TAP Catheters Versus Intrathecal Morphine for Cesarean Section

NCT01593280 | Unknown DMC

• 1 other identifier: 12-0308.01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Secondary Outcomes (3)

• Incidence of nausea/vomiting

  48 hours

• incidence and severity of pruritus

  48 hours

• overall oral narcotic use during the 48 hours post-operatively

  48 hours

Study Arms (2)

TAP catheter

ACTIVE COMPARATOR

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

intrathecal morphine

ACTIVE COMPARATOR

0.3 mg of intrathecal morphine

Drug: intrathecal morphine

Interventions

TAP catheter DEVICE

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.

Also known as: On Q pump

TAP catheter

intrathecal morphine DRUG

0.3 mg

Also known as: Duramorph

intrathecal morphine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stamford Anesthesiology Services, PC: lead
• I-Flow: collaborator

Study Sites (1)

Stamford Hospital

Stamford, Connecticut, 06904, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 18020088 BACKGROUND

• 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.

  PMID: 22410586 BACKGROUND

• 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.

  PMID: 22354671 BACKGROUND

• 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.

  PMID: 21498494 BACKGROUND

• 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.

  PMID: 19916252 BACKGROUND

• 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.

  PMID: 18165577 BACKGROUND

• 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.

  PMID: 12761013 BACKGROUND

• 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.

  PMID: 21926373 BACKGROUND

• 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.

  PMID: 10740540 BACKGROUND

• 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.

  PMID: 17717242 BACKGROUND

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Vlad Frenk, MD

CONTACT

203 276-7490; vfrenk@stmahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending anesthesiologist

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2013
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

US (1)