were performed. |
| No TAP block | No intervention | –A sham procedure will not be performed but the patient will be unaware of whether or not an injection was done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA status II to III
- All patients undergoing elective CS under regional anesthesia at any gestational age.
Key exclusion criteria (7 listed)
- - Known drug allergy to local anesthetics
- Planned general anesthetic
- NSAID use contraindicated post partum
- Chronic pain disorder or chronic narcotic use/dependence
- Planned vertical abdominal incision
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 |
|---|---|---|
| Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kgAlso: TAP blockSurgeon-administered Transversus Abdominis Plane Block | Other | Surgeon-administered Transversus Abdominis Plane Block (TAP block) |
Primary outcome
Post operative Pain
Time frame: 12 hours post op
VAS scale 0-no pain to 10-worst pain
3 secondary outcomes
Time to first request for rescue analgesia in hours
Time frame: 48 hours post op
Post operative Opioid use
Time frame: up to 48 hours post op.
Time from surgery to discharge from hospital
Time frame: Up to discharge from hospital, usually 1-3 days
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 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Stephen Wood, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg in people with Cesarean Section Complications and Pain, Postoperative, run by University of Calgary at 1 site in Canada.
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 7 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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 Canada. 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?
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?
Contact Stephen Wood, MD (4039441438, slwood@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative Pain (time frame: 12 hours post op). 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 15 Jun 2026.