Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section

Pain, Postoperative Clinical Trial

Official title:

Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03695172
• Other study ID #: Pro00100742
• Status: Terminated
• Phase: Phase 4
• Start date: September 12, 2019
• Est. completion date: March 20, 2021

Study information

• Verified date: January 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.

Description:

The typical anesthetic for cesarean section at Duke University Hospital includes a spinal or combined spinal epidural anesthetic with intrathecal dosing of 1.4-1.6 mL bupivacaine HCl 0.75%, 15 mcg fentanyl, and 150 mcg morphine. If the epidural component of a combined spinal epidural anesthetic is used, the subject will be withdrawn from the study. Patients also receive rectal acetaminophen 975 mg prior to incision; intravenous (IV) ondansetron 4 mg, IV metoclopramide 10 mg, IV famotidine 20 mg and IV dexamethasone 4 mg intraoperatively; and IV ketorolac 15 mg prior to skin closure. There will be no change to this typical practice.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 20, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) Physical Status 1-3

2. Age greater than or equal to 18 years

3. Scheduled for elective cesarean section

4. English speaking

Exclusion Criteria:

1. ASA Physical Status 4-5

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

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine

Procedure:
• 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.

Biological:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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-naïve 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. — View Citation

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. Erratum in: Reg Anesth Pain Med. 2018;43:111. — View Citation

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. — 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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — 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

Luis-Navarro JC, Seda-Guzmán 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yamak Altinpulluk E, García Simón D, Fajardo-Pérez 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Opioid Consumption	Amount of opioid in milligrams.	2 hours postoperatively
Primary	Postoperative Opioid Consumption	Amount of opioid	6 hours postoperatively
Primary	Postoperative Opioid Consumption	Amount of opioid	24 hours postoperatively
Primary	Postoperative Opioid Consumption	Amount of opioid	48 hours postoperatively
Primary	Postoperative Pain Scores	Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable	2 hours postoperatively
Primary	Postoperative Pain Scores	Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable	6 hours postoperatively
Primary	Postoperative Pain Scores	Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable	24 hours postoperatively
Primary	Postoperative Pain Scores	Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable	48 hours postoperatively
Secondary	Number of Participants Requiring Antipruritics		2 hours postoperatively
Secondary	Number of Participants Requiring Antipruritics		6 hours postoperatively
Secondary	Number of Participants Requiring Antipruritics		24 hours postoperatively
Secondary	Number of Participants Requiring Antipruritics		48 hours postoperatively
Secondary	Number of Participants Requiring Antiemetics		2 hours postoperatively
Secondary	Number of Participants Requiring Antiemetics		6 hours postoperatively
Secondary	Number of Participants Requiring Antiemetics		24 hours postoperatively
Secondary	Number of Participants Requiring Antiemetics		48 hours postoperatively
Secondary	Overall Satisfaction With Pain Control	Satisfaction Rating, with 0 being not at all satisfied and 10 being completely satisfied	1 week postoperatively