ClinicalTrials.gg
CompletedNCT05404490Updated Aug 26, 2025

Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section

An interventional study of Bupivacain and Placebo in Pain, Postoperative, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • Cesarean section
  • Postoperative Pain
  • Bupivacain
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 202 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Saint Thomas Hospital, Panama is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age ≥ 36 weeks
  • Elective cesarean section
  • Transverse segmental caesarean section Pfannenstiel type
  • Spinal anesthesia
  • Maternal age 18 to 45 years
  • Any gravaparity
  • Patient

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
202 participants (actual)

Study arms

  • Experimental
    Bupivacaine

    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.

    Drug: Bupivacain

  • Placebo comparator
    Placebo

    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.

    Drug: Placebo

Interventions

  • 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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Post operative pain

    Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)

    Time frame: 72 hours

Secondary outcomes

  1. Need for rescue medication

    Number of participants that required an additional analgesic for pain control

    Time frame: 72 hours

07

Study locations

1 site
  • Saint Thomas H
    Panama City, Provincia de Panamá, Panama
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Oct 2022, 4 months.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 4 months is below that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2022
First posted
Jun 3, 2022
StartActual
Jun 1, 2022
Primary completionActual
Oct 31, 2022
CompletionActual
Nov 30, 2022
Last update
Aug 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05404490
Lead sponsor
Saint Thomas Hospital, Panama
Responsible party
Osvaldo A. Reyes T. (Chair of the Research Department, Saint Thomas Hospital, Panama) — Principal investigator
First posted
Jun 3, 2022
Start date
Jun 1, 2022
Primary completion
Oct 31, 2022
Completion
Nov 30, 2022
Last update
Aug 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Bupivacaine

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