Pain
Conditions
Keywords
Surgical Pain Management, Robotic surgery, Ropivacaine
Brief summary
The purpose of this trial is to determine the effect of spraying a local anesthetic called Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a local anesthetic used to block pain in the body. There are studies showing that Ropivacaine decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder removal but has not been tried in robotic pelvic surgery.
Detailed description
Practice guidelines from the American Society of Anesthesiologists peri-operative techniques for pain management have remained essentially unchanged over the last 10 years (3). Current acute pain-management strategies include 1.) Epidural or intrathecal opioids 2.) Patient-controlled devices delivering systemic opioids and 3.) Regional techniques such as peripheral nerve blocks and post-incisional infiltration with local anesthetics. The use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay. The literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal. A recently published study describes the use of intraperitoneal Ropivacaine (2mh/kg) during laparoscopic appendectomy(4). The study was a randomized, double-blinded, placebo-controlled study using Ropivacaine (vs placebo) injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients(4). Patients treated with Ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo. There were no side-effects found with the one-time use of the Ropivacaine. The results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly. Hence this study was undertaken to investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery.
Interventions
DRUGIntraperitoneal Ropivacaine (AIR)
Ropivacaine 2 mg/kg per lean body mass up to no more than 200mg total dose will be atomized and delivered into the peritoneal cavity at the completion of surgery.
DRUGAtomized Intraperitoneal Saline (AIS)
Atomized saline will be administered to the peritoneal cavity at the completion of surgery.
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Consent to undergo robotic assisted gynecologic or urologic surgery * Between the ages of 18 and 75 * Able to consent, fill out study documents, and complete all study procedures and follow-up visits
Exclusion criteria
* Patients with an allergy to local anesthetics * Patients with severe underlying cardiovascular, renal or hepatic disease * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR) | 2 hours after surgery | Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR) | 12 hours after surgery | Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100. |
Countries
United States
Participant flow
Recruitment details
Women undergoing minimally invasive laparoscopic surgery in urogynecology, benign gynecology, and gynecologic-oncology clinics were recruited. All women who were scheduled to undergo a minimally invasive hysterectomy for benign and cancerous conditions between February 2012 and March 2013 were invited to participate.
Pre-assignment details
One enrolled participant was excluded from the trial before assignment to groups because her physician prescribed Ropivacaine and, consequently, the participant was converted to open label before study drug was assigned or administered.
Participants by arm
| Arm | Count |
|---|---|
| Intraperitoneal Ropivacaine(AIR) Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery. | 25 |
| Atomized Intraperitoneal Saline (AIS) Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery. | 30 |
| Total | 55 |
Baseline characteristics
| Characteristic | Atomized Intraperitoneal Saline (AIS) | Intraperitoneal Ropivacaine(AIR) | Total |
|---|---|---|---|
| Age, Continuous | 58.8 years | 54.6 years | 56.9 years |
| Attending Specialty Benign Gynecology | 4 participants | 2 participants | 6 participants |
| Attending Specialty Gynecologic Oncology | 12 participants | 11 participants | 23 participants |
| Attending Specialty Urogynecology | 14 participants | 12 participants | 26 participants |
| Length of Hospital Stay 24 to 48 hours | 23 participants | 19 participants | 42 participants |
| Length of Hospital Stay Greater than 48 hours | 7 participants | 6 participants | 13 participants |
| Length of Hospital Stay Less than 24 hours | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black | 5 participants | 2 participants | 7 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized White | 22 participants | 21 participants | 43 participants |
| Sex: Female, Male Female | 30 Participants | 25 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgical Approach Laparoscopic | 11 participants | 11 participants | 22 participants |
| Surgical Approach Robotic | 19 participants | 14 participants | 33 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 30 |
| serious Total, serious adverse events | 0 / 25 | 0 / 30 |
Outcome results
Primary
Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)
Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.
Time frame: 2 hours after surgery
Population: All individuals randomized are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Ropivacaine(AIR) | Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR) | 2.536 millimeters | Standard Deviation 2.7 |
| Atomized Intraperitoneal Saline (AIS) | Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR) | 3.844 millimeters | Standard Deviation 3 |
Comparison: The null hypothesis is that the mean VAS score 2 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).p-value: 0.09895% CI: [-2.83, 0.214]t-test, 2 sided
Secondary
Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)
Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.
Time frame: 12 hours after surgery
Population: All individuals randomized are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Ropivacaine(AIR) | Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR) | 2.154 millimeters | Standard Deviation 1.9 |
| Atomized Intraperitoneal Saline (AIS) | Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR) | 2.219 millimeters | Standard Deviation 2 |
Comparison: The null hypothesis is that the mean VAS score 12 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).p-value: 0.995% CI: [-1.103, 0.973]t-test, 2 sided