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Transverse Abdominis Plane (TAP) Block After Cesarean Delivery

Primary Purpose

Postoperative Pain, Pregnancy, Obesity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
0.9% Normal Saline
0.2% Ropivacaine
0.5% Ropivacaine
0.75% Ropivacaine
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Cesarean Delivery, Ropivicaine, TAP block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA II-III patient
  • > 18 years of age who is pregnant
  • presenting for a cesarean delivery via Pfannenstiel incision who is eligible to receive a spinal anesthetic with 0.75% bupivacaine and fentanyl and whose is not eligible to receive intrathecal morphine due to a BMI >40 kg/m2.

Exclusion Criteria:

  • < 18 years of age
  • contraindication to placement of a spinal anesthetic
  • contraindication to use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • patients receiving medical therapies considered to result in tolerance to opioids
  • patients with a history of established chronic pain, (e.g. chronic low back pain, fibromyalgia or headaches), defined as requiring regular medical follow-up with pain specialists, as well as recent use (within the year preceding pregnancy) of opioid analgesics as an outpatient
  • patients with a history of diabetes mellitus
  • patients undergoing a vertical midline skin incision
  • patients who are undergoing a cesarean delivery after a failed vaginal trial of labor
  • patients who had a prior epidural placed for labor analgesia during the same hospital encounter.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

TAP Block utilizing 15mL of 0.9% normal saline per side

TAP Block utilizing 15ml of 0.2% ropivacaine per side

TAP Block utilizing 15ml of 0.5% ropivacaine per side

TAP Block utilizing 15ml of 0.75% ropivacaine per side

Outcomes

Primary Outcome Measures

Morphine Equivalents 0-24 Hours (Mgs)
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-24 hours after completion of the TAP block.

Secondary Outcome Measures

Morphine Equivalents 24-72 Hours (Mgs)
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 24-72 hours after completion of the TAP block.
Morphine Equivalents Total (Mgs)
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-72 hours after completion of the TAP block.
Time to First PCA Request
The elapsed time in minutes of the first PCA (patient controlled analgesia) request in time (minutes) from the end of the TAP block.
Pain Scores at Rest
Pain scores at rest ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the following hour time points, at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia).
Pain Scores With Movement
Pain scores with movement ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia).
Pain Burden at Rest
Pain burden at rest calculated as area under the pain score * time (hr) curve 0-72 hours.
Pain Burden With Movement
Pain burden with movement calculated as area under the pain score * time (hr) curve 0-72 hours.

Full Information

First Posted
July 23, 2010
Last Updated
December 7, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01170702
Brief Title
Transverse Abdominis Plane (TAP) Block After Cesarean Delivery
Official Title
The Postoperative Analgesic Efficacy of Varied Concentrations of Ropivacaine Used for the Transverse Abdominis Plane (TAP) Block After Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Since there have been no published dose-response studies investigating the effective analgesic dose of ropivacaine for use in a TAP block for post-Cesarean delivery analgesia, the investigators propose a study primarily examining the effect on 24 hour post-Cesarean delivery opioid consumption of using either a placebo, 0.25% ropivacaine, 0.5% ropivacaine, or 0.75% ropivacaine for TAP blocks.
Detailed Description
Cesarean delivery is the most commonly performed surgical procedure in the United States today, with over 1.2 million cases performed in 2005. One of the most important aspects of cesarean delivery is the provision of safe, effective postoperative analgesia for the mother, while simultaneously ensuring minimal side effects for both the mother and neonate. Studies have suggested that a multimodal approach to post-cesarean pain utilizing both intravenous, oral, and neuraxial opioids and non-steroidal anti-inflammatory drugs is highly effective in providing effective analgesia. A significant component of post-cesarean pain is incisional pain from the Pfannenstiel incision on the anterior abdominal wall. The sensory supply to the skin, muscles, and parietal peritoneum of the anterior abdominal wall is derived from the anterior rami of T7-L1. After exiting the spinal column, these nerves proceed through the lateral abdominal wall within the transversus abdominal fascial plane, terminating in the anterior abdominal wall. Recent studies have suggested that blocking these afferent sensory nerves with local anesthetics, as part of a multimodal postoperative pain regimen, provides superior pain relief in terms of decreased pain scores and morphine consumption for up to 48 hours postoperatively. The technique utilized for these studies employed a surface anatomical approach to the transversus abdominal fascial plane via the lumbar triangle of Petit, a technique validated in both cadaveric and radiologic studies. However, as ultrasonography has emerged as the "gold standard" for initiating many nerve blocks, reports have described the successful use of ultrasound imaging for initiation of transversus abdominis plane (TAP) blocks for both abdominal surgeries and cesarean deliveries. In the published studies investigating the use of the TAP block for post-operative analgesia, either ropivacaine or bupivacaine was utilized in concentrations of 0.75% and 0.375%, respectively. Studies comparing ropivacaine with bupivacaine for use in interscalene, femoral, or sciatic nerve blocks have found no difference in terms of potency, time to onset or duration of postoperative analgesia between the two local anesthetics. Although no similar studies have been done with TAP blocks, one can assume that utilization of ropivacaine for this nerve block would yield similar results in terms postoperative analgesia. Moreover, the cardiotoxicity of ropivacaine has been shown to be significantly less than bupivacaine, making it a safer alternative for use in nerve blocks when used in high doses. Risk factors for respiratory depression after the administration of neuraxial opioids in the non-obstetric population include morbid obesity and obstructive sleep apnea. For the obstetric population, a study of 856 patients revealed that all 8 patients who experienced respiratory depression after intrathecal morphine for cesarean delivery were markedly obese. Furthermore, the onset of respiratory depression after intrathecal morphine can occur up to 12 hours after administration, a time period when the patient is not being as closely monitored as she is during the 1:1 nursing care in the recovery room. Therefore, it is the investigators policy on the Labor and Delivery unit to not administer intrathecal morphine to any parturient with a history of obstructive sleep apnea or a BMI > 40 kg/m2. These patients often require intravenous opioid patient-controlled analgesia postoperatively, which has been shown to provide inferior pain relief and greater opioid consumption than neuraxial opioids. The current clinical standard is to administer the TAP block to those patients who have not received morphine in their neuraxial anesthetic. The TAP block offers a novel addition to the management of post-cesarean pain for this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Pregnancy, Obesity
Keywords
Cesarean Delivery, Ropivicaine, TAP block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
TAP Block utilizing 15mL of 0.9% normal saline per side
Arm Title
Group 2
Arm Type
Experimental
Arm Description
TAP Block utilizing 15ml of 0.2% ropivacaine per side
Arm Title
Group 3
Arm Type
Experimental
Arm Description
TAP Block utilizing 15ml of 0.5% ropivacaine per side
Arm Title
Group 4
Arm Type
Experimental
Arm Description
TAP Block utilizing 15ml of 0.75% ropivacaine per side
Intervention Type
Drug
Intervention Name(s)
0.9% Normal Saline
Intervention Description
The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
Intervention Type
Drug
Intervention Name(s)
0.2% Ropivacaine
Intervention Description
The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
Intervention Type
Drug
Intervention Name(s)
0.5% Ropivacaine
Intervention Description
The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
Intervention Type
Drug
Intervention Name(s)
0.75% Ropivacaine
Intervention Description
The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
Primary Outcome Measure Information:
Title
Morphine Equivalents 0-24 Hours (Mgs)
Description
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-24 hours after completion of the TAP block.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Morphine Equivalents 24-72 Hours (Mgs)
Description
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 24-72 hours after completion of the TAP block.
Time Frame
24-72 hours
Title
Morphine Equivalents Total (Mgs)
Description
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-72 hours after completion of the TAP block.
Time Frame
72 hours
Title
Time to First PCA Request
Description
The elapsed time in minutes of the first PCA (patient controlled analgesia) request in time (minutes) from the end of the TAP block.
Time Frame
Elapsed time in minutes
Title
Pain Scores at Rest
Description
Pain scores at rest ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the following hour time points, at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia).
Time Frame
Request for first patient controlled analgesia then at 2,6,24,72 hours after initial PCA request
Title
Pain Scores With Movement
Description
Pain scores with movement ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia).
Time Frame
First PCA request then at 2,6,24,72 hours after first PCA request.
Title
Pain Burden at Rest
Description
Pain burden at rest calculated as area under the pain score * time (hr) curve 0-72 hours.
Time Frame
72 hours
Title
Pain Burden With Movement
Description
Pain burden with movement calculated as area under the pain score * time (hr) curve 0-72 hours.
Time Frame
72 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA II-III patient > 18 years of age who is pregnant presenting for a cesarean delivery via Pfannenstiel incision who is eligible to receive a spinal anesthetic with 0.75% bupivacaine and fentanyl and whose is not eligible to receive intrathecal morphine due to a BMI >40 kg/m2. Exclusion Criteria: < 18 years of age contraindication to placement of a spinal anesthetic contraindication to use of non-steroidal anti-inflammatory drugs (NSAIDs) patients receiving medical therapies considered to result in tolerance to opioids patients with a history of established chronic pain, (e.g. chronic low back pain, fibromyalgia or headaches), defined as requiring regular medical follow-up with pain specialists, as well as recent use (within the year preceding pregnancy) of opioid analgesics as an outpatient patients with a history of diabetes mellitus patients undergoing a vertical midline skin incision patients who are undergoing a cesarean delivery after a failed vaginal trial of labor patients who had a prior epidural placed for labor analgesia during the same hospital encounter.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Walega, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9495409
Citation
Cardoso MM, Carvalho JC, Amaro AR, Prado AA, Cappelli EL. Small doses of intrathecal morphine combined with systemic diclofenac for postoperative pain control after cesarean delivery. Anesth Analg. 1998 Mar;86(3):538-41. doi: 10.1097/00000539-199803000-00017.
Results Reference
background
PubMed Identifier
14710063
Citation
Lowder JL, Shackelford DP, Holbert D, Beste TM. A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage. Am J Obstet Gynecol. 2003 Dec;189(6):1559-62; discussion 1562. doi: 10.1016/j.ajog.2003.08.014.
Results Reference
background
PubMed Identifier
11464348
Citation
Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5. doi: 10.1053/rapm.2001.21828.
Results Reference
background
PubMed Identifier
18378742
Citation
Loos MJ, Scheltinga MR, Mulders LG, Roumen RM. The Pfannenstiel incision as a source of chronic pain. Obstet Gynecol. 2008 Apr;111(4):839-46. doi: 10.1097/AOG.0b013e31816a4efa.
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
17179269
Citation
McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
Results Reference
background
PubMed Identifier
16418039
Citation
O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available. Erratum In: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added].
Results Reference
background
PubMed Identifier
18211466
Citation
Walter EJ, Smith P, Albertyn R, Uncles DR. Ultrasound imaging for transversus abdominis blocks. Anaesthesia. 2008 Feb;63(2):211. doi: 10.1111/j.1365-2044.2007.05424.x. No abstract available.
Results Reference
background

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Transverse Abdominis Plane (TAP) Block After Cesarean Delivery

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