Postoperative PainTAP HYSNCT01074229
Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy
A study testing Drug .5% Ropivacaine and 20 cc of 0.25% ropivacaine in people with Postoperative Pain, run by Northwestern University at 1 site in United States.
Trial summary
The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Drug .5% Ropivacaine and 20 cc of 0.25% ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2010
- 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 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-64 years
- Surgery: Laparoscopic Hysterectomy surgery
- ASA status: I and II
- Fluent in English
Who cannot join
- History of allergy to local anesthetics
- History of chronic opioid use
- Pregnant patients
- BMI greater than 30
- Drop-out criteria:
- Patient or surgeon request
- Complications related to the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: The Effect of Pre-operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Laparoscopic Hysterectomy: a Prospective, Randomized, Blinded Study
The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery.
Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics.
Read more
Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%.
This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.
- Conditions
- Postoperative Pain
- Being tested
- Placebo, Drug .5% Ropivacaine, 20 cc of 0.25% ropivacaine
- Keywords
- Pain, Post Operative, Opioids, Laparoscopic, Surgery, Hysterectomy
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sterile normal saline
placebo injection
Drug .5% RopivacaineDrug
Also called .5% Ropivacaine
.5% ropivacaine 20 mls on each side of abdomen
20 cc of 0.25% ropivacaineDrug
Also called .25% ropivacaine
Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | sterile normal saline as placebo Receives: Drug: Placebo |
| Drug .5% Ropivacaine | Active comparator | Instillation of 20 cc of 0.5% ropivacaine Receives: Drug: Drug .5% Ropivacaine |
| 20 cc of 0.25% ropivacaine | Active comparator | Instillation of 20 cc of 0.25% ropivacaine Receives: Drug: 20 cc of 0.25% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR40 on the Day After Surgery
QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.
Measured: 1 day
Secondary outcomes (1)
24 Total Morphine Consumption
Total 24 total morphine consumption post operative.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionOct 2010
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 (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gildasio De Oliveira, Northwestern University
- Investigators
- Gildasio DeOliveira, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074229
- Sponsor's protocol ID
- STU00023440
- Acronym
- TAP HYS
- Status last verified
- Apr 2014
- First submitted
- 22 Feb 2010
- Last updated
- 8 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.
PubMed 16738152Babalola EO, Bharucha AE, Schleck CD, Gebhart JB, Zinsmeister AR, Melton LJ 3rd. Decreasing utilization of hysterectomy: a population-based study in Olmsted County, Minnesota, 1965-2002. Am J Obstet Gynecol. 2007 Mar;196(3):214.e1-7. doi: 10.1016/j.ajog.2006.10.390.
PubMed 17346525Lenz H, Sandvik L, Qvigstad E, Bjerkelund CE, Raeder J. A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. Anesth Analg. 2009 Oct;109(4):1279-83. doi: 10.1213/ane.0b013e3181b0f0bb.
PubMed 19762758Thiel JA, Kamencic H. Assessment of costs associated with outpatient total laparoscopic hysterectom. J Obstet Gynaecol Can. 2006 Sep;28(9):794-798. doi: 10.1016/S1701-2163(16)32258-7.
PubMed 17022920Lovatsis D, Jose JB, Tufman A, Drutz HP, Murphy K. Assessment of patient satisfaction with postoperative pain management after ambulatory gynaecologic laparoscopy. J Obstet Gynaecol Can. 2007 Aug;29(8):664-7. doi: 10.1016/s1701-2163(16)32552-x.
PubMed 17714620Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.
PubMed 10718794Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.
PubMed 10910857Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.
PubMed 11703235Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.
PubMed 9861124Keita H, Benifla JL, Le Bouar V, Porcher R, Wachowska B, Bedairia K, Mantz J, Desmonts JM. Prophylactic ip injection of bupivacaine and/or morphine does not improve postoperative analgesia after laparoscopic gynecologic surgery. Can J Anaesth. 2003 Apr;50(4):362-7. doi: 10.1007/BF03021033.
PubMed 12670813De Oliveira GS Jr, Milad MP, Fitzgerald P, Rahmani R, McCarthy RJ. Transversus abdominis plane infiltration and quality of recovery after laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1230-1237. doi: 10.1097/AOG.0b013e318236f67f.
PubMed 22105251
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Laparoscopic Hysterectomy: a Prospective, Randomized, Blinded Study
- ClinicalTrials.gov ID
- NCT01074229
- Acronym / sponsor ID
- TAP HYS / STU00023440
- Conditions
- Postoperative Pain
- Keywords
- Pain, Post Operative, Opioids, Laparoscopic, Surgery, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery.
Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics.
Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%.
This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebosterile normal saline as placebo |
| Drug .5% Ropivacaine | Active comparator | Drug: Drug .5% RopivacaineInstillation of 20 cc of 0.5% ropivacaine |
| 20 cc of 0.25% ropivacaine | Active comparator | Drug: 20 cc of 0.25% ropivacaineInstillation of 20 cc of 0.25% ropivacaine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-64 years
- Surgery: Laparoscopic Hysterectomy surgery
- ASA status: I and II
- Fluent in English
Key exclusion criteria (7 listed)
- History of allergy to local anesthetics
- History of chronic opioid use
- Pregnant patients
- BMI greater than 30
- Patient or surgeon request
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 |
|---|---|---|
| PlaceboAlso: Sterile normal salineplacebo injection | Drug | Placebo |
| Drug .5% RopivacaineAlso: .5% Ropivacaine.5% ropivacaine 20 mls on each side of abdomen | Drug | Drug .5% Ropivacaine |
| 20 cc of 0.25% ropivacaineAlso: .25% ropivacaineWill receive a bilateral TAP block using 20 cc of 0.25% ropivacaine | Drug | 20 cc of 0.25% ropivacaine |
Primary outcome
QoR40 on the Day After Surgery
Time frame: 1 day
QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.
1 secondary outcome
24 Total Morphine Consumption
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16738152Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.
- Background: PubMed 17346525Babalola EO, Bharucha AE, Schleck CD, Gebhart JB, Zinsmeister AR, Melton LJ 3rd. Decreasing utilization of hysterectomy: a population-based study in Olmsted County, Minnesota, 1965-2002. Am J Obstet Gynecol. 2007 Mar;196(3):214.e1-7. doi: 10.1016/j.ajog.2006.10.390.
- Background: PubMed 19762758Lenz H, Sandvik L, Qvigstad E, Bjerkelund CE, Raeder J. A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. Anesth Analg. 2009 Oct;109(4):1279-83. doi: 10.1213/ane.0b013e3181b0f0bb.
- Background: PubMed 17022920Thiel JA, Kamencic H. Assessment of costs associated with outpatient total laparoscopic hysterectom. J Obstet Gynaecol Can. 2006 Sep;28(9):794-798. doi: 10.1016/S1701-2163(16)32258-7.
- Background: PubMed 17714620Lovatsis D, Jose JB, Tufman A, Drutz HP, Murphy K. Assessment of patient satisfaction with postoperative pain management after ambulatory gynaecologic laparoscopy. J Obstet Gynaecol Can. 2007 Aug;29(8):664-7. doi: 10.1016/s1701-2163(16)32552-x.
- Background: PubMed 10718794Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.
- Background: PubMed 10910857Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.
- Background: PubMed 11703235Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.
- Background: PubMed 9861124Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.
- Background: PubMed 12670813Keita H, Benifla JL, Le Bouar V, Porcher R, Wachowska B, Bedairia K, Mantz J, Desmonts JM. Prophylactic ip injection of bupivacaine and/or morphine does not improve postoperative analgesia after laparoscopic gynecologic surgery. Can J Anaesth. 2003 Apr;50(4):362-7. doi: 10.1007/BF03021033.
- Derived from this study: PubMed 22105251De Oliveira GS Jr, Milad MP, Fitzgerald P, Rahmani R, McCarthy RJ. Transversus abdominis plane infiltration and quality of recovery after laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1230-1237. doi: 10.1097/AOG.0b013e318236f67f.
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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.
Gildasio DeOliveira, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug .5% Ropivacaine and 20 cc of 0.25% ropivacaine in people with Postoperative Pain, run by Northwestern University 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 4 inclusion and 7 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 8 May 2014. 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. Some participants in this study may receive a placebo. 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 8 May 2014). 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?
QoR40 on the Day After Surgery (time frame: 1 day). 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 NCT01074229, which also lists 11 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 8 May 2014; AzTrials last refreshed its copy on 1 Nov 2026.