- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984865
The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Clinical Anesthesia
February 19, 2018 updated by: The First Affiliated Hospital of Anhui Medical University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Mao, postgraduate
- Phone Number: +86 18019951656
- Email: maoyu163flying@163.com
Study Contact Backup
- Name: Erwei Gu, bachelor
- Phone Number: +8613966663478
- Email: ay_guew_mz@163.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230032
- Recruiting
- The First Affiliated Hospital of Anhui Medical University
-
Contact:
- yu mao
- Phone Number: +86 18019951656
- Email: maoyu163flying@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group S
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 .
|
Other Names:
|
Experimental: group N1
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 .
|
|
Experimental: group N2
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 .
|
|
Experimental: group N3
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 .
|
|
Other: Group ESRD
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.
|
Transversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative nausea and vomiting
Time Frame: 48 hours after surgery
|
48 hours after surgery
|
verbal rating scale
Time Frame: during surgery
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative visual analogue scale of pain
Time Frame: 48 hours after surgery
|
48 hours after surgery
|
postoperative Ramsay of sedation
Time Frame: 48 hours after surgery
|
48 hours after surgery
|
first time for out of bed activity after surgery
Time Frame: 7days after surgery
|
7days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Xuesheng Liu, Doctor, The First Affiliated Hospital of Anhui Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kartalov 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.
- 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.
- Zeng 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.
- Huang 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.
- Akshat 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.
- Dai 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.
- Mao 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2016
Primary Completion (Anticipated)
April 8, 2018
Study Completion (Anticipated)
May 1, 2018
Study Registration Dates
First Submitted
November 30, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (Estimate)
December 7, 2016
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 19, 2018
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Nalbuphine
- Sufentanil
- Dsuvia
- Flurbiprofen
Other Study ID Numbers
- PJ-2016-09-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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