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Completed

NCT Number: NCT03263689

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women between the age of 18-45;
  • Greater than 50 kilograms in weight;
  • Routine spinal anesthetic without sedation for an uncomplicated caesarean delivery via a low, transverse abdominal incision (Pfannenstiel);
  • In good health with no major medical problems including gastric ulcers, liver or renal dysfunction
  • 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

  • Patients with allergies to bupivacaine, paracetamol, or diclofenac;
  • Patients undergoing a surgical approach is other than a low, transverse abdominal incision (Pfannenstiel);
  • Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;
  • Prior complicated abdominal surgery;
  • Medical history of gastric ulcers, liver or kidney dysfunction; and
  • Patient refusal to be involved in the study. Failure to attain informed consent from the patient due to age or level of consciousness
  • Voluntary or involuntary withdraw from the study
  • Referral to another health centre or Hospital for further management.

Treatment and study plan

Intrathecal morphine

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

Other names: Intrathecal

Primary outcomes

  1. Pain measurement

    Time frame: at 8 hours after intervention

    Pain measurement using the numerical rating scale (NRS).

  2. Pain measurement

    Time frame: at 16 hours after intervention

    Pain measurement using the numerical rating scale (NRS).

  3. Pain measurement

    Time frame: at 24 hours after intervention

    Pain measurement using the numerical rating scale (NRS)

Sponsors and collaborators

Lead sponsor

Mbarara University of Science and Technology

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2017
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.