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Reduction in Post Ceasarean-section Related Pain in Study Group (TAP Block)NCT01982929

Post Caesarean-Section Pain Control Regimens: Oral Regimen With and Without Transversus Abdominis Plane Block

A study testing TAP block (Bupivacaine 0.25% with epinephrine) in people with Reduction in Post Ceasarean-section Related Pain in Study Group (TAP Block), run by Vicki Modest, MD at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients at Mbarara Regional Referral Hospital (MRRH) in Uganda who present for routine caesarean sections often go without a set post-operative pain control regimen. Due to lack of established protocols and supplies of essential pain control medications are not reliable, upwards of 90% of women receive no… Read more about this study

Who is it for?
Ages 18 to 44 years, women onlyHealthy volunteers can take part
What is being tested?
TAP block (Bupivacaine 0.25% with epinephrine)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteUganda
Study dates
Nov 2013to Jun 2014
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 18 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women between the age of 18-44;
  • Greater than 50 kilograms in weight;
  • Status post a routine spinal anesthetic without sedation for an uncomplicated caesarean delivery via a low, transverse abdominal incision (Pfannenstiel);
  • In good health with no major medical problems including gastric ulcers, liver or renal dysfunction, and
  • Able to communicate freely with a provided non-family member interpreter fluent in the patient's language so that informed consent may be obtained.

Who cannot join

  • Patients with allergies to bupivicaine, paracetamol, or diclofenac;
  • Patients undergoing a surgical approach is other than a low, transverse abdominal incision (Pfannenstiel);
  • Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;
  • Prior complicated abdominal surgery;
  • Medical history of gastric ulcers, liver or kidney dysfunction; and
  • Patient refusal to be involved in the study. -

Trial locations and contacts

1 site in 1 country.

Uganda1 site
  • Mbarara Regional Referral Hospital, Mbarara, Uganda, Africa

    Mbarara

Other trials in Uganda

About this study

Official title: An Evaluation of Post Caesarean-Section Pain Control Regimens: Non-Opioid Oral Regimen With and Without Transversus Abdominis Plane Block

Patients at Mbarara Regional Referral Hospital (MRRH) in Uganda who present for routine caesarean sections often go without a set post-operative pain control regimen. Due to lack of established protocols and supplies of essential pain control medications are not reliable, upwards of 90% of women receive no postoperative pain control. There are regional techniques that are effective, easy to perform, low risk, and inexpensive. One of these techniques is a tranversus abdominis plane (TAP) block.

A TAP block is a regional anesthesia technique that provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall [1, 3-7]. First described just over a decade ago, it has undergone modifications in technique, and has been shown to be useful in providing 12-24 hours of significant post-operative pain relief for a wide array of surgical procedures [2]. It is best used as the cornerstone of a multi-modal approach to pain control and combines well with oral and intravenous opioid and non-opioid medications.

Read more

This is a technically straightforward procedure that involves injection of local anesthetic within the fascial plane located between the two deepest muscle layers (transversus abdominis and internal oblique muscles) of the lower abdominal wall. Given the simplicity of the TAP block and its long-lasting diminution in post-operative pain after many abdominal and pelvic surgeries, the incorporation of TAP blocks into post- caesarean section pain management should be considered as an achievable and simple remedy to the lack of reliable pain mediations after surgical delivery at MRRH.

This is a study that examines the efficacy of tranversus abdominis plane (TAP) blocks in providing post-operative analgesia after caesarean section under spinal anesthesia at Mbarara Regional Referral Hospital (MRRH) in Uganda, Africa. We will look at the value of TAP blocks in supplementing a routinely used (when available) post-operative non-opioid oral analgesic regimen.

Primary Hypothesis:

The administration of a TAP block on completion of caesarean section will decrease the level of pain as measured by a visual Numerical Rating Score (NRS) at 8, 16 and 24 hours, both at rest and with movement.

Secondary Hypotheses:

  1. The administration of a TAP block on completion of caesarean section will increase the satisfaction score at 8, 16, and 24 hours; and
  2. The administration of a TAP block will decrease or prevent the need for postoperative nurse- administered pethidine (meperidine) as a "rescue" medication.

This is a prospective, randomized, double-blind, sham controlled, single-center trial. A total of 240 patients will be enrolled in the study.

Following completion of the caesarean section, all patient will be screened for enrollment into the study. Enrollees will be randomly assigned to an arm via a predetermined undisclosed random number generator that will not be known by the staff at the MRRH. The anesthesiologist performing the TAP or sham block will be given a sealed envelope with the study arm which the patient has been randomized.

The study procedure is a TAP block and it will be placed on 50% of the enrollees.

TAP BLOCK:

Physicians who have been fully trained on the performance and potential risks of the technique will place TAP blocks under ultrasound-guidance. Briefly, under sterile conditions, ultrasound will be used to identify the targeted abdominal fascial plane. Once located, a predetermined amount of local anesthetic will be injected. This will be performed, bilaterally. The patient will be monitored during the block and for 30 minutes to follow.

SHAM BLOCK:

Sham blocks will consist of a non-invasive ultrasound scan over the abdomen. To mimic the injection of medicine, a dull/blunt object will be gently pressed on either side of the abdomen. The patient will be monitored during the sham block and for 30 minutes to follow.

Being tested
TAP block (Bupivacaine 0.25% with epinephrine), Sham block control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP block (Bupivacaine 0.25% with epinephrine)Procedure or surgery

    Ultrasound guided TAP blocks

  • Sham block controlProcedure or surgery

    A blunt needleless syringe was firmly pressed on either side of the abdomen.

Study groups in NCT01982929
Study groupRoleWhat they receive
Sham block & Oral MedsSham comparatorDefinition intervention. Sham procedure. Blocks mimicked the TAP blocks, but neither needle nor injectate was used. Patients had bilateral ultrasound scans over the lateral aspect of the abdomen. To mimic the injection of medicine, a blunt needleless syringe was firmly pressed on either side of the abdomen. An adhesive bandage was applied over the injection or sham injection sites.
Receives: Procedure: Sham block control
TAP block & Oral MedsExperimentalDefinition intervention. TAP block (Bupivacaine 0.25% with epinephrine 1:400,000 50 cc). TAP blocks were placed using ultrasound-guided identification of the transversus abdominis fascial plane, and in-plane needle guidance. Injection sites were near the Triangle of Petit, located at the lateral edge of the mid-abdomen, near the iliac crests. After negative aspiration for blood, the local anesthetic was injected in 5 cc aliquots. The total dosage injected never exceeded 0.25 mg/kg of 0.25% bupivacaine with epinephrine 1:400,000.
Receives: Procedure: TAP block (Bupivacaine 0.25% with epinephrine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain level at rest, measured using the visual Numerical Rating Score (NRS)

    The NRS is an internationally accepted scale for measuring pain. It is a 0-10 whole interger scale where 0 is no pain and 10 is the worst. This study looks at the change in pain level over a 24 hour period.

    Measured: NRS will be evaluated at T=0, 8, 16, and 24 hours after caesarean section.

  2. Pain level with movement, measured using the visual Numerical Rating Score (NRS)

    The NRS is an internationally accepted scale for measuring pain. It is a 0-10 whole interger scale where 0 is no pain and 10 is the worst. This study looks at the change in pain level over a 24 hour period.

    Measured: NRS will be evaluated at T=0, 8, 16, and 24 hours after caesarean section.

Secondary outcomes (1)
  1. Patient satisfaction with their pain control. The tool is an in person interview,with a yes/no answer

    Measured: 24 hours post caesarean section

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01982929
Sponsor's protocol ID
2013P001906
Status last verified
Sep 2018
First submitted
28 Oct 2013
Last updated
13 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.

    PubMed 22312327

Questions about this trial

What is this clinical trial studying?

A study testing TAP block (Bupivacaine 0.25% with epinephrine) in people with Reduction in Post Ceasarean-section Related Pain in Study Group (TAP Block), run by Vicki Modest, MD at 1 site in Uganda.

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 5 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 13 Sep 2018. 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 Uganda. 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?

Pain level at rest, measured using the visual Numerical Rating Score (NRS) (time frame: NRS will be evaluated at T=0, 8, 16, and 24 hours after caesarean section.). The study lists 2 primary outcomes in all. 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 NCT01982929, which also lists 1 linked publication.

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 13 Sep 2018.

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