Pain, PostoperativeNCT02314104
Efficacy of Transversus Abdominis Plane Block Versus Local Injection of Pain Medication
A study testing ropivacaine in people with Pain, Postoperative, run by Liberman, Eric, D.O. at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is a better method of administering pain medication prior to minimally invasive gynecological surgery so that postoperative pain and/or narcotic usage may be minimized. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Undergoing gynecological robotic and/or laparoscopic surgery
- Overnight hospitalization expected
Who cannot join
- Fibromyalgia
- Chronic pelvic pain
- Relevant drug allergy
- Conversion to laparotomy
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
About this study
Official title: Analgesic Efficacy of Transversus Abdominis Plane Block Versus Local Injection in Postoperative Pain Management Following Minimally Invasive Gynecological Surgery
The purpose of this study is to determine if there is a better method of administering pain medication prior to minimally invasive gynecological surgery so that postoperative pain and/or narcotic usage may be minimized. Currently, no standard of care exists regarding the use of local pain medications in minimally invasive gynecological surgery and practices vary widely among physicians, even within the same institution.
The two methods of preemptive pain medication that this study will be looking at is the transversus abdominis plane (TAP) block and the local injection of pain medication at the areas of the skin incisions. TAP block is a procedure performed by a specially trained pain management anesthesiologist in which there is an injection of a local pain medication into the abdominal wall, specifically in a space where the nerves that are responsible for postoperative pain reside. This procedure blocks the ability of the nerves to sense pain and has been found to be successful in decreasing postoperative pain in a number of procedures. The local injection of pain medications at the incision sites has also been found to be beneficial in decreasing postoperative pain. However, it is not known whether one method is superior to the other in decreasing postoperative pain or if the combination of both is best.
Read more
Patients that chose to participate are randomly (by chance) assigned to one of three groups: 1) TAP block with pain medication and local injection of normal saline (water) at the incision sites 2) TAP block with normal saline and local injection of pain medication at the incision sites or 3) TAP block with pain medication and local injection of pain medication at the port sites. These procedures are performed while the patient is asleep. Patients will be asked to record their level of pain on a standardized pain scale at one hour, six hours, and twenty-four hours after the surgery. All patients are provided with standard postoperative pain medications as needed.
The hypothesis is that patients receiving both TAP block and local injection of pain medication at the port sites will have less pain postoperatively and require a smaller amount of narcotics than those that receive either the TAP block or local injection of pain medication alone.
Read the detailed description
This is a prospective, single center, double-blinded, multi-arm parallel group study conducted at a university affiliated medical center. Study approval was obtained from the Saint Barnabas Medical Center institutional review board, and written informed consent was obtained from all study participants.
Patients were randomly assigned to one of three parallel groups in a 1:1:1 ratio, to receive either: treatment transversus abdominis plane (TAP) block and placebo local injection, placebo TAP block and treatment local injection, or treatment TAP block and treatment local injection. This study took place at Saint Barnabas Medical Center in Livingston, New Jersey from May 2011 to October 2013. Patients were recruited from the offices of ten different gynecological surgeons in private practice. Two of the surgeons were gynecological oncologists, and the remainder were general obstetricians/gynecologists that perform minimally invasive gynecological surgery. The TAP blocks were administered by one of four anesthesiologists.
Patients were consented and enrolled in the study by blinded obstetrical and gynecological residents while the patients were in the preoperative area. Each patient was given a standardized informed consent packet detailing the study. Once a patient gave informed consent and was enrolled in the study, independent pharmacists were notified of their enrollment. The pharmacists then assigned participants to one of three possible interventions based on a computer-generated randomization list that was created by the principal investigator prior to commencement of patient enrollment. The pharmacist assigned patients into their appropriate intervention based upon what number participant the patient was in the study. The pharmacist then dispensed the study medications into identical 30 mL syringes labeled study drug and placed them in brown paper bags. The study medication to be administered via TAP block was placed in two 30 mL syringes and placed in a brown paper bag. The study medication to be used for local injection was placed in a single 30 mL syringe and placed in a separate brown paper bag. These bags were then brought to the operating room where they were to be administered. The bag containing the two syringes was given to the anesthesiologists performing the TAP block and the bag with the single syringe was handed to the scrub tech that then later distributed it to the surgeons. The patients, all healthcare providers, and data collectors were blinded as to group allocation. Additionally, both ropivacaine and normal saline are clear and indistinguishable from one another.
The interventions were administered in the operating room once the patients had been placed under general anesthesia, prior to skin incisions. The TAP blocks were administered under ultrasound guidance.
Patients were then prepped and draped for surgery. Prior to proceeding to skin incisions the surgeons administered 2 mL of local injection subcutaneously at the intended port site locations. If additional port sites were deemed necessary during the procedure study drug was administered in a similar fashion prior to those skin incisions being made.
Postoperatively all patients received a standardized analgesia regimen. Specifically, for mild pain, oxycodone/acetaminophen 5/325 mg one tablet orally every four hours; for moderate pain, oxycodone/acetaminophen 5/325 mg two tablets orally every six hours, and for severe pain, hydromorphone 1 mg every 3 hours intravenously.
- Conditions
- Pain, Postoperative
- Being tested
- ropivacaine
- Keywords
- Surgical procedures, Minimally invasive, Nerve block, Anesthetics, Local
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called Naropin
Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment TAP, placebo local injection | Active comparator | Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. Receives: Drug: ropivacaine |
| Placebo TAP, treatment local injection | Active comparator | Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Receives: Drug: ropivacaine |
| Treatment TAP, treatment local injection | Active comparator | Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively
A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.
Measured: one hour postoperatively
Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively
A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.
Measured: six hours postoperatively
Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively
A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.
Measured: twenty-four hours postoperatively
Secondary outcomes (2)
Time Until First Request for Pain Medication
Measured: up to twenty-four hours postoperatively
Total Narcotic Usage in Morphine Equivalents
Measured: up to twenty-four hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberman, Eric, D.O.
- Responsible party
- Sponsor
- Investigators
- Eric C Liberman, D.O., Principal investigator, St. Barnabas Medical CenterThad Denehy, M.D., Principal investigator, St. Barnabas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314104
- Sponsor's protocol ID
- 11-02
- Status last verified
- Apr 2015
- First submitted
- 8 Dec 2014
- Last updated
- 14 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
PubMed 19020158El Hachem L, Small E, Chung P, Moshier EL, Friedman K, Fenske SS, Gretz HF 3rd. Randomized controlled double-blind trial of transversus abdominis plane block versus trocar site infiltration in gynecologic laparoscopy. Am J Obstet Gynecol. 2015 Feb;212(2):182.e1-9. doi: 10.1016/j.ajog.2014.07.049. Epub 2014 Aug 1.
PubMed 25088860Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
PubMed 18020088Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.
PubMed 22840413Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
PubMed 11576144
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Transversus Abdominis Plane Block Versus Local Injection in Postoperative Pain Management Following Minimally Invasive Gynecological Surgery
- ClinicalTrials.gov ID
- NCT02314104
- Acronym / sponsor ID
- 11-02
- Conditions
- Pain, Postoperative
- Keywords
- Surgical procedures, Minimally invasive, Nerve block, Anesthetics, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Liberman, Eric, D.O.
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Posted 14 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if there is a better method of administering pain medication prior to minimally invasive gynecological surgery so that postoperative pain and/or narcotic usage may be minimized. Currently, no standard of care exists regarding the use of local pain medications in minimally invasive gynecological surgery and practices vary widely among physicians, even within the same institution.
The two methods of preemptive pain medication that this study will be looking at is the transversus abdominis plane (TAP) block and the local injection of pain medication at the areas of the skin incisions. TAP block is a procedure performed by a specially trained pain management anesthesiologist in which there is an injection of a local pain medication into the abdominal wall, specifically in a space where the nerves that are responsible for postoperative pain reside. This procedure blocks the ability of the nerves to sense pain and has been found to be successful in decreasing postoperative pain in a number of procedures. The local injection of pain medications at the incision sites has also been found to be beneficial in decreasing postoperative pain. However, it is not known whether one method is superior to the other in decreasing postoperative pain or if the combination of both is best.
Patients that chose to participate are randomly (by chance) assigned to one of three groups: 1) TAP block with pain medication and local injection of normal saline (water) at the incision sites 2) TAP block with normal saline and local injection of pain medication at the incision sites or 3) TAP block with pain medication and local injection of pain medication at the port sites. These procedures are performed while the patient is asleep. Patients will be asked to record their level of pain on a standardized pain scale at one hour, six hours, and twenty-four hours after the surgery. All patients are provided with standard postoperative pain medications as needed.
The hypothesis is that patients receiving both TAP block and local injection of pain medication at the port sites will have less pain postoperatively and require a smaller amount of narcotics than those that receive either the TAP block or local injection of pain medication alone.
Detailed description
This is a prospective, single center, double-blinded, multi-arm parallel group study conducted at a university affiliated medical center. Study approval was obtained from the Saint Barnabas Medical Center institutional review board, and written informed consent was obtained from all study participants.
Patients were randomly assigned to one of three parallel groups in a 1:1:1 ratio, to receive either: treatment transversus abdominis plane (TAP) block and placebo local injection, placebo TAP block and treatment local injection, or treatment TAP block and treatment local injection. This study took place at Saint Barnabas Medical Center in Livingston, New Jersey from May 2011 to October 2013. Patients were recruited from the offices of ten different gynecological surgeons in private practice. Two of the surgeons were gynecological oncologists, and the remainder were general obstetricians/gynecologists that perform minimally invasive gynecological surgery. The TAP blocks were administered by one of four anesthesiologists.
Patients were consented and enrolled in the study by blinded obstetrical and gynecological residents while the patients were in the preoperative area. Each patient was given a standardized informed consent packet detailing the study. Once a patient gave informed consent and was enrolled in the study, independent pharmacists were notified of their enrollment. The pharmacists then assigned participants to one of three possible interventions based on a computer-generated randomization list that was created by the principal investigator prior to commencement of patient enrollment. The pharmacist assigned patients into their appropriate intervention based upon what number participant the patient was in the study. The pharmacist then dispensed the study medications into identical 30 mL syringes labeled study drug and placed them in brown paper bags. The study medication to be administered via TAP block was placed in two 30 mL syringes and placed in a brown paper bag. The study medication to be used for local injection was placed in a single 30 mL syringe and placed in a separate brown paper bag. These bags were then brought to the operating room where they were to be administered. The bag containing the two syringes was given to the anesthesiologists performing the TAP block and the bag with the single syringe was handed to the scrub tech that then later distributed it to the surgeons. The patients, all healthcare providers, and data collectors were blinded as to group allocation. Additionally, both ropivacaine and normal saline are clear and indistinguishable from one another.
The interventions were administered in the operating room once the patients had been placed under general anesthesia, prior to skin incisions. The TAP blocks were administered under ultrasound guidance.
Patients were then prepped and draped for surgery. Prior to proceeding to skin incisions the surgeons administered 2 mL of local injection subcutaneously at the intended port site locations. If additional port sites were deemed necessary during the procedure study drug was administered in a similar fashion prior to those skin incisions being made.
Postoperatively all patients received a standardized analgesia regimen. Specifically, for mild pain, oxycodone/acetaminophen 5/325 mg one tablet orally every four hours; for moderate pain, oxycodone/acetaminophen 5/325 mg two tablets orally every six hours, and for severe pain, hydromorphone 1 mg every 3 hours intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment TAP, placebo local injection | Active comparator | Drug: ropivacaineTreatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. |
| Placebo TAP, treatment local injection | Active comparator | Drug: ropivacainePlacebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. |
| Treatment TAP, treatment local injection | Active comparator | Drug: ropivacaineTreatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Undergoing gynecological robotic and/or laparoscopic surgery
- Overnight hospitalization expected
Key exclusion criteria (5 listed)
- Fibromyalgia
- Chronic pelvic pain
- Relevant drug allergy
- Conversion to laparotomy
- Pregnant
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 |
|---|---|---|
| ropivacaineAlso: NaropinTreatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. | Drug | Placebo TAP, treatment local injection, Treatment TAP, placebo local injection, Treatment TAP, treatment local injection |
Primary outcome
Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively
Time frame: one hour postoperatively
A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.
Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively
Time frame: six hours postoperatively
A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.
Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively
Time frame: twenty-four hours postoperatively
A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.
2 secondary outcomes
Time Until First Request for Pain Medication
Time frame: up to twenty-four hours postoperatively
Total Narcotic Usage in Morphine Equivalents
Time frame: up to twenty-four hours postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19020158Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Background: PubMed 25088860El Hachem L, Small E, Chung P, Moshier EL, Friedman K, Fenske SS, Gretz HF 3rd. Randomized controlled double-blind trial of transversus abdominis plane block versus trocar site infiltration in gynecologic laparoscopy. Am J Obstet Gynecol. 2015 Feb;212(2):182.e1-9. doi: 10.1016/j.ajog.2014.07.049. Epub 2014 Aug 1.
- Background: PubMed 18020088Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
- Background: PubMed 22840413Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.
- Background: PubMed 11576144Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
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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.
Eric C Liberman, D.O. principal investigator
St. Barnabas Medical Center
Thad Denehy, M.D. principal investigator
St. Barnabas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine in people with Pain, Postoperative, run by Liberman, Eric, D.O. at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively (time frame: one hour postoperatively). The study lists 3 primary outcomes in all. 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 NCT02314104, which also lists 5 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 14 Apr 2015.