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

 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.
Inclusion Criteria:

 1. Women between the age of 18-44;

 2. Greater than 50 kilograms in weight;

 3. Status post a routine spinal anesthetic without sedation for an uncomplicated
 caesarean delivery via a low, transverse abdominal incision (Pfannenstiel);

 4. In good health with no major medical problems including gastric ulcers, liver or renal
 dysfunction, and

 5. Able to communicate freely with a provided non-family member interpreter fluent in the
 patient's language so that informed consent may be obtained.

 Exclusion Criteria:

 1. Patients with allergies to bupivicaine, paracetamol, or diclofenac;

 2. Patients undergoing a surgical approach is other than a low, transverse abdominal
 incision (Pfannenstiel);

 3. Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;

 4. Prior complicated abdominal surgery;

 5. Medical history of gastric ulcers, liver or kidney dysfunction; and

 6. Patient refusal to be involved in the study. -