Gas Pressure Levels for Laparoscopic Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Matthew Siedhoff, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Opioids, Bupivacaine, Oxycodone, others

Disqualifiers: Pregnancy, Urgent surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you use opioids regularly, you cannot participate in this study.

What data supports the effectiveness of the drug Bupivacaine, Marcaine, Sensorcaine, Oxycodone, OxyContin, Roxicodone, Xtampza ER, Oxaydo, Tylox, Percodan, Percocet for laparoscopic surgery?

Research shows that using bupivacaine (Marcaine, Sensorcaine) as a local anesthetic can significantly reduce postoperative pain, and oxycodone is effective in managing acute postoperative pain, such as after laparoscopic surgeries. ^{1 2 3 4 5}

Is bupivacaine safe for use in humans?

Bupivacaine (also known as Marcaine or Sensorcaine) is generally considered safe for use in humans when used as a local anesthetic. Studies have shown it to be effective with minimal side effects in various surgical settings, including spinal anesthesia and postoperative pain relief, as long as recommended doses are followed. ^{3 6 7 8 9}

How does the treatment for gas pressure levels in laparoscopic surgery differ from other treatments?

The treatment for gas pressure levels in laparoscopic surgery is unique because it focuses on optimizing the pressure of gas used during the procedure, which can affect the relaxation of the abdominal wall and overall surgical conditions. This approach is different from traditional methods that primarily focus on anesthesia or muscle relaxants to achieve similar effects. ^{6 10 11 12 13}

Research Team

Matthew Siedhoff, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults over 18 who are scheduled for laparoscopic surgery with a gynecologic surgeon at Cedars-Sinai Medical Center. Participants must sign a consent form and agree to follow the study's procedures throughout its duration.

Inclusion Criteria

I am 18 years old or older.

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

I am currently using opioids for pain.

Pregnancy

I am scheduled to stay in the hospital after surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic gynecologic surgery with varying insufflation pressures (10mmHg, 12mmHg, 15mmHg) to assess post-operative pain and surgical field visualization

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for post-operative pain and adequacy of surgical field visualization

Postoperative day 0

1 visit (in-person)

Postoperative Monitoring

Participants' pain scores and opioid medication usage are assessed in the PACU

Postoperative day 0

Treatment Details

Interventions

• Bupivacaine (Local Anesthetic)
• Oxycodone (Opioid Analgesic)

Trial Overview The study is testing the effects of different insufflation pressures (how much gas is used to inflate the abdomen) on post-surgery pain and how well surgeons can see inside during laparoscopic surgery, using drugs like Bupivacaine and Oxycodone.

Participant Groups

Group I: 12mmHg (Robotic-Assisted Laparoscopic Arm) Experimental Treatment 3 Interventions

Lower Pressure, Robotic-Assisted Laparoscopic Arm

Group II: 12mmHg (Conventional Laparoscopic Arm) Experimental Treatment 3 Interventions

Lower Pressure, Conventional Laparoscopic Arm

Group III: 10mmHg (Robotic-Assisted Laparoscopic Arm) Experimental Treatment 3 Interventions

Lowest Pressure, Robotic-Assisted Laparoscopic Arm

Group IV: 10mmHg (Conventional Laparoscopic Arm) Experimental Treatment 3 Interventions

Lowest Pressure, Conventional Laparoscopic Arm

Group V: 15mmHg (Conventional Laparoscopic Arm) Active Control 3 Interventions

Standard Pressure, Conventional Laparoscopic Arm

Group VI: 15mmHg (Robotic-Assisted Laparoscopic Arm) Active Control 3 Interventions

Standard Pressure, Robotic-Assisted Laparoscopic Arm

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cedars-Sinai Medical Center Los Angeles, CA

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Patients Recruited

165,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targin®: An effective opiate analgesia with minimal gastrointestinal side effects-An observational study. Jones, S., Smith, M., Rossaak, J.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Modal Pain Control in Ambulatory Hand Surgery. Harrison, RK., DiMeo, T., Klinefelter, RD., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. Bourne, MH., Johnson, KA.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic concentrations of oxycodone--a prospective clinical PK/PD study in patients with laparoscopic cholecystectomy. Kokki, M., Broms, S., Eskelinen, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: bupivacaine compared with tetracaine. Moore, DC.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of bupivacaine after intraperitoneal administration to cats undergoing ovariohysterectomy. Benito, J., Monteiro, BP., Beaudry, F., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of intraperitoneal bupivacaine in laparoscopic bariatric surgery. Saafan, T., Abounozha, S., Obaid, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Epidural anesthesia with bupivacaine 0.75% for pelviscopic intervention. Clinical results of a 6-month study]. Wagner, F.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[O.15 mg Intrathecal buprenorphine applied for postoperative analgesia. A clinical double-blind study]. Lipp, M., Daubländer, M., Lanz, E.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analgesic effects of intraperitoneal and incisional bupivacaine with epinephrine after total abdominal hysterectomy. Ng, A., Swami, A., Smith, G., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anaesthesia with hyperbaric tetracaine: effect of age and body mass. Tuominen, M., Pitkänen, M., Doepel, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Targin®: An effective opiate analgesia with minimal gastrointestinal side effects-An observational study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Analgesic concentrations of oxycodone--a prospective clinical PK/PD study in patients with laparoscopic cholecystectomy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: bupivacaine compared with tetracaine. [2013]

7. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of bupivacaine after intraperitoneal administration to cats undergoing ovariohysterectomy. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of intraperitoneal bupivacaine in laparoscopic bariatric surgery. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Epidural anesthesia with bupivacaine 0.75% for pelviscopic intervention. Clinical results of a 6-month study]. [2013]

11. Germany pubmed.ncbi.nlm.nih.gov

[O.15 mg Intrathecal buprenorphine applied for postoperative analgesia. A clinical double-blind study]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

The analgesic effects of intraperitoneal and incisional bupivacaine with epinephrine after total abdominal hysterectomy. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Spinal anaesthesia with hyperbaric tetracaine: effect of age and body mass. [2019]