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Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial (MOTAP)

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

spinal anesthesia with intrathecal morphine

TAP-block with ropivacaine and clonidine

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must satisfy all of the following criteria to be enrolled into the study:

American Society of Anesthesiology (ASA) physical status less than 3 Able to read and understand the information sheet and to sign and date the consent form
Scheduled for elective C-section planned with spinal anaesthesia
Age>18

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

Complicated pregnancy defined as having preeclampsia or placenta accreta, increta and percreta.
Drug addiction.
Contraindication to spinal anaesthesia (history of clotting disorders, septicemia, local infection at the injection site, spinal malformation, elevated intracranial pressure)
Contraindication to TAP block (skin infection, abdominal wall muscle defect such as hernia and previous abdominal wall mesh).
BMI>40 kg/m2
Weight less than 50 kg the day of the C-section.
Height less than 150 cm or more than 175 cm.
Allergy/contraindication to any medication used in the study.
Previous median abdominal incision. Necessity to perform the C-section urgently before the scheduled date (with less than 24h preparation time).

Sites / Locations

Hôpitaux Universitaires de Genève

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

morphine group

TAP group

Arm Description

spinal anesthesia with intrathecal morphine

TAP-block with ropivacaine and clonidine

Outcomes

Primary Outcome Measures

cumulative incidence of nausea and/or vomiting at 24 hours

Data for this endpoint will be gathered at 6h and 24h postoperatively from nurses' records in the recovery room (at 6h) and on the ward (at 24h), and counterchecked by asking the patient

Secondary Outcome Measures

Cumulative incidence of pruritus at 24h

inquired directly from the patient at 6 and 24h

Cumulative incidence of treated nausea and vomiting at 24h

(inquired directly from the patient at 6 and 24h).

Cumulative incidence of sedation at 6 and 24h.

Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4

Cumulative incidence of arterial hypotension

defined as a systolic blood pressure of less than 100 mmHg for longer than 5 minutes (from nurse records at 6 and 24h)

Cumulative incidence of bradycardia

defined as a heart rate of less than 50/min for longer than 5 minutes (from nurse records at 6 and 24h)

Cumulative incidence of respiratory depression

defined as a respiratory frequency of less than 8/min for longer than 5 minutes (from nurse records at 6 and 24h

Cumulative morphine consumption at 24 hours

(recorded in the memory of the patient controlled analgesia (PCA) pump).

Time until first PCA request

(recorded in the memory of the PCA pump

Pain score at rest at 6, 24 and 48 hours postoperatively

using the NRS scale (0-10)

Pain score on movement

at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).

Maternal satisfaction at 24 and 48 hours postoperatively

measured on a numeric rating scale (at 6h) and with the questionnaire "quality of recovery" (QoR40) at 24 and 48h

persistent pain at 3 and 6 months postoperatively

Pain at rest, 0-10 pain scale; Pain on movement, 0-10 pain scale; Yes/no for scar pain;Yes/no for analgesic use

Full Information

NCT ID

NCT01931215

First Posted

August 22, 2013

Last Updated

November 20, 2017

Sponsor

Benno Rehberg-Klug

Collaborators

Domitille Dereu

1. Study Identification

Unique Protocol Identification Number

NCT01931215

Brief Title

Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial

Acronym

MOTAP

Official Title

Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Benno Rehberg-Klug

Collaborators

Domitille Dereu

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common. Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects. With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine. The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

treatment versus placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

pharmacy providing identical sets of study drugs and placebo, computerized random sequence generation, sequence held by the pharmacy until study completion

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

morphine group

Arm Type

Active Comparator

Arm Description

spinal anesthesia with intrathecal morphine

Arm Title

TAP group

Arm Type

Experimental

Arm Description

TAP-block with ropivacaine and clonidine

Intervention Type

Other

Intervention Name(s)

spinal anesthesia with intrathecal morphine

Intervention Description

in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added

Intervention Type

Other

Intervention Name(s)

TAP-block with ropivacaine and clonidine

Primary Outcome Measure Information:

Title

cumulative incidence of nausea and/or vomiting at 24 hours

Description

Data for this endpoint will be gathered at 6h and 24h postoperatively from nurses' records in the recovery room (at 6h) and on the ward (at 24h), and counterchecked by asking the patient

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Cumulative incidence of pruritus at 24h

Description

inquired directly from the patient at 6 and 24h

Time Frame

24 h

Title

Cumulative incidence of treated nausea and vomiting at 24h

Description

(inquired directly from the patient at 6 and 24h).

Time Frame

24h

Title

Cumulative incidence of sedation at 6 and 24h.

Description

Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4

Time Frame

24h

Title

Cumulative incidence of arterial hypotension

Description

defined as a systolic blood pressure of less than 100 mmHg for longer than 5 minutes (from nurse records at 6 and 24h)

Time Frame

24h

Title

Cumulative incidence of bradycardia

Description

defined as a heart rate of less than 50/min for longer than 5 minutes (from nurse records at 6 and 24h)

Time Frame

24h

Title

Cumulative incidence of respiratory depression

Description

defined as a respiratory frequency of less than 8/min for longer than 5 minutes (from nurse records at 6 and 24h

Time Frame

24h

Title

Cumulative morphine consumption at 24 hours

Description

(recorded in the memory of the patient controlled analgesia (PCA) pump).

Time Frame

24h

Title

Time until first PCA request

Description

(recorded in the memory of the PCA pump

Time Frame

24h

Title

Pain score at rest at 6, 24 and 48 hours postoperatively

Description

using the NRS scale (0-10)

Time Frame

48h

Title

Pain score on movement

Description

at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).

Time Frame

48h

Title

Maternal satisfaction at 24 and 48 hours postoperatively

Description

measured on a numeric rating scale (at 6h) and with the questionnaire "quality of recovery" (QoR40) at 24 and 48h

Time Frame

48h

Title

persistent pain at 3 and 6 months postoperatively

Description

Pain at rest, 0-10 pain scale; Pain on movement, 0-10 pain scale; Yes/no for scar pain;Yes/no for analgesic use

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must satisfy all of the following criteria to be enrolled into the study: American Society of Anesthesiology (ASA) physical status less than 3 Able to read and understand the information sheet and to sign and date the consent form Scheduled for elective C-section planned with spinal anaesthesia Age>18 Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Complicated pregnancy defined as having preeclampsia or placenta accreta, increta and percreta. Drug addiction. Contraindication to spinal anaesthesia (history of clotting disorders, septicemia, local infection at the injection site, spinal malformation, elevated intracranial pressure) Contraindication to TAP block (skin infection, abdominal wall muscle defect such as hernia and previous abdominal wall mesh). BMI>40 kg/m2 Weight less than 50 kg the day of the C-section. Height less than 150 cm or more than 175 cm. Allergy/contraindication to any medication used in the study. Previous median abdominal incision. Necessity to perform the C-section urgently before the scheduled date (with less than 24h preparation time).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Domitille Dereu, MD

Organizational Affiliation

HUG

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Domitille Dereu, MD

Organizational Affiliation

HUG

Official's Role

Study Director

Facility Information:

Facility Name

Hôpitaux Universitaires de Genève

City

Geneva

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

31274545

Citation

Dereu D, Savoldelli GL, Mercier Y, Combescure C, Mathivon S, Rehberg B. The impact of a transversus abdominis plane block including clonidine vs. intrathecal morphine on nausea and vomiting after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):575-582. doi: 10.1097/EJA.0000000000001013.

Results Reference

derived

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Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial

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