Viewing Study NCT00799955



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Last Modification Date: 2024-10-26 @ 9:58 AM
Study NCT ID: NCT00799955
Status: COMPLETED
Last Update Posted: 2013-01-23
First Post: 2008-11-26

Brief Title: Comparing 2 Types of Pain Relief After Cesarean Delivery Spinal Morphine and TAP Block
Sponsor: University of British Columbia
Organization: University of British Columbia

Study Overview

Official Title: Comparison of Efficacy and Side Effects of Intrathecal Morphine and TAP Block for Post-cesarean Analgesia
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None