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

NCT03263689 | Completed Phase 3 FDA Drug

• 1 other identifier: MUST/19/08-14
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy, Ceasarian Section, Anaesthesia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

ITM group were given 1. Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia 2. 100 micrograms of preservative-free morphine.

Drug: Intrathecal morphine

Control

ACTIVE COMPARATOR

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

Drug: Intrathecal morphine

Interventions

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

Also known as: Intrathecal

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women in labor with indication for ceasarian section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead

MeSH Terms

Interventions

Injections, Spinal

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Andrew Kwikiriza, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subjects were randomly assigned to a study group (intrathecal morphine - ITM group - or TAP - TAP group) by a computer random number generator. Patients were blinded to their study allocation. Those in the 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. The TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 28, 2017
• Study Start: March 15, 2014
• Primary Completion: June 20, 2016
• Study Completion: June 20, 2016
• Last Updated: August 28, 2017

Record last verified: 2017-08