Pain, PostoperativeNCT05404490
Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section
A study testing Bupivacain in people with Pain, Postoperative, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 sitePanama
- Study dates
- 1 Jun 2022to 30 Nov 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age ≥ 36 weeks
- Elective cesarean section
- Transverse segmental caesarean section Pfannenstiel type
- Spinal anesthesia
- Maternal age 18 to 45 years
- Any gravaparity
- Patient ASA I or II
Who cannot join
- Any patient who does not meet the inclusion criteria.
- Emergency cesarean section
- History of chronic or neuropathic pain
- Patient with cardiopulmonary disease
- Known allergies to the drugs used in the study
- Patient who does not wish to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section. Randomized, Single Blind, Controlled Trial
This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacain, Placebo
- Keywords
- Cesarean section, Postoperative Pain, Bupivacain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
PlaceboDrug
20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | 20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue. Receives: Drug: Bupivacain |
| Placebo | Placebo comparator | 20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)
Measured: 72 hours
Secondary outcomes (1)
Need for rescue medication
Number of participants that required an additional analgesic for pain control
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404490
- Sponsor's protocol ID
- 2020-575
- Status last verified
- Aug 2025
- First submitted
- 31 May 2022
- Last updated
- 26 Aug 2025
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section. Randomized, Single Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05404490
- Acronym / sponsor ID
- 2020-575
- Conditions
- Pain, Postoperative
- Keywords
- Cesarean section, Postoperative Pain, Bupivacain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 3 Jun 2022 (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 study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: Bupivacain20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue. |
| Placebo | Placebo comparator | Drug: Placebo20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Gestational age ≥ 36 weeks
- Elective cesarean section
- Transverse segmental caesarean section Pfannenstiel type
- Spinal anesthesia
- Maternal age 18 to 45 years
Key exclusion criteria (6 listed)
- Any patient who does not meet the inclusion criteria.
- Emergency cesarean section
- History of chronic or neuropathic pain
- Patient with cardiopulmonary disease
- Known allergies to the drugs used in the study
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 |
|---|---|---|
| Bupivacain20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue. | Drug | Bupivacaine |
| Placebo20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue. | Drug | Placebo |
Primary outcome
Post operative pain
Time frame: 72 hours
Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)
1 secondary outcome
Need for rescue medication
Time frame: 72 hours
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 26 Aug 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacain in people with Pain, Postoperative, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 7 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: finished, as of the sponsor's last update on 26 Aug 2025. 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 Panama. 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. 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?
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?
Post operative pain (time frame: 72 hours). 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 26 Aug 2025.