Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
NCT ID: NCT03695172
Last Updated: 2022-01-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
12 participants
INTERVENTIONAL
2019-09-12
2021-03-20
Brief Summary
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Detailed Description
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Patients who consent to be in this study will be randomized to receive one of three truncal nerve blocks using an online randomization program by the study PI (AK/EG): (1) ultrasound-guided bilateral classic TAP block; (2) ultrasound-guided bilateral anterior QL (also known as transmuscular or QL type 3) block; (3) ultrasound-guided bilateral ESP block at the level of T9. These nerve blocks will be performed after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. Nerve blocks will be performed by a dedicated and trained group of regional anesthesiologists. This non-blinded regional anesthesiologist will save an ultrasound image after local anesthetic administration while the needle is still in position on each side. The study team will review these images to ensure a high quality of block performance.
Patients will have standard postoperative pain medication orders, including acetaminophen 975 mg PO Q6H for 4 days (scheduled, starting 6 hours after intraoperative rectal dose), ketorolac 15 mg IV Q6H for 24 hours (scheduled, starting 6 hours after intraoperative dose), ibuprofen 600 mg PO Q6H for 3 days (scheduled, starting 24 hours after first dose of ketorolac) and oxycodone 5-10mg PO Q3-4H PRN for 4 days. If patients are unable to tolerate oral medication or oxycodone is insufficient, rescue medications may be ordered: IV morphine 1-2 mg or IV hydromorphone 0.3-0.5 mg Q4H as needed. There is no change from the standard postoperative order sets used for patients after cesarean section.
Subjects' verbal pain scores at rest and with movement as well as opioid consumption will be recorded at 2, 6, 24, and 48 hours postoperatively. Additionally, the amount of antiemetics and antipruritics used will also be recorded at the above time points. These scores will be entered into a Duke University Hospital REDCap database. Subjects will also be sent a survey assessing their satisfaction with pain control one week after discharge via email or telephone. This information will be collected via Duke University Hospital REDCap.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAP block
Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine
TAP block
Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
QL block
Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine
QL block
Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
ESP block
Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine
ESP block
Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side.
Interventions
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Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine
TAP block
Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
QL block
Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
ESP block
Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side.
Eligibility Criteria
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Inclusion Criteria
2. Age greater than or equal to 18 years
3. Scheduled for elective cesarean section
4. English speaking
Exclusion Criteria
2. Diagnosis of chronic pain
3. Chronic opioid use (opioid use in the past 3 months)
4. Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor), gabapentin, or pregabalin (Lyrica)
5. Inability to cooperate with or understand protocol
6. Inability to communicate pain scores or need for analgesia
7. Infection at the site of block placement
8. Intolerance or allergy to local anesthetics
9. Neurologic deficit or disorder
10. Blood thinning disorder or taking anticoagulant medication
11. BMI \> 50 kg/m2
12. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
14. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
18 Years
FEMALE
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Amanda Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Duke
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Marcus MA, Brodner G. Are opioids contraindicated as postoperative pain relief for patients who are breast-feeding their newborn? Curr Opin Anaesthesiol. 2001 Jun;14(3):287-9. doi: 10.1097/00001503-200106000-00001. No abstract available.
Marcus H, Gerbershagen HJ, Peelen LM, Aduckathil S, Kappen TH, Kalkman CJ, Meissner W, Stamer UM. Quality of pain treatment after caesarean section: Results of a multicentre cohort study. Eur J Pain. 2015 Aug;19(7):929-39. doi: 10.1002/ejp.619. Epub 2014 Nov 21.
Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
Osmundson SS, Schornack LA, Grasch JL, Zuckerwise LC, Young JL, Richardson MG. Postdischarge Opioid Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):36-41. doi: 10.1097/AOG.0000000000002095.
Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
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.
Fusco P, Scimia P, Paladini G, Fiorenzi M, Petrucci E, Pozone T, Vacca F, Behr A, Micaglio M, Danelli G, Cofini V, Necozione S, Carta G, Petrini F, Marinangeli F. Transversus abdominis plane block for analgesia after Cesarean delivery. A systematic review. Minerva Anestesiol. 2015 Feb;81(2):195-204. Epub 2014 Apr 16.
Factor D, Chin KJ. Transversus abdominis plane block in lower segment cesarean section: a question of block failure or lack of efficacy? Reg Anesth Pain Med. 2010 Jul-Aug;35(4):404-5. doi: 10.1097/AAP.0b013e3181e66f01. No abstract available.
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.
Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
Kadam VR, Howell S. Ultrasound-guided continuous transmuscular quadratus lumborum block- L4 or L2 level catheter insertion for analgesia in open abdominal surgery: Case series. Indian J Anaesth. 2018 Jul;62(7):555-557. doi: 10.4103/ija.IJA_242_18. No abstract available.
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Chin KJ. Erector spinae plane block in abdominal surgery: Case series. Indian J Anaesth. 2018 Jul;62(7):549-554. doi: 10.4103/ija.IJA_57_18.
Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
Yamak Altinpulluk E, Garcia Simon D, Fajardo-Perez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. English, Spanish.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00100742
Identifier Type: -
Identifier Source: org_study_id
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