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NCT Number: NCT01931215

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

spinal anesthesia with intrathecal morphine

Other

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

TAP-block with ropivacaine and clonidine

Other

Primary outcomes

  1. cumulative incidence of nausea and/or vomiting at 24 hours

    Time frame: 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 outcomes

  1. Cumulative incidence of pruritus at 24h

    Time frame: 24 h

    inquired directly from the patient at 6 and 24h

  2. Cumulative incidence of treated nausea and vomiting at 24h

    Time frame: 24h

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

  3. Cumulative incidence of sedation at 6 and 24h.

    Time frame: 24h

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

  4. Cumulative incidence of arterial hypotension

    Time frame: 24h

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

  5. Cumulative incidence of bradycardia

    Time frame: 24h

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

  6. Cumulative incidence of respiratory depression

    Time frame: 24h

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

  7. Cumulative morphine consumption at 24 hours

    Time frame: 24h

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

  8. Time until first PCA request

    Time frame: 24h

    (recorded in the memory of the PCA pump

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

    Time frame: 48h

    using the NRS scale (0-10)

  10. Pain score on movement

    Time frame: 48h

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

  11. Maternal satisfaction at 24 and 48 hours postoperatively

    Time frame: 48h

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

  12. persistent pain at 3 and 6 months postoperatively

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Benno Rehberg-Klug

Other

Collaborators

  • Domitille Dereu

Registry information

Acronym: MOTAP

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2013
Registry last updated
Nov 21, 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.

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