Postoperative Nausea and VomitingNCT02984865
The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Clinical Anesthesia
A study testing Sulfentanyl, Nalbuphine and flubiprofen axetil in people with Postoperative Nausea and Vomiting and Surgery, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
Peritoneal dialysis (PD) catheter placement surgery for patients with end-stage renal disease (ESRD) can be performed under peripheral nerve block. This study assessed the ability of ultrasound guided left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Surgery, Anesthesia
- What is being tested?
- Sulfentanyl, Nalbuphine and flubiprofen axetil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2016to 1 May 2018
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ESRD scheduled for PD catheter placement belonging to American Society of Anesthesiologists (ASA) Grade 2 to 4 were included in the study.
- Elderly patients who were over 65 years old ,undergoing open gastrointestinal surgeries were included in the study.
Who cannot join
- Exclusion criteria included patients refusal, history of abdominal surgery, coagulation disorders, allergy to local anesthetic and localized infection on the injection site.
- The exclusion criteria were patient refusal, respiratory insufficiency,cardiac insufficiency,liver or kidney dysfunction，history of brain disease,local anesthetic allergy, dysfunction of blood coagulation，hemodynamic instability, history of any chronic pain, and history of chronic opioid use.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230032
yu mao, +86 18019951656, maoyu163flying@163.com
About this study
Official title: The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Peritoneal Dialysis Catheter Placement and Analgesia Based on Transversus Abdominis Plane Block Combined With κ Receptor Agonist and NSAID(Non-steroidal Anti-inflammatory Drug ) Following Open Gastrointestinal Surgery
Peritoneal dialysis (PD) catheter placement surgery for patients with end-stage renal disease (ESRD) can be performed under peripheral nerve block. This study assessed the ability of ultrasound guided left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery. Also, surgeries are common surgeries performed in elderly patients throughout the world. Although there is an increasing trend towards laparoscopic surgeries, open procedures continue to remain common therapeutic modalities especially in the developing countries. Pain is reported more commonly in patients undergoing open procedures than laparoscopic procedures. Postoperative pain and tissue injury associated with surgery initiated a systemic stress response which has neuroendocrine, immunological, and haematological responses. Opioids are an important modality of postoperative pain management. They blunt the neuroendocrine stress response to pain. However, they are associated with several adverse effects like respiratory depression, nausea, vomiting , pruritus, constipation, urinary retension, bradycardia and hypotension. Transversus abdominis plane block（TAPB）is a relative novel procedure in which local anesthetic agents are injected into the anatomic plane between the internal oblique and the transversus abdominis muscle. It allows a significantly prolonged duration of analgesia during the early postoperative stage in abdominal surgery. This regional anesthesia technique provides analgesia to the skin, muscles of the anterior abdominal wall and parietal peritoneum in order to decrease the incision-related pain. Thus, it reduces postoperative opiate requirements and opioids-related side effects (nausea, vomiting, delayed resumption of intestinal transit, drowsiness, respiratory depression, urine retention). Nalbuphine, being mu antagonist an kappa agonist, has a ceiling effect in its respiratory depression. Many studies have reported that incidence of adverse effects like pruritus and PONV is lower with nalbuphine in comparison with morphine. The purpose of this study is to compare the analgesic efficacy and side effect profile of sulfentanyl with nalbuphine in elderly patients undergoing open gastrointestinal surgeries.
Read the detailed description
This study will be conducted in the department of Anesthesiology of the first affiliated hospital of Anhui Medical University, Hefei city, Anhui province, China. In our part 1, we are plan to observe 30 patients with ESRD who underwent PD catheter placement using left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from our center. The TAP and RS blocks will be respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity will be evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction will be qualified by a categorical scale. In part 2, the sample size was calculated based on the previous data in our hospital using sulfentanyl and flurbiprofen axetil as the opioid analgesic. The rate of postoperative nausea and vomiting(PONV) after surgery was 35%. Keeping the power of the study as 80% and 5% alpha error with the number of pairwise comparisons as 6, a total sample size of 124 was needed to identify a difference of 0.25 in the rate of PONV. Each group would require at least 31 patients. To allow for dropouts, the investigator decided to include 40 patients in each group. Elderly patients who were over 65 years old, undergoing open gastrointestinal surgeries were included in the study. Patients were divided into four groups, that is group S, group N1, group N2 and group N3, based on the drawing of an opaque sealed envelop.The anesthesiologists managing the intraoperative and postoperative courses as well as patients were blinded to the group which they belonged.The drug solution to be used intraoperatively and postoperatively as PCA (patient-controlled analgesia) was prepared by an assistant. Patients were interviewed before surgery and informed written consent was taken form each patient. Patients were shown a VAS (visual analogue score) of 0-10 for pain with 0 being no pain and 10 being worst pain ever felt, and instructed upon the use of PCA (patient-controlled analgesia) before surgery. Patients were subjected to monitoring of ECG, pulse oximetry and invasive blood pressure. 20ml combination of 0.5% ropivacaine and 10mg dexamethasone was injected bilaterally between the internal oblique and transverse abdominis muscles using sonography. All groups received standard general anesthesia.
- Conditions
- Postoperative Nausea and Vomiting, Surgery, Anesthesia, Peritoneal Dialysis, Rectus Sheath Block
- Being tested
- Sulfentanyl, Nalbuphine, flubiprofen axetil, rectus sheath block
- Keywords
- transversus plane block, opioid, nalbuphine, gastrointestinal surgery, elderly patient, rectus sheath block, Peritoneal dialysis
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfentanylDrug
Also called sulfentanil
NalbuphineDrug
flubiprofen axetilDrug
rectus sheath blockProcedure or surgery
Transversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD
| Study group | Role | What they receive |
|---|---|---|
| group S | Active comparator | Patients were attach with PCA containing 100ml combination of sulfentanyl 2.5ug/kg and flubiprofen axetil 100mg after receiving the loading dose of sulfentanyl 5 ug and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . Receives: Drug: Sulfentanyl; Drug: flubiprofen axetil |
| group N1 | Experimental | Patients were attach with PCA containing 100ml combination of nalbuphine 1.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . Receives: Drug: Nalbuphine; Drug: flubiprofen axetil |
| group N2 | Experimental | Patients were attach with PCA containing 100ml combination of nalbuphine 2mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . Receives: Drug: Nalbuphine; Drug: flubiprofen axetil |
| group N3 | Experimental | Patients were attach with PCA containing 100ml combination of nalbuphine 2.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . Receives: Drug: Nalbuphine; Drug: flubiprofen axetil |
| Group ESRD | Other | 30 patients with ESRD who underwent PD catheter placement using left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from our center. The TAP and RS blocks were respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity was evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction was qualified by a categorical scale. Receives: Procedure: rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
Measured: 48 hours after surgery
verbal rating scale
Measured: during surgery
Secondary outcomes (3)
postoperative visual analogue scale of pain
Measured: 48 hours after surgery
postoperative Ramsay of sedation
Measured: 48 hours after surgery
first time for out of bed activity after surgery
Measured: 7days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start20 Dec 2016
- Primary completion8 Apr 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Model description
- The first group was designed to observe the advantage of transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery, which is independent from other 4 groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuesheng Liu, Doctor, Study director, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984865
- Sponsor's protocol ID
- PJ-2016-09-05
- Status last verified
- Jun 2017
- First submitted
- 30 Nov 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.
PubMed 24993433Zeng Z, Lu J, Shu C, Chen Y, Guo T, Wu QP, Yao SL, Yin P. A comparision of nalbuphine with morphine for analgesic effects and safety : meta-analysis of randomized controlled trials. Sci Rep. 2015 Jun 3;5:10927. doi: 10.1038/srep10927.
PubMed 26039709Kartalov A, Jankulovski N, Kuzmanovska B, Zdravkovska M, Shosholcheva M, Spirovska T, Petrusheva AP, Tolevska M, Srceva M, Durnev V, Jota G, Selmani R, Sivevski A. Effect of Adding Dexamethasone as a Ropivacaine Adjuvant in Ultrasound-Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):35-41. doi: 10.1515/prilozi-2015-0076.
PubMed 27442394Huang D, Ma X, Zhou D. [Effects of postoperative analgesia of ultrasound-guided transversus abdominis plane block in hemicolectomy patients]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1623-6. Chinese.
PubMed 25152283Akshat S, Ramachandran R, Rewari V, Chandralekha, Trikha A, Sinha R. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial. Pain Res Treat. 2014;2014:727952. doi: 10.1155/2014/727952. Epub 2014 Apr 14.
PubMed 24834352Dai W, Lu Y, Liu J, Tang L, Mei B, Liu X. Ultrasound-guided left lateral transversus abdominis plane block combined with rectus sheath block in peritoneal dialysis catheter placement. J Anesth. 2018 Aug;32(4):645-648. doi: 10.1007/s00540-018-2528-2. Epub 2018 Jul 5.
PubMed 29978298Mao Y, Cao Y, Mei B, Chen L, Liu X, Zhang Z, Gu E. Efficacy of Nalbuphine with Flurbiprofen on Multimodal Analgesia with Transverse Abdominis Plane Block in Elderly Patients Undergoing Open Gastrointestinal Surgery: A Randomized, Controlled, Double-Blinded Trial. Pain Res Manag. 2018 Jan 28;2018:3637013. doi: 10.1155/2018/3637013. eCollection 2018.
PubMed 29623143
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Peritoneal Dialysis Catheter Placement and Analgesia Based on Transversus Abdominis Plane Block Combined With κ Receptor Agonist and NSAID(Non-steroidal Anti-inflammatory Drug ) Following Open Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT02984865
- Acronym / sponsor ID
- PJ-2016-09-05
- Conditions
- Postoperative Nausea and Vomiting, Surgery, Anesthesia, Peritoneal Dialysis, Rectus Sheath Block
- Keywords
- transversus plane block, opioid, nalbuphine, gastrointestinal surgery, elderly patient, rectus sheath block, Peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 8 Apr 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- 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.
Peritoneal dialysis (PD) catheter placement surgery for patients with end-stage renal disease (ESRD) can be performed under peripheral nerve block. This study assessed the ability of ultrasound guided left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery. Also, surgeries are common surgeries performed in elderly patients throughout the world. Although there is an increasing trend towards laparoscopic surgeries, open procedures continue to remain common therapeutic modalities especially in the developing countries. Pain is reported more commonly in patients undergoing open procedures than laparoscopic procedures. Postoperative pain and tissue injury associated with surgery initiated a systemic stress response which has neuroendocrine, immunological, and haematological responses. Opioids are an important modality of postoperative pain management. They blunt the neuroendocrine stress response to pain. However, they are associated with several adverse effects like respiratory depression, nausea, vomiting , pruritus, constipation, urinary retension, bradycardia and hypotension. Transversus abdominis plane block（TAPB）is a relative novel procedure in which local anesthetic agents are injected into the anatomic plane between the internal oblique and the transversus abdominis muscle. It allows a significantly prolonged duration of analgesia during the early postoperative stage in abdominal surgery. This regional anesthesia technique provides analgesia to the skin, muscles of the anterior abdominal wall and parietal peritoneum in order to decrease the incision-related pain. Thus, it reduces postoperative opiate requirements and opioids-related side effects (nausea, vomiting, delayed resumption of intestinal transit, drowsiness, respiratory depression, urine retention). Nalbuphine, being mu antagonist an kappa agonist, has a ceiling effect in its respiratory depression. Many studies have reported that incidence of adverse effects like pruritus and PONV is lower with nalbuphine in comparison with morphine. The purpose of this study is to compare the analgesic efficacy and side effect profile of sulfentanyl with nalbuphine in elderly patients undergoing open gastrointestinal surgeries.
Detailed description
This study will be conducted in the department of Anesthesiology of the first affiliated hospital of Anhui Medical University, Hefei city, Anhui province, China. In our part 1, we are plan to observe 30 patients with ESRD who underwent PD catheter placement using left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from our center. The TAP and RS blocks will be respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity will be evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction will be qualified by a categorical scale. In part 2, the sample size was calculated based on the previous data in our hospital using sulfentanyl and flurbiprofen axetil as the opioid analgesic. The rate of postoperative nausea and vomiting(PONV) after surgery was 35%. Keeping the power of the study as 80% and 5% alpha error with the number of pairwise comparisons as 6, a total sample size of 124 was needed to identify a difference of 0.25 in the rate of PONV. Each group would require at least 31 patients. To allow for dropouts, the investigator decided to include 40 patients in each group. Elderly patients who were over 65 years old, undergoing open gastrointestinal surgeries were included in the study. Patients were divided into four groups, that is group S, group N1, group N2 and group N3, based on the drawing of an opaque sealed envelop.The anesthesiologists managing the intraoperative and postoperative courses as well as patients were blinded to the group which they belonged.The drug solution to be used intraoperatively and postoperatively as PCA (patient-controlled analgesia) was prepared by an assistant. Patients were interviewed before surgery and informed written consent was taken form each patient. Patients were shown a VAS (visual analogue score) of 0-10 for pain with 0 being no pain and 10 being worst pain ever felt, and instructed upon the use of PCA (patient-controlled analgesia) before surgery. Patients were subjected to monitoring of ECG, pulse oximetry and invasive blood pressure. 20ml combination of 0.5% ropivacaine and 10mg dexamethasone was injected bilaterally between the internal oblique and transverse abdominis muscles using sonography. All groups received standard general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
- Model description
- The first group was designed to observe the advantage of transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery, which is independent from other 4 groups.
| Arm | Type | Receives |
|---|---|---|
| group S | Active comparator | Drug: Sulfentanyl, Drug: flubiprofen axetilPatients were attach with PCA containing 100ml combination of sulfentanyl 2.5ug/kg and flubiprofen axetil 100mg after receiving the loading dose of sulfentanyl 5 ug and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . |
| group N1 | Experimental | Drug: Nalbuphine, Drug: flubiprofen axetilPatients were attach with PCA containing 100ml combination of nalbuphine 1.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . |
| group N2 | Experimental | Drug: Nalbuphine, Drug: flubiprofen axetilPatients were attach with PCA containing 100ml combination of nalbuphine 2mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . |
| group N3 | Experimental | Drug: Nalbuphine, Drug: flubiprofen axetilPatients were attach with PCA containing 100ml combination of nalbuphine 2.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation . |
| Group ESRD | Other | Procedure: rectus sheath block30 patients with ESRD who underwent PD catheter placement using left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from our center. The TAP and RS blocks were respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity was evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction was qualified by a categorical scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with ESRD scheduled for PD catheter placement belonging to American Society of Anesthesiologists (ASA) Grade 2 to 4 were included in the study.
- Elderly patients who were over 65 years old ,undergoing open gastrointestinal surgeries were included in the study.
Key exclusion criteria (2 listed)
- Exclusion criteria included patients refusal, history of abdominal surgery, coagulation disorders, allergy to local anesthetic and localized infection on the injection site.
- The exclusion criteria were patient refusal, respiratory insufficiency,cardiac insufficiency,liver or kidney dysfunction，history of brain disease,local anesthetic allergy, dysfunction of blood coagulation，hemodynamic instability, history of any chronic pain, and history of chronic opioid use.
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 |
|---|---|---|
| SulfentanylAlso: sulfentanil | Drug | group S |
| Nalbuphine | Drug | group N1, group N2, group N3 |
| flubiprofen axetil | Drug | group N1, group N2, group N3, group S |
| rectus sheath blockTransversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD | Procedure or surgery | Group ESRD |
Primary outcome
postoperative nausea and vomiting
Time frame: 48 hours after surgery
verbal rating scale
Time frame: during surgery
3 secondary outcomes
postoperative visual analogue scale of pain
Time frame: 48 hours after surgery
postoperative Ramsay of sedation
Time frame: 48 hours after surgery
first time for out of bed activity after surgery
Time frame: 7days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Background: PubMed 24993433Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.
- Background: PubMed 26039709Zeng Z, Lu J, Shu C, Chen Y, Guo T, Wu QP, Yao SL, Yin P. A comparision of nalbuphine with morphine for analgesic effects and safety : meta-analysis of randomized controlled trials. Sci Rep. 2015 Jun 3;5:10927. doi: 10.1038/srep10927.
- Background: PubMed 27442394Kartalov A, Jankulovski N, Kuzmanovska B, Zdravkovska M, Shosholcheva M, Spirovska T, Petrusheva AP, Tolevska M, Srceva M, Durnev V, Jota G, Selmani R, Sivevski A. Effect of Adding Dexamethasone as a Ropivacaine Adjuvant in Ultrasound-Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):35-41. doi: 10.1515/prilozi-2015-0076.
- Background: PubMed 25152283Huang D, Ma X, Zhou D. [Effects of postoperative analgesia of ultrasound-guided transversus abdominis plane block in hemicolectomy patients]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1623-6. Chinese.
- Background: PubMed 24834352Akshat S, Ramachandran R, Rewari V, Chandralekha, Trikha A, Sinha R. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial. Pain Res Treat. 2014;2014:727952. doi: 10.1155/2014/727952. Epub 2014 Apr 14.
- Derived from this study: PubMed 29978298Dai W, Lu Y, Liu J, Tang L, Mei B, Liu X. Ultrasound-guided left lateral transversus abdominis plane block combined with rectus sheath block in peritoneal dialysis catheter placement. J Anesth. 2018 Aug;32(4):645-648. doi: 10.1007/s00540-018-2528-2. Epub 2018 Jul 5.
- Derived from this study: PubMed 29623143Mao Y, Cao Y, Mei B, Chen L, Liu X, Zhang Z, Gu E. Efficacy of Nalbuphine with Flurbiprofen on Multimodal Analgesia with Transverse Abdominis Plane Block in Elderly Patients Undergoing Open Gastrointestinal Surgery: A Randomized, Controlled, Double-Blinded Trial. Pain Res Manag. 2018 Jan 28;2018:3637013. doi: 10.1155/2018/3637013. eCollection 2018.
- 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.
Xuesheng Liu, Doctor study director
The First Affiliated Hospital of Anhui Medical 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 Sulfentanyl, Nalbuphine and flubiprofen axetil in people with Postoperative Nausea and Vomiting and Surgery, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
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 2 inclusion and 2 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 22 Feb 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Mao, postgraduate (+86 18019951656, maoyu163flying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea and vomiting (time frame: 48 hours after surgery). The study lists 2 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 NCT02984865, which also lists 7 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 22 Feb 2018.