Clinical trial NCT05259345: Comparison of SE-TAP, M-TAPA, and Rectus Sheath Block in Abdominal Surgeries
Official title: Comparison of Subcostal Exterior Semilunaris Transverses Abdomens, Modified Thoracoabdominal Nerves Block Through Perichondrial Approach, and Rectus Sheath Block in Patients Undergoing Major Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: fascial plane blocks
postoperative pain
opioid consumption
quality of recovery
abdominal surgery
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomised controlled study is to compare the effects of three different fascial plane block \[subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)\] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.

Detailed description: In last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (TAP) block and rectus sheath block (RSB) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. Furthermore, the number of newly defined block techniques is daily increasing like M-TAPA and SE-TAP block.

The rectus sheath block (RSB) is an old technique that suite midline incisions and provides analgesia for somatic pain. The local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. It has been suggested that both anterior and lateral branches of the T5-T12 thoracoabdominal nerves are blockade in M-TAPA and SE-TAP blocks. So, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. However, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge.

Patients and Methods: This is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. While the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. At the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral SE-TAP block in Group S, bilateral RSB in Group R, and bilateral M-TAPA block in Group M will be performed under ultrasound guidance. Patient controlled analgesia with intravenous morphine will be started at the recovery room. Postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology physical classification I-III
* Scheduled for elective laparotomy with a midline incision

Exclusion Criteria:

* Not agree to participate in the study
* Have mental status disorders
* Inability to communicate
* Known bleeding and/or coagulation disorders
* Infection at injection site
* Chronic opioid intake

Primary outcomes:
measure: Quality of Recovery
timeFrame: At postoperative 24th hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
measure: Opioid consumption
timeFrame: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Faculty of Medicine
Study officials:
affiliation: Eskisehir Osmangazi University Faculty of Medicine
name: Gulay Erdogan Kayhan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakshi SG, Mapari A, Shylasree TS. REctus Sheath block for postoperative analgesia in gynecological ONcology Surgery (RESONS): a randomized-controlled trial. Can J Anaesth. 2016 Dec;63(12):1335-1344. doi: 10.1007/s12630-016-0732-9. Epub 2016 Sep 14.