Transversus Abdominis Plane Block Versus Spinal Morphine... | NCT03263689

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

NCT03263689

Sponsor

Mbarara University of Science and Technology

Status

Completed

Last Update Posted

Aug 28, 2017Actual

Enrollment

130Actual

Phase

Phase 3

Conditions

Pregnancy, Ceasarian Section, Anaesthesia

Interventions

Intrathecal morphine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2014Actual

Primary Completion Date

Jun 20, 2016Actual

Completion Date

Jun 20, 2016Actual

First Submitted Date

Aug 16, 2017

First Submission Date that Met QC Criteria

Aug 23, 2017

First Posted Date

Aug 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2017

Last Update Posted Date

Aug 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	ITM group were given Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia 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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women in labor with indication for ceasarian section

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Andrew Kwikiriza, MD	Mbarara University of Science and Technology	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data will be shared after relevant permissions have been obtained

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007278	Injections, Spinal

Ancestor Terms

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.

Masking Info

Masking

Single

Masking Description

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.

Who Masked

Participant