Opioid-use DisorderPhase 4NCT04033562

The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

A Phase 4 study testing Lidocaine patch and Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr in people with Opioid-use Disorder and Opioid Use, run by WellSpan Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Read more about this study

Who is it for?: Ages 18 to 100 years, women onlyHealthy volunteers can take part
Conditions the study is for: Opioid-use Disorder, Opioid Use, Opioid Dependence
What is being tested?: Lidocaine patch and Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2020to 17 May 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Pregnancy
undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)

Who cannot join

Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
Non-English speaking
Allergy to bupivacaine, lidocaine, zinc, silver or menthol
Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
History of glucose-6-phosphate deficiency
Use of anti-arrhythmic drugs such as tocainide or mexiletine

Trial locations and contacts

1 site in 1 country.

United States1 site

WellSpan Health York Hospital
York, Pennsylvania, 17403

Other trials in United States

About this study

Read the detailed description

Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Conditions: Opioid-use Disorder, Opioid Use, Opioid Dependence, Opioid Abuse, Medication Assisted Treatment, Infusion Catheter, Wound
Being tested: Lidocaine patch, Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr
Medical subject headings: Opioid-Related Disorders, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine patchDrug
Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.
Ambu ACTion pump, 0.125% bupivacaine at 8cc/hrDevice
Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.

Study groups in NCT04033562
Study group	Role	What they receive
Lidoderm patch	Active comparator	Participants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours. Receives: Drug: Lidocaine patch
Infusion pump	Active comparator	Participants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively. Receives: Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain scores
Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being "no pain at all" and 10 being "the worst pain imaginable"
Measured: post-operative until 60 hours postpartum

Secondary outcomes (3)

Rescue opioid consumption
Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively
Measured: post-operative until 60 hours postpartum
Survey of nursing staff
1-item questionnaire to assess whether nursing felt that patient benefited from therapy. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)
Measured: between 48-60 hours post-Cesarean delivery
Patient survey
2-item questionnaire to assess whether patient felt like she benefited from therapy and whether she would elect to use it again in a future C-section. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)
Measured: between 48-60 hourrs post-Cesarean delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202017 May 2021

First posted26 Jul 2019
Study start15 Jan 2020
Primary completion17 May 2021
Study completion17 May 2021

Why it stopped: limited enrollment and unable to enroll subjects to reach statistical significance

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04033562
Sponsor's protocol ID: 1351850
Status last verified: Jun 2021
First submitted: 22 Jul 2019
Last updated: 7 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

Publications

Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94. doi: 10.1016/j.ijoa.2006.02.003.
PubMed 16798442
Fredman B, Shapiro A, Zohar E, Feldman E, Shorer S, Rawal N, Jedeikin R. The analgesic efficacy of patient-controlled ropivacaine instillation after Cesarean delivery. Anesth Analg. 2000 Dec;91(6):1436-40. doi: 10.1097/00000539-200012000-00025.
PubMed 11093995
Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002 Jun;186(6):1188-91. doi: 10.1067/mob.2002.122984.
PubMed 12066096
Kainu JP, Sarvela J, Halonen P, Puro H, Toivonen HJ, Halmesmaki E, Korttila KT. Continuous wound infusion with ropivacaine fails to provide adequate analgesia after caesarean section. Int J Obstet Anesth. 2012 Apr;21(2):119-24. doi: 10.1016/j.ijoa.2011.12.009. Epub 2012 Feb 16.
PubMed 22341892
Lalmand M, Wilwerth M, Fils JF, Van der Linden P. Continuous Ropivacaine Subfascial Wound Infusion Compared With Intrathecal Morphine for Postcesarean Analgesia: A Prospective, Randomized Controlled, Double-Blind Study. Anesth Analg. 2017 Sep;125(3):907-912. doi: 10.1213/ANE.0000000000001892.
PubMed 28368941
Jolly C, Jathieres F, Keita H, Jaouen E, Guyot B, Torre A. Cesarean analgesia using levobupivacaine continuous wound infiltration: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:125-30. doi: 10.1016/j.ejogrb.2015.08.023. Epub 2015 Aug 25.
PubMed 26366789
Guidelines for laparoscopic surgery during pregnancy. Society of American Gastrointestinal Endoscopic Surgeons (SAGES). Surg Endosc. 1998 Feb;12(2):189-90. No abstract available.
PubMed 9479743
Habib AS, Polascik TJ, Weizer AZ, White WD, Moul JW, ElGasim MA, Gan TJ. Lidocaine patch for postoperative analgesia after radical retropubic prostatectomy. Anesth Analg. 2009 Jun;108(6):1950-3. doi: 10.1213/ane.0b013e3181a21185.
PubMed 19448228
Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3.
PubMed 22861076
Khanna M, Peters C, Singh JR. Treating pain with the lidocaine patch 5% after total knee arthroplasty. PM R. 2012 Sep;4(9):642-6. doi: 10.1016/j.pmrj.2012.06.003. Epub 2012 Jul 28.
PubMed 22841969
Bajwa SJ, Kaur J. Clinical profile of levobupivacaine in regional anesthesia: A systematic review. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):530-9. doi: 10.4103/0970-9185.119172.
PubMed 24249993
Brower MC, Johnson ME. Adverse effects of local anesthetic infiltration on wound healing. Reg Anesth Pain Med. 2003 May-Jun;28(3):233-40. doi: 10.1053/rapm.2003.50050. No abstract available.
PubMed 12772142
Tam KW, Chen SY, Huang TW, Lin CC, Su CM, Li CL, Ho YS, Wang WY, Wu CH. Effect of wound infiltration with ropivacaine or bupivacaine analgesia in breast cancer surgery: A meta-analysis of randomized controlled trials. Int J Surg. 2015 Oct;22:79-85. doi: 10.1016/j.ijsu.2015.07.715. Epub 2015 Aug 12.
PubMed 26277531
Scott NB. Wound infiltration for surgery. Anaesthesia. 2010 Apr;65 Suppl 1:67-75. doi: 10.1111/j.1365-2044.2010.06241.x.
PubMed 20377548
Cobb B, Liu R, Valentine E, Onuoha O. Breastfeeding after Anesthesia: A Review for Anesthesia Providers Regarding the Transfer of Medications into Breast Milk. Transl Perioper Pain Med. 2015;1(2):1-7.
PubMed 26413558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis
ClinicalTrials.gov ID: NCT04033562
Acronym / sponsor ID: 1351850
Conditions: Opioid-use Disorder, Opioid Use, Opioid Dependence, Opioid Abuse, Medication Assisted Treatment, Infusion Catheter, Wound
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: limited enrollment and unable to enroll subjects to reach statistical significance
Enrolment: 2 participants (actual)
Lead sponsor: WellSpan HealthUniversity, hospital or other
Collaborators: Ambu A/S, York Opioid Collaborative, Pennsylvania
Study start: 15 Jan 2020 (actual)
Primary completion: 17 May 2021 (actual)
Study completion: 17 May 2021 (actual)
First posted: 26 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lidoderm patch	Active comparator	Drug: Lidocaine patchParticipants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours.
Infusion pump	Active comparator	Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hrParticipants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively.

Who may qualify

Ages: 18 to 100 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Pregnancy
undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)

Key exclusion criteria (6 listed)

Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
Non-English speaking
Allergy to bupivacaine, lidocaine, zinc, silver or menthol
Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
History of glucose-6-phosphate deficiency

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lidocaine patchLidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.	Drug	Lidoderm patch
Ambu ACTion pump, 0.125% bupivacaine at 8cc/hrInfusion pump will be placed at time of Cesarean delivery for post-operative pain control.	Device	Infusion pump

Primary outcome

Pain scores
Time frame: post-operative until 60 hours postpartum
Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being "no pain at all" and 10 being "the worst pain imaginable"

3 secondary outcomes

Rescue opioid consumption
Time frame: post-operative until 60 hours postpartum
Survey of nursing staff
Time frame: between 48-60 hours post-Cesarean delivery
Patient survey
Time frame: between 48-60 hourrs post-Cesarean delivery

Results and safety

The study was stopped early (reason given: limited enrollment and unable to enroll subjects to reach statistical significance). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
Background: PubMed 16798442Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94. doi: 10.1016/j.ijoa.2006.02.003.
Background: PubMed 11093995Fredman B, Shapiro A, Zohar E, Feldman E, Shorer S, Rawal N, Jedeikin R. The analgesic efficacy of patient-controlled ropivacaine instillation after Cesarean delivery. Anesth Analg. 2000 Dec;91(6):1436-40. doi: 10.1097/00000539-200012000-00025.
Background: PubMed 12066096Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002 Jun;186(6):1188-91. doi: 10.1067/mob.2002.122984.
Background: PubMed 22341892Kainu JP, Sarvela J, Halonen P, Puro H, Toivonen HJ, Halmesmaki E, Korttila KT. Continuous wound infusion with ropivacaine fails to provide adequate analgesia after caesarean section. Int J Obstet Anesth. 2012 Apr;21(2):119-24. doi: 10.1016/j.ijoa.2011.12.009. Epub 2012 Feb 16.
Background: PubMed 28368941Lalmand M, Wilwerth M, Fils JF, Van der Linden P. Continuous Ropivacaine Subfascial Wound Infusion Compared With Intrathecal Morphine for Postcesarean Analgesia: A Prospective, Randomized Controlled, Double-Blind Study. Anesth Analg. 2017 Sep;125(3):907-912. doi: 10.1213/ANE.0000000000001892.
Background: PubMed 26366789Jolly C, Jathieres F, Keita H, Jaouen E, Guyot B, Torre A. Cesarean analgesia using levobupivacaine continuous wound infiltration: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:125-30. doi: 10.1016/j.ejogrb.2015.08.023. Epub 2015 Aug 25.
Background: PubMed 9479743Guidelines for laparoscopic surgery during pregnancy. Society of American Gastrointestinal Endoscopic Surgeons (SAGES). Surg Endosc. 1998 Feb;12(2):189-90. No abstract available.
Background: PubMed 19448228Habib AS, Polascik TJ, Weizer AZ, White WD, Moul JW, ElGasim MA, Gan TJ. Lidocaine patch for postoperative analgesia after radical retropubic prostatectomy. Anesth Analg. 2009 Jun;108(6):1950-3. doi: 10.1213/ane.0b013e3181a21185.
Background: PubMed 22861076Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3.
Background: PubMed 22841969Khanna M, Peters C, Singh JR. Treating pain with the lidocaine patch 5% after total knee arthroplasty. PM R. 2012 Sep;4(9):642-6. doi: 10.1016/j.pmrj.2012.06.003. Epub 2012 Jul 28.
Background: PubMed 24249993Bajwa SJ, Kaur J. Clinical profile of levobupivacaine in regional anesthesia: A systematic review. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):530-9. doi: 10.4103/0970-9185.119172.
Background: PubMed 12772142Brower MC, Johnson ME. Adverse effects of local anesthetic infiltration on wound healing. Reg Anesth Pain Med. 2003 May-Jun;28(3):233-40. doi: 10.1053/rapm.2003.50050. No abstract available.
Bupivacaine hydrochlorideLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Burcher, MD principal investigator

WellSpan Health Ob-Gyn Residency Program Director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine patch and Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr in people with Opioid-use Disorder and Opioid Use, run by WellSpan Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: limited enrollment and unable to enroll subjects to reach statistical significance). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scores (time frame: post-operative until 60 hours postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04033562, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.