TAP Catheters Versus Intrathecal Morphine for Cesarean Section

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Stamford Anesthesiology Services, PC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
Dr. Vlad Frenk, Stamford Anesthesiology Services, PC
ClinicalTrials.gov Identifier:
NCT01593280
First received: April 30, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and pruritus, which may affect quality of recovery. The investigators hypothesize that long-acting local anesthetic infusions via TAP catheter can provide better quality of recovery after cesarean section than spinal morphine.


Condition Intervention
Abdominal Muscles/Ultrasonography
Adult
Anesthetics, Local/Administration & Dosage
Ropivacaine/Administration & Dosage
Ropivacaine/Analogs & Derivatives
Cesarean Section
Humans
Nerve Block/Methods
Pain Measurement/Methods
Pain, Postoperative/Prevention & Control
Ultrasonography, Interventional
Device: TAP catheter
Drug: intrathecal morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quality of Recovery Following Administration of Transverse Abdominus Plane (TAP) Catheter as Compared to Intrathecal Morphine After Cesarean Delivery Under Spinal Anesthesia: a Prospective, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Stamford Anesthesiology Services, PC:

Primary Outcome Measures:
  • Quality of recovery after cesarean section [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    To determine whether using continuous TAP catheters would result in a better quality of recovery after elective cesarean section under spinal anesthesia as compared to intrathecal morphine using QoR-40 questionnaire


Secondary Outcome Measures:
  • Incidence of nausea/vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    nausea scores (0-2) and daily dose of antiemetic

  • incidence and severity of pruritus [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    pruritis on 0-2 scale. Daily dose of antipruritic medications

  • overall oral narcotic use during the 48 hours post-operatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Postoperative data collection will include pain scores (0-10) and daily oral narcotic use


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAP catheter
Indwelling TAP catheter placed at the end of c-section. It will be dosed with 20ml of Ropivacaine 0.5% at that time. Double lumen OnQ C-block pump containing 700 ml of the Ropivacaine 0.2% will be attached to the TAP catheters in the recovery room. The catheters will run at 7cc/hr/side for 50 hrs.
Device: TAP catheter
dosed with 20ml of Ropivacaine 0.5% at that time. Double lumen pump containing 700 ml of the Ropivacaine 0.2% will be attached to the TAP catheters in the recovery room. The time that this occurs will be recorded in the eMAR. The catheters will run at 7cc/hr/side for 50 hrs.
Other Name: On Q pump
Active Comparator: intrathecal morphine
0.3 mg of intrathecal morphine
Drug: intrathecal morphine
0.3 mg
Other Name: Duramorph

Detailed Description:

This study is a prospective, open, randomized study. Subjects will be randomized using a computer-generated table of random numbers into 2 groups. The first group will receive intrathecal morphine as part of a spinal anesthetic. The second group will receive an ultrasound-guided bilateral TAP catheter at the end of the procedure, while the subject is still under the effect of spinal anesthetic. Group assignments will be sealed in sequentially numbered, opaque envelopes that would be opened by an anesthesiologist performing the cesarean section. The research nurse or one of the investigators, not involved with patient care after the subject signed written informed consent, will provide postoperative data collection.

All patients will be pre-hydrated with 1000ml of Lactated Ringer's solution. They will then be brought to the OR and without premedication receive a spinal anesthetic in a sitting position. The spinal anesthetic will be administered at either L3-4 or L4-5 level with 24G Sprotte needle and contain 1.4ml of 0.75% hyperbaric bupivacaine. As per protocol, the first group would receive 0.3mg of preservative-free morphine, mixed in the same syringe. All the subjects then will be immediately placed in supine position with left uterine displacement, and supplemental oxygen 4L/min will be administered via nasal cannula for the duration of procedure. After a successful spinal anesthetic is confirmed by loss of sensation to pinprick, cesarean section will be performed. Intraoperative hypotension will be treated with IV fluids, as well as intermittent boluses of IV ephedrine or IV neosynephrine as needed to keep SBP>100mm Hg. Intraoperative nausea will be treated with IV ondansetron as needed.

At the end of the procedure, the second group will receive ultrasound guided TAP catheter using a linear 6-15MHz ultrasound probe on a portable ultrasound machine (SonoSite, Bothell, WA) as previously described (Hebbard P, 2007). Each catheter will be dosed with 20ml of Ropivacaine 0.5% at that time. Double lumen OnQ C-block pump (I-Flow, LLC, Lake Forest, CA) containing 700 ml of the Ropivacaine 0.2% will be attached to the TAP catheters in the recovery room. The time that this occurs will be recorded in the eMAR. The catheters will run at 7cc/hr/side for 50 hrs.

In the recovery area, the patient will be asked to rate their pain at rest, nausea, and pruritus upon arrival and at regular intervals as per routine care. The pain will be rated on a 0 to 10 numeric rating scale (NRS), where 0 means no pain and 10 is the worst pain imaginable. Fentanyl 50 mg IV will be administered every 5 minutes to maintain an NRS pain score <4 of 10. Nausea will be rated on a 0 to 2 scale (0 = no nausea and vomiting, 1 = mild to moderate nausea or vomiting not needing treatment, and 2 = severe nausea or vomiting needing treatment). It will be treated with 4mg IV ondansetron, if necessary. The presence of pruritus and whether the treatment is desired will be assessed on a 0 to 2 scale (0= no pruritus, 1= mild pruritus not requiring treatment, 2= moderate pruritus requiring treatment or severe pruritus). Pruritus will be treated with IV diphenhydramine 25 mg if the subject weighs less than 150lbs and 50mg if the subjects weighs more than 150lbs. Upon transfer to the maternity floor, the nurses will ask the subjects to rate their pain at rest, nausea, and pruritus as part of usual care, upon arrival and every 4 hours for 48 hours as described above. The answers will be recorded on a data collection too. For the following 48 hours, the patient will be treated as follows: nausea will be treated with 25 mg IV promethazine followed by 4mg IV ondansetron if necessary every 6 hours. Pruritus will be treated with IV/PO diphenhydramine 25 mg if the subject weighs less than 150lbs and 50mg if the subject weighs more than 150lbs every 6 hours if necessary. Pain will be treated with SQ morphine (4mg for NRS pain 3-4, 6 mg for NRS pain 4-7, 8mg for NRS pain >7) every 4 hours as requested and 30mg IV ketorolac every 6 hours until subjects start eating. Once the subject tolerate diet, their pain will be treated with 800 mg PO ibuprofen every 6 hours and a combination of oxycodone 5mg and acetaminophen 325mg PO every 4 hours as requested (1 tab for NRS pain 4-7, 2 tabs for NRS pain >7).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 18 - 45 years of age undergoing cesarean section under spinal anesthesia.
  • Ability to read and write English

Exclusion Criteria:

  • Patients undergoing other concomitant procedure
  • Patients with history of diabetes or chronic steroid use
  • Patients with chronic or recent (within 1 week prior to procedure) opioid use.
  • Patients without the mental capacity to consent for the procedure/study.
  • Patients requiring a translator in order to sign the consent for the procedure/study.
  • Patients with a history of allergic reactions to local anesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593280

Contacts
Contact: Vlad Frenk, MD 203 276-7490 vfrenk@stmahealth.org

Locations
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06904
Principal Investigator: Vlad Frenk, MD         
Sub-Investigator: Theresa Bowling, MD         
Sub-Investigator: Lance Bruck, MD         
Sub-Investigator: Maureen Burke, MD         
Sponsors and Collaborators
Stamford Anesthesiology Services, PC
I-Flow
  More Information

Publications:

Responsible Party: Dr. Vlad Frenk, attending anesthesiologist, Stamford Anesthesiology Services, PC
ClinicalTrials.gov Identifier: NCT01593280     History of Changes
Other Study ID Numbers: 12-0308.01
Study First Received: April 30, 2012
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stamford Anesthesiology Services, PC:
anesthesia
regional anesthetic techniques: transversus abdominis plane block,
pain, postoperative
surgery, cesarean section
quality of recovery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014