Comparing 2 Types of Pain Relief After Cesarean Delivery: Spinal Morphine and TAP Block

NCT00799955 | Completed DMC

• 1 other identifier: H08-01726
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Summary Brief Summary Standard care for pain relief after cesarean delivery is spinal morphine. Spinal morphine may be unsuitable for patients having general anesthetic or prior morphine-related side effects and can be less effective in patients with morphine tolerance. An alternative is a TAP block where local anesthetic is deposited between the abdominal muscles consequently numbing the area and providing pain relief. The investigators believe a TAP block will provide equivalent pain relief to spinal morphine.

Conditions

Cesarean Delivery

Keywords

Cesarean delivery; post-operative analgesia; TAP block; ultrasound

Outcome Measures

Primary Outcomes (1)

• Morphine equivalents used in the 24h post-delivery

  24 hours post operation

Secondary Outcomes (1)

• Pain scores at rest, and with movement as assessed by verbal analogue score on arrival to recovery and at 2, 6, 10, and 24h post-spinal drug administration; post-operative nausea and vomiting scores, sedation score, presence or absence of itch; presence

  3 months

Study Arms (2)

1

PLACEBO COMPARATOR

Subjects will receive 100 micrograms of spinal morphine, at the time of spinal needle insertion (standard care at BCW). At the end of the case, one of two investigators, using ultrasound, will visualize the transversus abdominis plane. A capped needle will be pushed against the skin to mimic the pressure sensation of the TAP block. The needle will not break the skin and nothing will be injected in this control group. The procedure will then be repeated on the other side. A dressing will be applied on each side to blind the subject and researcher to which group she is in.

Procedure: Placebo block

2

ACTIVE COMPARATOR

No additional spinal medications will be given. At the end of the case, one of the two investigators, under sterile conditions, and using ultrasound, will visualize the tip of a blunt regional anaesthesia needle entering the transversus abdominis plane. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0. 5% ropivacaine (to maximum dose of 20 mls = 100mg on each side) will be injected, under vision, into the transversus abdominis plane, on each side. The subjects will still have spinal anesthesia of the abdomen and therefore will not feel needle insertion as sharp although most will have a sensation of pressure. A dressing will be applied over the needle's entry points.

Procedure: Ultrasound-guided TAP block

Interventions

Placebo block PROCEDURE

100 micrograms of spinal morphine

1

Ultrasound-guided TAP block PROCEDURE

1.5mg/kg of 0. 5% ropivacaine (to maximum dose of 20 mls = 100mg on each side) will be injected into the transversus abdominis plane, on each side

2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective cesarean delivery under spinal anesthesia patients.
• \>28 weeks gestation
• ASA 1 and 2 classification of health
• Mothers presenting to the assessment unit with ruptured membranes or in early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery.
• Able to read and understand English,
• Only patients expected to deliver before midday will be approached for participation in the trial to facilitate post-operative data collection.

You may not qualify if:

• Mothers in active labour
• ASA classification 3 or above
• Emergency cesarean delivery for fetal heart rate abnormalities
• Cesarean delivery under general anesthesia
• Maternal age \<19
• BMI \>40.
• Cesarean deliveries where a CSE is planned.
• Mothers with a history of drug allergy to morphine or to local anesthetics
• Mothers who are likely to deviate from standard postpartum analgesia protocol because of history of morphine tolerance or sensitivity.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Women's Hospital Dept of Anesthesia

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Officials

• Roanne Preston, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Heather Loane, MBBS, B.Med.Sci

  University of British Columbia

  STUDY DIRECTOR

• Joanne Douglas, MD, FRCPC

  University of British Columbia

  STUDY DIRECTOR

• Simon Massey, MB BCh, MRCP, FRCA

  University of British Columbia

  STUDY DIRECTOR

• Jessica Tyler, BSc

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

CA (1)