NCT02984865

The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Clinical Anesthesia

Status unknown NA Last updated 22 February 2018

What this trial tests

NA trial testing Sulfentanyl in Postoperative Nausea and Vomiting in 190 participants. Status unknown.

Timeline

20 December 2016

Primary endpoint
8 April 2018

1 May 2018

Quick facts

Lead sponsor	The First Affiliated Hospital of Anhui Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	190
Start date	20 December 2016
Primary completion	8 April 2018
Estimated completion	1 May 2018
Sites	1 location across China

Drugs / interventions tested

• Sulfentanyl — full drug profile →
• Nalbuphine — full drug profile →
• flubiprofen axetil
• rectus sheath block — full drug profile →

Conditions studied

• Postoperative Nausea and Vomiting — all drugs for Postoperative Nausea and Vomiting →
• Surgery — all drugs for Surgery →
• Anesthesia — all drugs for Anesthesia →
• Peritoneal Dialysis — all drugs for Peritoneal Dialysis →

Sponsor

The First Affiliated Hospital of Anhui Medical University

Who can join

18 and older, any sex, with Postoperative Nausea and Vomiting or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Mao Y, Cao Y, Mei B, Chen L, et al · · 2018 · cited 8× · PMID 29623143 · DOI 10.1155/2018/3637013