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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how varying gas pressure levels during laparoscopic surgery impact postoperative pain and surgical visibility. It will test two pain relief treatments: bupivacaine (a local anesthetic) and oxycodone (an opioid pain medication), alongside different pressure settings. The trial includes groups based on pressure levels: low, standard, and lowest, with some surgeries assisted by robots. Individuals undergoing laparoscopic surgery at Cedars-Sinai Medical Center, who do not have an allergy to the pain medications, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially enhance surgical outcomes for future patients.

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 prior data suggests that varying gas pressure levels for laparoscopic surgery is safe?

Research has shown that using low gas pressure during keyhole surgery is safe and can reduce minor postoperative issues. Patients who underwent surgeries with abdominal pressure below 10 mmHg experienced less pain and had shorter hospital stays compared to those with higher pressure.

For surgeries using robotic assistance, studies indicate that maintaining pressure between 8-10 mmHg is safe and does not increase complications. Additionally, research suggests that pressures around 12 mmHg in robotic-assisted surgery can aid faster recovery without added risks.

Overall, lower pressure levels during keyhole surgeries, whether performed traditionally or with robotic assistance, appear well-tolerated and can enhance patient outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different gas pressure levels in laparoscopic surgery, potentially improving patient outcomes. Unlike standard procedures that typically use a specific pressure, this study investigates whether lower pressures, both in conventional and robotic-assisted laparoscopic surgery, can reduce post-operative pain and enhance recovery. By incorporating treatments like Bupivacaine and Oxycodone, the trial also aims to determine the ideal pressure settings that might minimize the need for pain medications, offering a more comfortable and efficient surgical experience.

What evidence suggests that this trial's treatments could be effective for post-operative pain and surgical field visualization in laparoscopic surgery?

This trial will compare different gas pressure levels for laparoscopic surgery, including both conventional and robotic-assisted approaches. Research has shown that using lower gas pressure during keyhole surgery can reduce pain and complications post-operation. Specifically, studies have found that using low pressure, around 10 mmHg, in these surgeries results in less pain and fewer issues afterward. For robot-assisted surgeries, low pressure also appears effective without increasing risk. In both types of surgery, lower pressure might lead to a quicker and more comfortable recovery. Overall, these findings suggest that lower pressure could be a safer and more comfortable choice for patients undergoing these surgeries. ^{2 6 7 8 9}

Who Is on the Research Team?

Matthew Siedhoff, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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 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 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 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]

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