Transverse Abdominis Plane (TAP) Block After Cesarean Delivery

NCT01170702 | Completed Phase 4 Results

• 1 other identifier: STU00008429
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Pregnancy; Obesity

Keywords

Cesarean Delivery; Ropivicaine; TAP block

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (7)

• Morphine Equivalents 24-72 Hours (Mgs)

  24-72 hours

• Morphine Equivalents Total (Mgs)

  72 hours

• Time to First PCA Request

  Elapsed time in minutes

• Pain Scores at Rest

  Request for first patient controlled analgesia then at 2,6,24,72 hours after initial PCA request

• Pain Scores With Movement

  First PCA request then at 2,6,24,72 hours after first PCA request.

Study Arms (4)

Group 1

PLACEBO COMPARATOR

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

Drug: 0.9% Normal Saline

Group 2

EXPERIMENTAL

TAP Block utilizing 15ml of 0.2% ropivacaine per side

Drug: 0.2% Ropivacaine

Group 3

EXPERIMENTAL

TAP Block utilizing 15ml of 0.5% ropivacaine per side

Drug: 0.5% Ropivacaine

Group 4

EXPERIMENTAL

TAP Block utilizing 15ml of 0.75% ropivacaine per side

Drug: 0.75% Ropivacaine

Interventions

0.9% Normal Saline DRUG

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.

Group 1

0.2% Ropivacaine DRUG

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.

Group 2

0.5% Ropivacaine DRUG

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.

Group 3

0.75% Ropivacaine DRUG

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.

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 9495409 BACKGROUND

• 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.

  PMID: 14710063 BACKGROUND

• 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.

  PMID: 11464348 BACKGROUND

• 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.

  PMID: 18378742 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

• 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.

  PMID: 17179269 BACKGROUND

• 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.

  PMID: 16418039 BACKGROUND

• 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.

  PMID: 18211466 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Obesity

Interventions

Saline Solution; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

We did not evaluate TAP success by quantifying the area of cutaneous sensory blockade. We established baseline pain scores immediately prior to TAP blockade, although most blocks were performed with residual spinal blockade present.

Results Point of Contact

• Title: Edward Yaghmour
• Organization: Northwestern University Feinberg School of Medicine

edward.yaghmour@nm.org

312-695-0693

Study Officials

• David Walega, M.D.

  Northwestern University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 27, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 8, 2021
• Results First Posted: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)