Transversus Abdominis Plane Block Versus Spinal Morphine After Caesarean Section : A Comparison Study

Pregnancy, Ceasarian Section, Anaesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263689
• Other study ID #: MUST/19/08-14
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2017
• Last updated: August 23, 2017
• Start date: March 15, 2014
• Est. completion date: June 20, 2016

Study information

• Verified date: August 2017
• Source: Mbarara University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 20, 2016
• Est. primary completion date: June 20, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy, Ceasarian Section, Anaesthesia

Intervention

Drug:
• Intrathecal morphine
ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurement	Pain measurement using the numerical rating scale (NRS).	at 8 hours after intervention
Primary	Pain measurement	Pain measurement using the numerical rating scale (NRS).	at 16 hours after intervention
Primary	Pain measurement	Pain measurement using the numerical rating scale (NRS)	at 24 hours after intervention