Clinical trial NCT03263689: Transversus Abdominis Plane Block Versus Spinal Morphine After Caesarean Section : A Comparison Study
Official title: The Analgesic Effects of Intrathecal Morphine in Comparison to Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section: a Randomized Controlled Trial at a Ugandan Regional Referral Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy, Ceasarian Section, Anaesthesia
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients in the intrathecal morphine (ITM group) were given a sham block, while the patients in the TAP group were given a TAP block. Sham blocks consisted of a non-invasive ultrasound scan. A blunt needle was gently pressed on either side of the abdomen. Bilateral TAP blocks were placed after ultrasound location of the transversus abdominis and internal oblique muscles, with the injection sites in the Triangle of Petit located at the lateral edge of the mid-abdomen. Following negative aspiration for blood, the local anaesthetic (0.25% bupivacaine with 1:200000 epinephrine) was injected in the transversus abdominis plane under ultrasound visualization in 5 cc aliquots for a total volume of 15cc per side.
Primary purpose: TREATMENT

Brief summary: Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.

Detailed description: Intrathecal morphine (ITM), administered as a part of spinal anesthesia for caesarian section, can produce significant post-operative analgesia for several hours. The Tranversus Abdominis Plane (TAP) Block can also provide prolonged post-operative pain control. A small number of published studies comparing analgesic outcomes after cesarian section with ITM or TAP block have reported variable results.Moreover, these studies have been conducted in countries with extensive post-operative nursing care.

Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.

Eligibility criteria: Inclusion Criteria:

1. Women between the age of 18-45;
2. Greater than 50 kilograms in weight;
3. 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
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 bupivacaine, 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. Failure to attain informed consent from the patient due to age or level of consciousness
7. Voluntary or involuntary withdraw from the study
8. Referral to another health centre or Hospital for further management.

Primary outcomes:
measure: Pain measurement
timeFrame: at 8 hours after intervention
measure: Pain measurement
timeFrame: at 16 hours after intervention
measure: Pain measurement
timeFrame: at 24 hours after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mbarara University of Science and Technology
name: Andrew Kwikiriza, MD
role: PRINCIPAL_INVESTIGATOR
References: