TAP Catheters Versus Intrathecal Morphine for Cesarean Section
Primary Purpose
Abdominal Muscles/Ultrasonography, Adult, Anesthetics, Local/Administration & Dosage
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP catheter
intrathecal morphine
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Muscles/Ultrasonography focused on measuring anesthesia, regional anesthetic techniques: transversus abdominis plane block,, pain, postoperative, surgery, cesarean section, quality of recovery
Eligibility 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
Sites / Locations
- Stamford HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TAP catheter
intrathecal morphine
Arm Description
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.
0.3 mg of intrathecal morphine
Outcomes
Primary Outcome Measures
Quality of recovery after cesarean section
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
nausea scores (0-2) and daily dose of antiemetic
incidence and severity of pruritus
pruritis on 0-2 scale. Daily dose of antipruritic medications
overall oral narcotic use during the 48 hours post-operatively
Postoperative data collection will include pain scores (0-10) and daily oral narcotic use
Full Information
NCT ID
NCT01593280
First Posted
April 30, 2012
Last Updated
May 7, 2012
Sponsor
Stamford Anesthesiology Services, PC
Collaborators
I-Flow
1. Study Identification
Unique Protocol Identification Number
NCT01593280
Brief Title
TAP Catheters Versus Intrathecal Morphine for Cesarean Section
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stamford Anesthesiology Services, PC
Collaborators
I-Flow
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
anesthesia, regional anesthetic techniques: transversus abdominis plane block,, pain, postoperative, surgery, cesarean section, quality of recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAP catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
intrathecal morphine
Arm Type
Active Comparator
Arm Description
0.3 mg of intrathecal morphine
Intervention Type
Device
Intervention Name(s)
TAP catheter
Other Intervention Name(s)
On Q pump
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
intrathecal morphine
Other Intervention Name(s)
Duramorph
Intervention Description
0.3 mg
Primary Outcome Measure Information:
Title
Quality of recovery after cesarean section
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Incidence of nausea/vomiting
Description
nausea scores (0-2) and daily dose of antiemetic
Time Frame
48 hours
Title
incidence and severity of pruritus
Description
pruritis on 0-2 scale. Daily dose of antipruritic medications
Time Frame
48 hours
Title
overall oral narcotic use during the 48 hours post-operatively
Description
Postoperative data collection will include pain scores (0-10) and daily oral narcotic use
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vlad Frenk, MD
Phone
203 276-7490
Email
vfrenk@stmahealth.org
Facility Information:
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vlad Frenk, MD
First Name & Middle Initial & Last Name & Degree
Theresa Bowling, MD
First Name & Middle Initial & Last Name & Degree
Lance Bruck, MD
First Name & Middle Initial & Last Name & Degree
Maureen Burke, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
18020088
Citation
Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
Results Reference
background
PubMed Identifier
22410586
Citation
Loane H, Preston R, Douglas MJ, Massey S, Papsdorf M, Tyler J. A randomized controlled trial comparing intrathecal morphine with transversus abdominis plane block for post-cesarean delivery analgesia. Int J Obstet Anesth. 2012 Apr;21(2):112-8. doi: 10.1016/j.ijoa.2012.02.005. Epub 2012 Mar 10.
Results Reference
background
PubMed Identifier
22354671
Citation
Eslamian L, Jalili Z, Jamal A, Marsoosi V, Movafegh A. Transversus abdominis plane block reduces postoperative pain intensity and analgesic consumption in elective cesarean delivery under general anesthesia. J Anesth. 2012 Jun;26(3):334-8. doi: 10.1007/s00540-012-1336-3. Epub 2012 Feb 22.
Results Reference
background
PubMed Identifier
21498494
Citation
McMorrow RC, Ni Mhuircheartaigh RJ, Ahmed KA, Aslani A, Ng SC, Conrick-Martin I, Dowling JJ, Gaffney A, Loughrey JP, McCaul CL. Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section. Br J Anaesth. 2011 May;106(5):706-12. doi: 10.1093/bja/aer061.
Results Reference
background
PubMed Identifier
19916252
Citation
Costello JF, Moore AR, Wieczorek PM, Macarthur AJ, Balki M, Carvalho JC. The transversus abdominis plane block, when used as part of a multimodal regimen inclusive of intrathecal morphine, does not improve analgesia after cesarean delivery. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):586-9. doi: 10.1097/aap.0b013e3181b4c922.
Results Reference
background
PubMed Identifier
18165577
Citation
McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
Results Reference
background
PubMed Identifier
12761013
Citation
Charuluxananan S, Kyokong O, Somboonviboon W, Narasethakamol A, Promlok P. Nalbuphine versus ondansetron for prevention of intrathecal morphine-induced pruritus after cesarean delivery. Anesth Analg. 2003 Jun;96(6):1789-1793. doi: 10.1213/01.ANE.0000066015.21364.7D.
Results Reference
background
PubMed Identifier
21926373
Citation
De Oliveira GS Jr, Fitzgerald PC, Marcus RJ, Ahmad S, McCarthy RJ. A dose-ranging study of the effect of transversus abdominis block on postoperative quality of recovery and analgesia after outpatient laparoscopy. Anesth Analg. 2011 Nov;113(5):1218-25. doi: 10.1213/ANE.0b013e3182303a1a. Epub 2011 Sep 16.
Results Reference
background
PubMed Identifier
10740540
Citation
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
Results Reference
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PubMed Identifier
17717242
Citation
Liu SS, Wu CL. The effect of analgesic technique on postoperative patient-reported outcomes including analgesia: a systematic review. Anesth Analg. 2007 Sep;105(3):789-808. doi: 10.1213/01.ane.0000278089.16848.1e.
Results Reference
background
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TAP Catheters Versus Intrathecal Morphine for Cesarean Section
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