Post Caesarean-Section Pain Control Regimens: Oral Regimen With and Without Transversus Abdominis Plane Block
Condition: Reduction in Post Ceasarean-section Related Pain in Study Group (TAP Block)
Study type: Interventional

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 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.

      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.
    


Intervention name(s): TAP block (Bupivacaine 0.25% with epinephrine); Sham block control
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound guided TAP blocks; A blunt needleless syringe was firmly pressed on either side of the abdomen.
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment