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

NCT ID: NCT03263689

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-15
• Study Completion Date: 2016-06-20

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.

Conditions

Pregnancy, Ceasarian Section, Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

ITM group were given

1. Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia

2. 100 micrograms of preservative-free morphine.

Group Type: EXPERIMENTAL

Intrathecal morphine

Intervention Type: DRUG

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

Control

TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.

Group Type: ACTIVE_COMPARATOR

Intrathecal morphine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Intrathecal

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mbarara University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Kwikiriza, MD

Role: PRINCIPAL_INVESTIGATOR

Mbarara University of Science and Technology

Other Identifiers

MUST/19/08-14

Identifier Type: -

Identifier Source: org_study_id