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

Postoperative Pain Clinical Trial

— MOTAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931215
• Other study ID #: MOTAP
• Secondary ID: CER 12-112
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2013
• Last updated: November 20, 2017
• Start date: September 2013
• Est. completion date: August 28, 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 28, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• spinal anesthesia with intrathecal morphine
in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added
• TAP-block with ropivacaine and clonidine

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Benno Rehberg-Klug	Domitille Dereu

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Secondary	Cumulative incidence of pruritus at 24h	inquired directly from the patient at 6 and 24h	24 h
Secondary	Cumulative incidence of treated nausea and vomiting at 24h	(inquired directly from the patient at 6 and 24h).	24h
Secondary	Cumulative incidence of sedation at 6 and 24h.	Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4	24h
Secondary	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)	24h
Secondary	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)	24h
Secondary	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	24h
Secondary	Cumulative morphine consumption at 24 hours	(recorded in the memory of the patient controlled analgesia (PCA) pump).	24h
Secondary	Time until first PCA request	(recorded in the memory of the PCA pump	24h
Secondary	Pain score at rest at 6, 24 and 48 hours postoperatively	using the NRS scale (0-10)	48h
Secondary	Pain score on movement	at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).	48h
Secondary	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	48h
Secondary	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	6 months