Gas Pressure Levels for Laparoscopic Surgery

Overseen By Rebekah Odum, BSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

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

Disqualifiers: Pregnancy, Urgent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Day of surgery

294 Participants Needed

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

Provision of signed and dated informed consent form

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

I am scheduled for a laparoscopic surgery at Cedars-Sinai with a specialized surgeon.

Exclusion Criteria

I am currently using opioids for pain.

Pregnancy

I am scheduled to stay in the hospital after surgery.

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
• Oxycodone

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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

In a pilot study involving 32 patients undergoing major surgery, Targin® (a combination of oxycodone and naloxone) effectively managed pain, with average pain scores of 1 at rest and 4 during movement over 5 days post-surgery.

The study reported a low incidence of post-operative ileus (12.5%) and no serious adverse events, suggesting that Targin® is a safe option for pain management in the perioperative setting.

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]

In a study of 79 patients undergoing thumb carpometacarpal arthroplasty or distal radius ORIF, the combination of oxycodone, acetaminophen, and ketorolac showed a trend towards better postoperative pain control and reduced opioid usage compared to other regimens.

Although not statistically significant, the group receiving oxycodone, acetaminophen, and ketorolac experienced fewer complications, suggesting that this combination may enhance safety and efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Instilling 0.5% bupivacaine directly into the surgical wound before closure is a safe and effective method for significantly reducing postoperative foot pain.

This technique offers a practical alternative to oral narcotics and parenteral agents, minimizing side effects and the need for complex administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

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]

In a study of 23 adult patients undergoing laparoscopic cholecystectomy, the minimum effective concentration (MEC) of oxycodone for managing acute post-operative pain was found to be between 20-35 ng/mL, which is higher than previously suggested values.

The minimum effective analgesic concentration (MEAC) was determined to be between 45-50 ng/mL, indicating that higher oxycodone levels are necessary for effective pain relief after surgery, thus providing important insights for post-operative pain management.

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]

In a study of 435 patients, bupivacaine (0.75% in 8.25% dextrose) demonstrated superior efficacy compared to tetracaine for spinal anesthesia, with only one unsatisfactory anesthesia case in the bupivacaine group versus 19 in the tetracaine group for the lower dose.

Bupivacaine was found to be a safe and reliable option for spinal anesthesia, although tetracaine provided longer motor blockade; adding epinephrine to either anesthetic significantly extended their duration of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study involving 8 healthy cats undergoing ovariohysterectomy, intraperitoneal administration of bupivacaine did not result in any signs of toxicosis, indicating a safe profile for this method of administration.

The maximum plasma concentration of bupivacaine was reached approximately 30 minutes after administration, with a mean elimination half-life of about 4.79 hours, suggesting effective pharmacokinetics for potential pain management in cats.

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]

Intraperitoneal local bupivacaine administered during bariatric surgery significantly reduces pain scores post-operation, indicating its effectiveness in pain management.

The use of bupivacaine also decreases the need for postoperative pain medications, suggesting it can enhance recovery and comfort for patients after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 55 patients undergoing laparoscopy, epidural Bupivacaine 0.75% was effective in relaxing abdominal wall muscles, with significant differences in analgesia levels observed based on dosage and patient weight.

The study found that the upper limits of analgesia varied with the total dose of Bupivacaine and the age of the patients, indicating that both factors can influence the effectiveness of epidural anesthesia.

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]

In a study of 29 patients undergoing orthopedic procedures, the addition of intrathecal buprenorphine to isobaric spinal anesthesia significantly enhanced sensory blockade by three segments and improved postoperative pain relief for up to 8 hours compared to the control group.

While buprenorphine provided longer pain-free intervals (13 hours vs. 9 hours in the control group), it did not affect the overall need for postoperative analgesics, and there were no significant changes in blood pressure or major respiratory parameters, although respiratory rates were lower in the buprenorphine group.

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]

In a study of 46 patients undergoing total abdominal hysterectomy, the use of bupivacaine with epinephrine significantly reduced the need for morphine in the first 4 hours post-surgery, indicating effective pain management.

Patients receiving bupivacaine reported less pain on movement upon awakening compared to those receiving a placebo, demonstrating the efficacy of this analgesic approach.

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]

In a study of 60 patients aged 17 to 82, a 15 mg subarachnoid injection of hyperbaric tetracaine provided effective spinal analgesia, but the spread of analgesia did not correlate with age or body mass.

Almost half of the patients required additional analgesia during surgery, and significant drops in blood pressure were more common in patients over 50, indicating a need for careful monitoring in older patients.

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]