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

NCT ID: NCT00799955

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-04-30

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.

Detailed Description

Detailed Description In North America, the standard of care is neuraxial morphine. This is an effective analgesic, but can still cause problems with nausea, vomiting and itching. Spinal morphine may be unsuitable for patients who have had morphine-related side effects in the past and can be less effective in patients with morphine tolerance. It is also poorly suited for patients who have had a general anesthetic, as anesthesiologists do not routinely access the spinal space purely for analgesia. It is only when they are using the spinal route for surgical anesthesia, that they will also deposit morphine to provide pain relief after surgery.

The abdominal wall incision is an important contributor to pain following a cesarean delivery. The nerves supplying the anterior abdominal wall between the internal oblique and transversus abdominis muscles. By depositing local anesthetic solution between these muscles on each side, it is possible to block all these nerves and provide analgesia for the incision of the anterior abdominal wall. This is known as the transversus abdominis plane block or TAP block.

Studies have shown the TAP block to be useful for midline laparotomies for open prostatectomies, bowel resection and as rescue analgesia for abdominal surgery. There are two studies which look specifically at TAP block after cesarean delivery but none of them have compared it directly the current standard.

This study is a direct comparison of spinal morphine and TAP block. Obviously, adequate analgesia is of paramount importance to the patient and those caring for her. Studies to date indicate that the TAP block provides similar analgesia to spinal morphine in the early post-operative period. Therefore it would be a reasonable alternative for those patients who cannot have spinal morphine or who can not tolerate spinal morphine due to its side effects.

The primary objective will be to investigate whether the tranversus abdominis plane block provides equivalent analgesia post-cesarean delivery, as intrathecal morphine.

The secondary objective will be to determine whether there is a difference in post-operative abdominal scar pain, at three months post-surgery.

This study will be a prospective, randomized, placebo-controlled, double blinded study.

The study will involve two groups. Both groups will have spinal anesthesia for the surgery provided with 9-12 mg heavy bupivacaine and 10 mcg fentanyl.

1. Control group: standard care plus a placebo block.

2. Intervention group: no additional spinal medications will be given and an ultrasound-guided TAP Block will be given instead of the standard intrathecal morphine.

Standard post-cesarean analgesia and PONV orders will be resumed post-delivery.

Conditions

Cesarean Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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.

Group Type: PLACEBO_COMPARATOR

Placebo block

Intervention Type: PROCEDURE

100 micrograms of spinal morphine

2

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided TAP block

Intervention Type: 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

Interventions

Placebo block

100 micrograms of spinal morphine

Intervention Type: PROCEDURE

Ultrasound-guided TAP block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roanne Preston, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Heather Loane, MBBS, B.Med.Sci

Role: STUDY_DIRECTOR

University of British Columbia

Joanne Douglas, MD, FRCPC

Role: STUDY_DIRECTOR

University of British Columbia

Simon Massey, MB BCh, MRCP, FRCA

Role: STUDY_DIRECTOR

University of British Columbia

Jessica Tyler, BSc

Role: STUDY_DIRECTOR

University of British Columbia

Locations

BC Women's Hospital Dept of Anesthesia

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H08-01726

Identifier Type: -

Identifier Source: org_study_id