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

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT00799955

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery	Procedure: Placebo block Procedure: Ultrasound-guided TAP block	N/A

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.

Control group: standard care plus a placebo block.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Efficacy and Side Effects of Intrathecal Morphine and TAP Block for Post-cesarean Analgesia

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Procedure: Placebo block 100 micrograms of spinal morphine
Active Comparator: 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.	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

Arm

Intervention/Treatment

Placebo Comparator: 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.

Procedure: Placebo block

100 micrograms of spinal morphine

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

Morphine equivalents used in the 24h post-delivery [24 hours post operation]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BC Women's Hospital Dept of Anesthesia	Vancouver	British Columbia	Canada	V6H 3N1

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator: Roanne Preston, MD, FRCPC, University of British Columbia
Study Director: 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