Cesarean Section Clinical Trial
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
NCT number | NCT01593280 |
Other study ID # | 12-0308.01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | April 30, 2012 |
Last updated | May 7, 2012 |
Start date | May 2012 |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stamford Hospital | Stamford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Stamford Anesthesiology Services, PC | I-Flow |
United States,
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):1789-93, table of contents. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Incidence of nausea/vomiting | nausea scores (0-2) and daily dose of antiemetic | 48 hours | No |
Secondary | incidence and severity of pruritus | pruritis on 0-2 scale. Daily dose of antipruritic medications | 48 hours | No |
Secondary | overall oral narcotic use during the 48 hours post-operatively | Postoperative data collection will include pain scores (0-10) and daily oral narcotic use | 48 hours | No |
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