TAP Catheters Versus Intrathecal Morphine for Cesarean Section
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| ClinicalTrials.gov Identifier: NCT01593280 |
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Recruitment Status : Unknown
Verified May 2012 by Dr. Vlad Frenk, Stamford Anesthesiology Services, PC.
Recruitment status was: Recruiting
First Posted : May 8, 2012
Last Update Posted : May 8, 2012
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| Condition or disease | Intervention/treatment | Phase |
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| 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 | Not Applicable |
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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | May 2012 |
| Estimated Primary Completion Date : | February 2013 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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Active Comparator: intrathecal morphine
0.3 mg of intrathecal morphine
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Drug: intrathecal morphine
0.3 mg
Other Name: Duramorph |
- Quality of recovery after cesarean section [ Time Frame: 48 hours ]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
- Incidence of nausea/vomiting [ Time Frame: 48 hours ]nausea scores (0-2) and daily dose of antiemetic
- incidence and severity of pruritus [ Time Frame: 48 hours ]pruritis on 0-2 scale. Daily dose of antipruritic medications
- overall oral narcotic use during the 48 hours post-operatively [ Time Frame: 48 hours ]Postoperative data collection will include pain scores (0-10) and daily oral narcotic use
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593280
| Contact: Vlad Frenk, MD | 203 276-7490 | vfrenk@stmahealth.org |
| 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 | |
| Responsible Party: | Dr. Vlad Frenk, attending anesthesiologist, Stamford Anesthesiology Services, PC |
| ClinicalTrials.gov Identifier: | NCT01593280 |
| Other Study ID Numbers: |
12-0308.01 |
| First Posted: | May 8, 2012 Key Record Dates |
| Last Update Posted: | May 8, 2012 |
| Last Verified: | May 2012 |
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anesthesia regional anesthetic techniques: transversus abdominis plane block, pain, postoperative surgery, cesarean section quality of recovery |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Morphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |