Genital Neoplasm Malignant FemalePhase 3NCT04202874
A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology
A Phase 3 study testing Surgeon-administered transversus abdominis plane (TAP) in people with Genital Neoplasm Malignant Female and Surgical Procedure, Unspecified, run by McMaster University at 1 site in Canada.
Trial summary
Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. Administration by the surgeon of local anesthetics in the abdominal wall after surgery for a suspected gynaecological malignancy will be studied. 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
- Genital Neoplasm Malignant Female, Surgical Procedure, Unspecified
- What is being tested?
- Surgeon-administered transversus abdominis plane (TAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients aged 18 and above undergoing elective gynecologic oncology surgery for a suspected malignancy using a midline laparotomy incision.
Who cannot join
- Patients unable to give informed consent
- Patients with contraindications or sensitivities to drugs specified in the protocol
- Pre-existing truncal sensory disturbance
- History of chronic opioid use (daily use > 3 months)
- Infections at the injection site
- Significant adhesions on the anterior abdominal wall preventing access to the injection site
- Concurrent, non-abdominal surgical procedure performed at the same time
- Patients receiving neuraxial anesthesia/analgesia (epidural, spinal) or local wound infiltration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded Randomized Trial Comparing Surgeon-administered Transversus Abdominis Plane (TAP) Block With Placebo After Midline Laparotomy in Gynecologic Oncology
Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. Administration by the surgeon of local anesthetics in the abdominal wall after surgery for a suspected gynaecological malignancy will be studied. Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be recruited. Half of these women will received a Transversus Abdominis Plane (TAP) block using local anesthetics, and half will receive a placebo (saline water). The primary outcome studied will be the total dose of opioid in morphine equivalents received in the postoperative period. The primary hypothesis is that surgeon-performed TAP blocks reduce the need for opioids after surgery. Secondary outcomes including postoperative pain scores, postoperative nausea and vomiting rates, time to flatus, incidence of clinical ileus and time to discharge from hospital will also be recorded.
Read the detailed description
Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. While ultrasound-guided Transversus Abdominis Plane (TAP) block has been shown to reduce postoperative opioid use, the time and expertise needed to perform it can be a barrier to administering the procedure. A surgeon-administered TAP block has been described, but has yet to be evaluated with a randomized controlled study in gynecology oncology patients undergoing a midline laparotomy. The investigators hypothesize that surgeon-administered TAP blocks may decrease total opioid use in the first 24 hours.
Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be recruited to undergo bilateral surgeon-administered TAP blocks with either 40ml of 0.25% bupivacaine or an equal volume of saline administered equally over both sides, prior to fascial closure. Exclusion criteria include inability to give informed consent, presence of contraindications or sensitivities to drugs specified in the protocol, pre-existing truncal sensory disturbance, history of chronic opioid use, infections at the injection site, significant adhesions on the anterior or lateral abdominal wall preventing access to the injection site, patients receiving neuraxial anesthesia (Epidural, Spinal) or local wound infiltration. The primary outcome studied will be the total dose of opioid in morphine equivalents received in the postoperative period. Secondary outcomes including postoperative pain scores, postoperative nausea and vomiting rates, time to flatus, incidence of clinical ileus and time to discharge from hospital will also be recorded.
Sample size calculation was based on a meta-analysis by Johns for use of TAP blocks in abdominal surgeries, that reported morphine equivalents mean at 24h as 20.6mg for the TAP group and 44.3mg for the control group (mean difference of 23mg in 24h), with a standard deviation of 14mg. To find a clinically significant decrease in opioid use of 20%, our primary outcome, with a 2-tailed analysis and power of 80%; the investigators would need 36 patients in each group. To account for potential dropouts and protocol violations, as well as secondary analyses, the investigators will recruit a total of 80 patients (40 in the TAP block group and 40 controls).
Differences in characteristics between treatment and control groups will be analysed using the chi-square test for dichotomous data, independent samples Student's t-test for parametric continuous variables, and Mann-Whitney U test for non-parametric continuous data. Test of normality will be performed using the Shapiro-Wilk test. If there is significant (>10%) missing data, data will be imputed by predictive mean matching. Subgroup analysis by type of incision (infraumbilical vs supraumbilical) will be performed.
Missing data and patterns will be assessed monthly by the data manager. Remedial measures, including retraining of staff, will be used as needed to minimize missing data. The investigators plan for an intention-to-treat analysis.
- Being tested
- Surgeon-administered transversus abdominis plane (TAP)
- Keywords
- randomized controlled trial, Transversus Abdominis Plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon-administered transversus abdominis plane (TAP)Procedure or surgery
Prior to fascial closure, the rectus muscle is gently elevated superiorly and the surgeon identifies its lateral border; the nerves that supply the anterior abdominal wall travel through the myofascial plane between internal oblique and transversus abdominis muscles, 2 fingerbreadths above the iliac crest. Access to this plane can easily be achieved by inserting a blunted needle through the parietal peritoneum; there is an appreciable loss of resistance ('one pop') and the correct plane is entered. After careful aspiration to ensure no vascular injury has occurred, 20 mL 0.25% bupivacaine or 20 mL of normal saline is injected slowly. The same procedure is repeated on the other side.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | Administration of 20ml of bupivacaine 0.25% on each side, for a total of 40ml. Receives: Procedure: Surgeon-administered transversus abdominis plane (TAP) |
| Saline | Placebo comparator | Administration on 20ml of normal saline on each side, for a total of 40ml. Receives: Procedure: Surgeon-administered transversus abdominis plane (TAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of opioid (in morphine equivalents) received in the postoperative period
Measured: 24 hours after surgery
Secondary outcomes (5)
Postoperative pain scores
Numerical Pain Rating Scale, from 0 to 10. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: at 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours after surgery
Postoperative nausea and vomiting rates
As defined by the Simplified Postoperative Nausea and Vomiting (PONV) impact scale
Measured: postoperative day 1
Time to flatus
In hours
Measured: During admission
Incidence of clinical ileus
as a surgeon's diagnosis of postoperative ileum, including diagnosis on abdominal x-ray, return to nothing-by-mouth status, or (re)insertion of a nasogastric tube.
Measured: During admission
Time to discharge from hospital
In hours
Measured: During admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Oct 2020
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Genital Neoplasm Malignant FemaleStudies of the same condition, open and under way.
- More trials run by McMaster 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be randomized to undergo a bilateral surgeon-administered Tranversus abdomens plane block with either 40ml of 0.25% bupivacaine or an equal volume of saline administered equally over both sides (placebo), prior to fascial closure. Forty patient will receive bupivacaine, and 40 patients will receive the placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurence Bernard, McMaster University
- Investigators
- Clare Reade, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202874
- Sponsor's protocol ID
- 8302
- Status last verified
- Nov 2021
- First submitted
- 16 Dec 2019
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
PubMed 30877144Rafi 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 11576144McDermott G, Korba E, Mata U, Jaigirdar M, Narayanan N, Boylan J, Conlon N. Should we stop doing blind transversus abdominis plane blocks? Br J Anaesth. 2012 Mar;108(3):499-502. doi: 10.1093/bja/aer422. Epub 2012 Jan 11.
PubMed 22236911Owen DJ, Harrod I, Ford J, Luckas M, Gudimetla V. The surgical transversus abdominis plane block--a novel approach for performing an established technique. BJOG. 2011 Jan;118(1):24-7. doi: 10.1111/j.1471-0528.2010.02779.x. Epub 2010 Nov 18.
PubMed 21083866Ravichandran NT, Sistla SC, Kundra P, Ali SM, Dhanapal B, Galidevara I. Laparoscopic-assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography-guided Transversus Abdominis Plane Block in Postlaparoscopic Cholecystectomy Pain Relief: Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):228-232. doi: 10.1097/SLE.0000000000000405.
PubMed 28472015Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.
PubMed 26397443Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
PubMed 21154380Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
PubMed 22632762Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
PubMed 21296242Chang H, Rimel BJ, Li AJ, Cass I, Karlan BY, Walsh C. Ultrasound guided transversus abdominis plane (TAP) block utilization in multimodal pain management after open gynecologic surgery. Gynecol Oncol Rep. 2018 Oct 15;26:75-77. doi: 10.1016/j.gore.2018.10.007. eCollection 2018 Nov.
PubMed 30364775Narasimhulu DM, Scharfman L, Minkoff H, George B, Homel P, Tyagaraj K. A randomized trial comparing surgeon-administered intraoperative transversus abdominis plane block with anesthesiologist-administered transcutaneous block. Int J Obstet Anesth. 2018 Aug;35:26-32. doi: 10.1016/j.ijoa.2018.04.007. Epub 2018 Apr 27.
PubMed 29914782Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
PubMed 22156268Kaye AD, Urman RD, Rappaport Y, Siddaiah H, Cornett EM, Belani K, Salinas OJ, Fox CJ. Multimodal analgesia as an essential part of enhanced recovery protocols in the ambulatory settings. J Anaesthesiol Clin Pharmacol. 2019 Apr;35(Suppl 1):S40-S45. doi: 10.4103/joacp.JOACP_51_18.
PubMed 31142958Bakkum-Gamez JN, Langstraat CL, Martin JR, Lemens MA, Weaver AL, Allensworth S, Dowdy SC, Cliby WA, Gostout BS, Podratz KC. Incidence of and risk factors for postoperative ileus in women undergoing primary staging and debulking for epithelial ovarian carcinoma. Gynecol Oncol. 2012 Jun;125(3):614-20. doi: 10.1016/j.ygyno.2012.02.027. Epub 2012 Feb 24.
PubMed 22370599Bernard L, Lavecchia M, Trepanier G, Mah S, Pokoradi A, McGinnis JM, Alyafi M, Glezerson B, Nguyen J, Carlson V, Helpman L, Elit L, Jimenez W, Eiriksson L, Reade CJ. A double-blinded, randomized trial comparing surgeon-administered transversus abdominis plane block with placebo after midline laparotomy in gynecologic oncology surgery. Am J Obstet Gynecol. 2023 May;228(5):553.e1-553.e8. doi: 10.1016/j.ajog.2023.02.010. Epub 2023 Feb 14.
PubMed 36791986
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Randomized Trial Comparing Surgeon-administered Transversus Abdominis Plane (TAP) Block With Placebo After Midline Laparotomy in Gynecologic Oncology
- ClinicalTrials.gov ID
- NCT04202874
- Acronym / sponsor ID
- 8302
- Keywords
- randomized controlled trial, Transversus Abdominis Plane block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. Administration by the surgeon of local anesthetics in the abdominal wall after surgery for a suspected gynaecological malignancy will be studied. Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be recruited. Half of these women will received a Transversus Abdominis Plane (TAP) block using local anesthetics, and half will receive a placebo (saline water). The primary outcome studied will be the total dose of opioid in morphine equivalents received in the postoperative period. The primary hypothesis is that surgeon-performed TAP blocks reduce the need for opioids after surgery. Secondary outcomes including postoperative pain scores, postoperative nausea and vomiting rates, time to flatus, incidence of clinical ileus and time to discharge from hospital will also be recorded.
Detailed description
Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. While ultrasound-guided Transversus Abdominis Plane (TAP) block has been shown to reduce postoperative opioid use, the time and expertise needed to perform it can be a barrier to administering the procedure. A surgeon-administered TAP block has been described, but has yet to be evaluated with a randomized controlled study in gynecology oncology patients undergoing a midline laparotomy. The investigators hypothesize that surgeon-administered TAP blocks may decrease total opioid use in the first 24 hours.
Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be recruited to undergo bilateral surgeon-administered TAP blocks with either 40ml of 0.25% bupivacaine or an equal volume of saline administered equally over both sides, prior to fascial closure. Exclusion criteria include inability to give informed consent, presence of contraindications or sensitivities to drugs specified in the protocol, pre-existing truncal sensory disturbance, history of chronic opioid use, infections at the injection site, significant adhesions on the anterior or lateral abdominal wall preventing access to the injection site, patients receiving neuraxial anesthesia (Epidural, Spinal) or local wound infiltration. The primary outcome studied will be the total dose of opioid in morphine equivalents received in the postoperative period. Secondary outcomes including postoperative pain scores, postoperative nausea and vomiting rates, time to flatus, incidence of clinical ileus and time to discharge from hospital will also be recorded.
Sample size calculation was based on a meta-analysis by Johns for use of TAP blocks in abdominal surgeries, that reported morphine equivalents mean at 24h as 20.6mg for the TAP group and 44.3mg for the control group (mean difference of 23mg in 24h), with a standard deviation of 14mg. To find a clinically significant decrease in opioid use of 20%, our primary outcome, with a 2-tailed analysis and power of 80%; the investigators would need 36 patients in each group. To account for potential dropouts and protocol violations, as well as secondary analyses, the investigators will recruit a total of 80 patients (40 in the TAP block group and 40 controls).
Differences in characteristics between treatment and control groups will be analysed using the chi-square test for dichotomous data, independent samples Student's t-test for parametric continuous variables, and Mann-Whitney U test for non-parametric continuous data. Test of normality will be performed using the Shapiro-Wilk test. If there is significant (>10%) missing data, data will be imputed by predictive mean matching. Subgroup analysis by type of incision (infraumbilical vs supraumbilical) will be performed.
Missing data and patterns will be assessed monthly by the data manager. Remedial measures, including retraining of staff, will be used as needed to minimize missing data. The investigators plan for an intention-to-treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Eighty women above the age of 18 and undergoing a midline laparotomy for a suspected gynecologic malignancy will be randomized to undergo a bilateral surgeon-administered Tranversus abdomens plane block with either 40ml of 0.25% bupivacaine or an equal volume of saline administered equally over both sides (placebo), prior to fascial closure. Forty patient will receive bupivacaine, and 40 patients will receive the placebo.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Procedure: Surgeon-administered transversus abdominis plane (TAP)Administration of 20ml of bupivacaine 0.25% on each side, for a total of 40ml. |
| Saline | Placebo comparator | Procedure: Surgeon-administered transversus abdominis plane (TAP)Administration on 20ml of normal saline on each side, for a total of 40ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 and above undergoing elective gynecologic oncology surgery for a suspected malignancy using a midline laparotomy incision.
Key exclusion criteria (8 listed)
- Patients unable to give informed consent
- Patients with contraindications or sensitivities to drugs specified in the protocol
- Pre-existing truncal sensory disturbance
- History of chronic opioid use (daily use > 3 months)
- Infections at the injection site
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 |
|---|---|---|
| Surgeon-administered transversus abdominis plane (TAP)Prior to fascial closure, the rectus muscle is gently elevated superiorly and the surgeon identifies its lateral border; the nerves that supply the anterior abdominal wall travel through the myofascial plane between internal oblique and transversus abdominis muscles, 2 fingerbreadths above the iliac crest. Access to this plane can easily be achieved by inserting a blunted needle through the parietal peritoneum; there is an appreciable loss of resistance ('one pop') and the correct plane is entered. After careful aspiration to ensure no vascular injury has occurred, 20 mL 0.25% bupivacaine or 20 mL of normal saline is injected slowly. The same procedure is repeated on the other side. | Procedure or surgery | Bupivacaine, Saline |
Primary outcome
Total dose of opioid (in morphine equivalents) received in the postoperative period
Time frame: 24 hours after surgery
5 secondary outcomes
Postoperative pain scores
Time frame: at 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours after surgery
Postoperative nausea and vomiting rates
Time frame: postoperative day 1
Time to flatus
Time frame: During admission
Incidence of clinical ileus
Time frame: During admission
Time to discharge from hospital
Time frame: During admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Background: PubMed 30877144Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
- 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.
- Background: PubMed 22236911McDermott G, Korba E, Mata U, Jaigirdar M, Narayanan N, Boylan J, Conlon N. Should we stop doing blind transversus abdominis plane blocks? Br J Anaesth. 2012 Mar;108(3):499-502. doi: 10.1093/bja/aer422. Epub 2012 Jan 11.
- Background: PubMed 21083866Owen DJ, Harrod I, Ford J, Luckas M, Gudimetla V. The surgical transversus abdominis plane block--a novel approach for performing an established technique. BJOG. 2011 Jan;118(1):24-7. doi: 10.1111/j.1471-0528.2010.02779.x. Epub 2010 Nov 18.
- Background: PubMed 28472015Ravichandran NT, Sistla SC, Kundra P, Ali SM, Dhanapal B, Galidevara I. Laparoscopic-assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography-guided Transversus Abdominis Plane Block in Postlaparoscopic Cholecystectomy Pain Relief: Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):228-232. doi: 10.1097/SLE.0000000000000405.
- Background: PubMed 26397443Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.
- Background: PubMed 21154380Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
- Background: PubMed 22632762Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
- Background: PubMed 21296242Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
- Background: PubMed 30364775Chang H, Rimel BJ, Li AJ, Cass I, Karlan BY, Walsh C. Ultrasound guided transversus abdominis plane (TAP) block utilization in multimodal pain management after open gynecologic surgery. Gynecol Oncol Rep. 2018 Oct 15;26:75-77. doi: 10.1016/j.gore.2018.10.007. eCollection 2018 Nov.
- Background: PubMed 29914782Narasimhulu DM, Scharfman L, Minkoff H, George B, Homel P, Tyagaraj K. A randomized trial comparing surgeon-administered intraoperative transversus abdominis plane block with anesthesiologist-administered transcutaneous block. Int J Obstet Anesth. 2018 Aug;35:26-32. doi: 10.1016/j.ijoa.2018.04.007. Epub 2018 Apr 27.
- Background: PubMed 22156268Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
- Individual participant dataSharing planned: No
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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.
Clare Reade, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgeon-administered transversus abdominis plane (TAP) in people with Genital Neoplasm Malignant Female and Surgical Procedure, Unspecified, run by McMaster University at 1 site in Canada.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Total dose of opioid (in morphine equivalents) received in the postoperative period (time frame: 24 hours after surgery). 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 NCT04202874, which also lists 15 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 17 Nov 2021.