Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery

NCT ID: NCT04306159

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2021-08-16

Brief Summary

General anesthesia combined subcostal transversus abdominis plane (TAP)or rectus sheath block (RSB)can significantly reduce the use of opiates in minimally invasive surgery.However, similar reduction was not observed in open abdominal surgery during perioperative period.Therefore, the investigators should try to improve the blocking methods to reduce the side effects of a large number of opiates. Based on the range and its analgesic effect of various nerve block is obviously related to the injection site of local anesthetics, this randomized controlled study hypothesized that modified RSB under the guidance of surgical incision may be more effective in inhibiting the harmful stimulation of surgery.

Detailed Description

For abdominal cancer surgery with midline incision, subcostal transversus abdominis plane or rectus sheath block combined with general anesthesia was more effective in reducing pain scores and opioid consumption compared with general anesthesia alone. However, there was no statistically significant difference in supplementary fentanyl during operation. Besides adequate pain relief around incisions, blunting visceral traction response has also an important role in hemodynamic stability.With the evidences for a potential mechanism for the antinociceptive effects of propofol on visceral nociception and dexmedetomidine combined with oxycodone can provide good visceral analgesia, the investigators supposed that visceral nociception was well suppressed by adequate antinociceptive drugs. The propofol combination with dexmedetomidine may had significant effect on the reduction of the sympathoadrenergic tone with decrease of blood pressure and heart rate.

Conditions

Opioid Consumption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

General anesthesia

Basal blood pressure and heart rate were recorded after midazolam administration of 0.02 mg/kg. Anesthesia was induced with sufentanil 0.4 μg/kg and propofol 2-2.5 mg/kg, IV route. An IV bolus of cisatracurium 0.1 mg/kg IV was given to facilitate tracheal intubation. Anesthesia was maintained with propofol 4-6 mg/kg/h combined dexmedetomidine 0.2 μg/kg/h(after 0.2 μg/kg/h loading dose within 15min)by bispectral index (BIS) 40-60 and additional bolus doses of remifentanil 0.2-0.5 μg/kg/min to keep arterial pressure values around 20% below baseline values. Sufentanil 0.1-0.2 μg/kg and flurbiprofen 100mg was administrated once the abdomen was closed, then a patient controlled analgesia pump was used. No RSB was performed.

Group Type: SHAM_COMPARATOR

General anesthesia

Intervention Type: OTHER

Traditional general anesthesia management

Subcostal TAP combined with General anesthesia

After induction, TAP was performed. The transversus abdominis plane is imaged with the ultrasound probe obliquely on the upper abdominal wall, along the subcostal margin near the midline.The needle tip was advanced to the desired position where 20 mL 0.375%ropivacaine(Dexamethasone 5mg was added)were injected.The technique is repeated on the opposite side. Anesthesia method and management was same as general anesthesia group.

Group Type: EXPERIMENTAL

Subcostal TAP

Intervention Type: PROCEDURE

Subcostal transversus abdominis plane block

Modified RSB combined with General anesthesia

After induction, Modified RSB was performed based on midline incision-guided. The rectus muscle is imaged with the ultrasound probe in a transverse orientation below the xiphisternum and above the umbilicus.The needle tip was advanced to the two desired position where 10 mL ropivacaine 0.375% were injected causing hydrodissection of the rectus muscle away from the posterior rectus sheath.The technique is repeated on the opposite side.Anesthesia method and management was same as general anesthesia group.

Group Type: EXPERIMENTAL

Modified RSB

Intervention Type: PROCEDURE

Rectus Sheath Block under the guidance of surgical incision

Interventions

Subcostal TAP

Subcostal transversus abdominis plane block

Intervention Type: PROCEDURE

Modified RSB

Rectus Sheath Block under the guidance of surgical incision

Intervention Type: PROCEDURE

General anesthesia

Traditional general anesthesia management

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18-85 years
• Anesthesiologists (ASA) risk classification I to IV
• Scheduled to undergo midline incision of upper abdomen (From xiphoid to navel )

Exclusion Criteria

• Patient refusal
• Any contraindications to regional techniques (allergy to local anesthetics, infection around the site of the block, and coagulation disorder)
• History of analgesics dependence
• Any difficulty with communication
• Allergy to the study drugs
• Heat rate < 50 beats/minutes or II-III Atrioventricular block
• Previous open surgery
• Previous definite history of malignant tumor
• Who had an estimated intraoperative blood loss of more than 500 mL

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guanghong Xu, MD.PHD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Anhui Medical University

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

201911

Identifier Type: -

Identifier Source: org_study_id