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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Ceasarian Section, Anaesthesia
• Intervention / Treatment: Drug: Intrathecal morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; ITM group were given; Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia; 100 micrograms of preservative-free morphine.	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; Other Names: Intrathecal
ACTIVE_COMPARATOR: Control; TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.	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; Other Names: Intrathecal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measurement	Pain measurement using the numerical rating scale (NRS).	at 8 hours after intervention
Pain measurement	Pain measurement using the numerical rating scale (NRS).	at 16 hours after intervention
Pain measurement	Pain measurement using the numerical rating scale (NRS)	at 24 hours after intervention

Collaborators and Investigators

• Sponsor: Mbarara University of Science and Technology
• Investigators: Principal Investigator: Andrew Kwikiriza, MD, Mbarara University of Science and Technology

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2014
• Primary Completion (ACTUAL): June 20, 2016
• Study Completion (ACTUAL): June 20, 2016

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (ACTUAL): August 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: MUST/19/08-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared after relevant permissions have been obtained

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes