Pelvic PainNCT04118777
Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery
A study testing Ropivacaine in people with Pelvic Pain and Endometriosis, run by University of Tennessee, Chattanooga.
Trial summary
This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Endometriosis, Pelvic Prolapse
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 30 Jul 2020
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing laparoscopic gynecologic surgery with either the traditional "straight stick" or robotic assisted techniques will be considered for eligibility. Eligible patients will include those with pelvic pain and endometriosis as well as those who present for pelvic floor reconstruction. Surgical procedures performed will include excision of endometriosis, lysis of adhesions, hysterectomy, bilateral or unilateral salpingo-oophorectomy, cystectomy, and pelvic reconstruction.
- Patients who are 18 years or older
- Patients who provide written surgical consent
- Patients who are capable and willing to follow up with surveys and complete pain and pill diaries
Who cannot join
- Patients who are unable or willing to provide consent and complete the follow up surveys and dairies
- Patients who are allergic to Ropivacaine
- Patients whose minimally invasive procedures were converted to laparotomies
About this study
Official title: Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery: A Randomized, Double-blind, Placebo-controlled Trial Comparing Continuous Intraperitoneal Infusion of Ropivacaine Versus Saline for Post-operative Pain Control
This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline.
Read the detailed description
This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline. After inclusion criteria are met and consents are obtained all patients will be sent home with a pain measurement, a pill diary to record the quantity of narcotic tablets taken, and a questionnaire nausea and vomiting symptoms.
After placement of the ON-Q pain pump the select-a-flow rate will be set to 6 mL/hr for all study participants. . All study participants will be provided with rescue pain medications as needed. If possible non-narcotic medications such as Tylenol and non-steroidal anti-inflammatory's will be utilized first. If pain persists narcotic medications will be provided. Oxycodone 5 mg will be utilized unless a patient reported allergy exists. All rescue narcotics utilized will be converted into morphine equivalents and documented. All patients will be discharged with Oxycodone 5 mg with 35 tablets which provides pain coverage for 7 days after surgery. In addition to Oxycodone all patients will be discharged with Sprix, a nasal non-steroidal anti-inflammatory medication, as well as Zofran and movantik, a medication for narcotic induced constipation. All patients will be instructed to administer Sprix by placing one puff into each nostril every 6 hours for a total of 5 days after surgery. They will further be instructed to take oral Tylenol 1000 mg every 6 hours for a total of 4 days after surgery. Assigned research personnel will contact all patients to obtain the results of their survey and pill dairy at 48 hours and one week after surgery. Patients will then present for a two-week post-operative visit where study personnel will complete data collection. All study participants who request a narcotic refill within 6 weeks of surgery will be documented.
- Conditions
- Pelvic Pain, Endometriosis, Pelvic Prolapse
- Being tested
- Ropivacaine
- Medical subject headings
- Pelvic Pain, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr
| Study group | Role | What they receive |
|---|---|---|
| 0.2 % Ropivacaine | Active comparator | An ON-Q pain pump will be placed into the pelvic cavity and 0.2% Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr. Receives: Drug: Ropivacaine |
| Saline | Placebo comparator | An ON-Q pain pump will be placed into the pelvic cavity and saline will be continuously administered intraperitoneally at a rate of 6 mL/hr Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of rescue narcotics consumed in the postoperative period, calculated as morphine equivalents.
All rescue oral narcotics taken in the post-operative period will be converted to morphine equivalents and recorded
Measured: 6 weeks after surgery
Secondary outcomes (3)
post-operative pain scores
Pain scores will be obtained via the visual analog scale (VAS). The VAS tool measures pain on a scale from 0 to 10 with 0 being no pain and 10 being unbearable pain.
Measured: 1,2, 4, and 48 hours after surgery. 1 and 2 weeks after surgery
nausea and vomiting
The postoperative nausea and vomiting impact scale will be used to measure the presence and amount of nausea and vomiting. The scale measures the amount of vomiting from 0 ( no vomiting) to 3 ( three or more episodes of vomiting). The second questions measures the presence of nausea and then the amount from o ( no nausea) to 3 ( all of the time).
Measured: 48 hours, 1 week, and 2 weeks after surgery
Hospital discharge
Time to discharge
Measured: post-operative day zero to two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 May 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Why it stopped: Misregistered to wrong sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee, Chattanooga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118777
- Sponsor's protocol ID
- 123
- Status last verified
- Jul 2021
- First submitted
- 1 Oct 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madsen AM, Stark LM, Has P, Emerson JB, Schulkin J, Matteson KA. Opioid Knowledge and Prescribing Practices Among Obstetrician-Gynecologists. Obstet Gynecol. 2018 Jan;131(1):150-157. doi: 10.1097/AOG.0000000000002407.
PubMed 29215508As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
PubMed 29112660Hota LS, Warda HA, Haviland MJ, Searle FM, Hacker MR. Opioid use following gynecologic and pelvic reconstructive surgery. Int Urogynecol J. 2018 Oct;29(10):1441-1445. doi: 10.1007/s00192-017-3474-5. Epub 2017 Sep 9.
PubMed 28889218Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
PubMed 28564673Perniola A, Fant F, Magnuson A, Axelsson K, Gupta A. Postoperative pain after abdominal hysterectomy: a randomized, double-blind, controlled trial comparing continuous infusion vs patient-controlled intraperitoneal injection of local anaesthetic. Br J Anaesth. 2014 Feb;112(2):328-36. doi: 10.1093/bja/aet345. Epub 2013 Oct 31.
PubMed 24185607Chung D, Lee YJ, Jo MH, Park HJ, Lim GW, Cho H, Nam EJ, Kim SW, Kim JH, Kim YT, Kim S. The ON-Q pain management system in elective gynecology oncologic surgery: Management of postoperative surgical site pain compared to intravenous patient-controlled analgesia. Obstet Gynecol Sci. 2013 Mar;56(2):93-101. doi: 10.5468/OGS.2013.56.2.93. Epub 2013 Mar 12.
PubMed 24327987Gupta A, Perniola A, Axelsson K, Thorn SE, Crafoord K, Rawal N. Postoperative pain after abdominal hysterectomy: a double-blind comparison between placebo and local anesthetic infused intraperitoneally. Anesth Analg. 2004 Oct;99(4):1173-1179. doi: 10.1213/01.ANE.0000130260.24433.A2.
PubMed 15385371Cottam DR, Fisher B, Atkinson J, Link D, Volk P, Friesen C, Link D, Grace B, Trovar R. A randomized trial of bupivicaine pain pumps to eliminate the need for patient controlled analgesia pumps in primary laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2007 May;17(5):595-600. doi: 10.1007/s11695-007-9103-5.
PubMed 17658017Yoost TR, McIntyre M, Savage SJ. Continuous infusion of local anesthetic decreases narcotic use and length of hospitalization after laparoscopic renal surgery. J Endourol. 2009 Apr;23(4):623-6. doi: 10.1089/end.2008.0586.
PubMed 19335329Thornton PC, Buggy DJ. Local anaesthetic wound infusion for acute postoperative pain: a viable option? Br J Anaesth. 2011 Nov;107(5):656-8. doi: 10.1093/bja/aer293. No abstract available.
PubMed 21997148Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal local anaesthetic in abdominal surgery - a systematic review. ANZ J Surg. 2011 Apr;81(4):237-45. doi: 10.1111/j.1445-2197.2010.05573.x. Epub 2010 Nov 17.
PubMed 21418466Williamson KM, Cotton BR, Smith G. Intraperitoneal lignocaine for pain relief after total abdominal hysterectomy. Br J Anaesth. 1997 Jun;78(6):675-7. doi: 10.1093/bja/78.6.675.
PubMed 9215018Lee SH, Sim WS, Kim GE, Kim HC, Jun JH, Lee JY, Shin BS, Yoo H, Jung SH, Kim J, Lee SH, Yo DK, Na YR. Randomized trial of subfascial infusion of ropivacaine for early recovery in laparoscopic colorectal cancer surgery. Korean J Anesthesiol. 2016 Dec;69(6):604-613. doi: 10.4097/kjae.2016.69.6.604. Epub 2016 Sep 28.
PubMed 27924202
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery: A Randomized, Double-blind, Placebo-controlled Trial Comparing Continuous Intraperitoneal Infusion of Ropivacaine Versus Saline for Post-operative Pain Control
- ClinicalTrials.gov ID
- NCT04118777
- Acronym / sponsor ID
- 123
- Conditions
- Pelvic Pain, Endometriosis, Pelvic Prolapse
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Misregistered to wrong sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Tennessee, ChattanoogaUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 8 Oct 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.
This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline.
Detailed description
This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline. After inclusion criteria are met and consents are obtained all patients will be sent home with a pain measurement, a pill diary to record the quantity of narcotic tablets taken, and a questionnaire nausea and vomiting symptoms.
After placement of the ON-Q pain pump the select-a-flow rate will be set to 6 mL/hr for all study participants. . All study participants will be provided with rescue pain medications as needed. If possible non-narcotic medications such as Tylenol and non-steroidal anti-inflammatory's will be utilized first. If pain persists narcotic medications will be provided. Oxycodone 5 mg will be utilized unless a patient reported allergy exists. All rescue narcotics utilized will be converted into morphine equivalents and documented. All patients will be discharged with Oxycodone 5 mg with 35 tablets which provides pain coverage for 7 days after surgery. In addition to Oxycodone all patients will be discharged with Sprix, a nasal non-steroidal anti-inflammatory medication, as well as Zofran and movantik, a medication for narcotic induced constipation. All patients will be instructed to administer Sprix by placing one puff into each nostril every 6 hours for a total of 5 days after surgery. They will further be instructed to take oral Tylenol 1000 mg every 6 hours for a total of 4 days after surgery. Assigned research personnel will contact all patients to obtain the results of their survey and pill dairy at 48 hours and one week after surgery. Patients will then present for a two-week post-operative visit where study personnel will complete data collection. All study participants who request a narcotic refill within 6 weeks of surgery will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.2 % Ropivacaine | Active comparator | Drug: RopivacaineAn ON-Q pain pump will be placed into the pelvic cavity and 0.2% Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr. |
| Saline | Placebo comparator | Drug: RopivacaineAn ON-Q pain pump will be placed into the pelvic cavity and saline will be continuously administered intraperitoneally at a rate of 6 mL/hr |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients undergoing laparoscopic gynecologic surgery with either the traditional "straight stick" or robotic assisted techniques will be considered for eligibility. Eligible patients will include those with pelvic pain and endometriosis as well as those who present for pelvic floor reconstruction. Surgical procedures performed will include excision of endometriosis, lysis of adhesions, hysterectomy, bilateral or unilateral salpingo-oophorectomy, cystectomy, and pelvic reconstruction.
- Patients who are 18 years or older
- Patients who provide written surgical consent
- Patients who are capable and willing to follow up with surveys and complete pain and pill diaries
Key exclusion criteria (3 listed)
- Patients who are unable or willing to provide consent and complete the follow up surveys and dairies
- Patients who are allergic to Ropivacaine
- Patients whose minimally invasive procedures were converted to laparotomies
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 |
|---|---|---|
| Ropivacaine0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr | Drug | 0.2 % Ropivacaine, Saline |
Primary outcome
Amount of rescue narcotics consumed in the postoperative period, calculated as morphine equivalents.
Time frame: 6 weeks after surgery
All rescue oral narcotics taken in the post-operative period will be converted to morphine equivalents and recorded
3 secondary outcomes
post-operative pain scores
Time frame: 1,2, 4, and 48 hours after surgery. 1 and 2 weeks after surgery
nausea and vomiting
Time frame: 48 hours, 1 week, and 2 weeks after surgery
Hospital discharge
Time frame: post-operative day zero to two
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Background: PubMed 29215508Madsen AM, Stark LM, Has P, Emerson JB, Schulkin J, Matteson KA. Opioid Knowledge and Prescribing Practices Among Obstetrician-Gynecologists. Obstet Gynecol. 2018 Jan;131(1):150-157. doi: 10.1097/AOG.0000000000002407.
- Background: PubMed 29112660As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
- Background: PubMed 28889218Hota LS, Warda HA, Haviland MJ, Searle FM, Hacker MR. Opioid use following gynecologic and pelvic reconstructive surgery. Int Urogynecol J. 2018 Oct;29(10):1441-1445. doi: 10.1007/s00192-017-3474-5. Epub 2017 Sep 9.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 28564673Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
- Background: PubMed 24185607Perniola A, Fant F, Magnuson A, Axelsson K, Gupta A. Postoperative pain after abdominal hysterectomy: a randomized, double-blind, controlled trial comparing continuous infusion vs patient-controlled intraperitoneal injection of local anaesthetic. Br J Anaesth. 2014 Feb;112(2):328-36. doi: 10.1093/bja/aet345. Epub 2013 Oct 31.
- Background: PubMed 24327987Chung D, Lee YJ, Jo MH, Park HJ, Lim GW, Cho H, Nam EJ, Kim SW, Kim JH, Kim YT, Kim S. The ON-Q pain management system in elective gynecology oncologic surgery: Management of postoperative surgical site pain compared to intravenous patient-controlled analgesia. Obstet Gynecol Sci. 2013 Mar;56(2):93-101. doi: 10.5468/OGS.2013.56.2.93. Epub 2013 Mar 12.
- Background: PubMed 15385371Gupta A, Perniola A, Axelsson K, Thorn SE, Crafoord K, Rawal N. Postoperative pain after abdominal hysterectomy: a double-blind comparison between placebo and local anesthetic infused intraperitoneally. Anesth Analg. 2004 Oct;99(4):1173-1179. doi: 10.1213/01.ANE.0000130260.24433.A2.
- Background: PubMed 17658017Cottam DR, Fisher B, Atkinson J, Link D, Volk P, Friesen C, Link D, Grace B, Trovar R. A randomized trial of bupivicaine pain pumps to eliminate the need for patient controlled analgesia pumps in primary laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2007 May;17(5):595-600. doi: 10.1007/s11695-007-9103-5.
- Background: PubMed 19335329Yoost TR, McIntyre M, Savage SJ. Continuous infusion of local anesthetic decreases narcotic use and length of hospitalization after laparoscopic renal surgery. J Endourol. 2009 Apr;23(4):623-6. doi: 10.1089/end.2008.0586.
- Background: PubMed 21997148Thornton PC, Buggy DJ. Local anaesthetic wound infusion for acute postoperative pain: a viable option? Br J Anaesth. 2011 Nov;107(5):656-8. doi: 10.1093/bja/aer293. No abstract available.
- Background: PubMed 21418466Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal local anaesthetic in abdominal surgery - a systematic review. ANZ J Surg. 2011 Apr;81(4):237-45. doi: 10.1111/j.1445-2197.2010.05573.x. Epub 2010 Nov 17.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Pelvic Pain and Endometriosis, run by University of Tennessee, Chattanooga.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Amount of rescue narcotics consumed in the postoperative period, calculated as morphine equivalents. (time frame: 6 weeks after surgery). 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 NCT04118777, which also lists 14 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 20 Jul 2021.