Compare Continuous Gastrocnemius Plane Block With Intravenous Analgesia After Foot and Ankle Surgery

NCT05463809 | Unknown Phase 3

• 1 other identifier: Han Liu
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy and safety of a continuous gastrocnemius plane block for perioperative analgesia in patients undergoing foot and ankle surgery under elective general anesthesia.

Conditions

Foot Ankle Injuries

Keywords

nerve block; Continuous Gastrocnemius plane block

Outcome Measures

Primary Outcomes (1)

• Area under the pain intensity-time curve

  The smaller the area under the pain intensity-time curve, the better the nerve block effect

  Up to 48 hours postoperative

Secondary Outcomes (6)

• Percentage of subjects without remedial analgesics

  Up to 48 hours postoperative

• The cumulative amount of remedial analgesic drugs (oxycodone) used

  Up to 48 hours postoperative

• Number of remedial analgesia

  Up to 48 hours postoperative

• Number of effective patient controlled analgesia (PCA) compressions

  Up to 48 hours postoperative

• The proportion of the number of invalid presses to the total presses

  Up to 48 hours postoperative

Other Outcomes (6)

• The incidence of muscle strength and sensory abnormalities in the affected limb

  Up to 48 hours postoperative

• The incidence of adverse reactions, such as nausea, vomiting, and neurological complications

  Up to 48 hours postoperative

• First time to get out of bed

  Up to 48 hours postoperative

Study Arms (2)

Experimental group: Ropivacaine-controlled analgesia pump

EXPERIMENTAL

A single injection of 0.375% Ropivacaine 15 milliliters was given into the common peroneal nerve, medial sural cutaneous nerve, and lateral sural cutaneous nerve. Than，a catheter was placed in the gastrocnemius plane, and a 0.125% ropivacaine-controlled analgesic pump was applied.(The formulation was 0.125% ropivacaine at 300 milliliters, with a background dose of 3 milliliters/hours, a patient-controlled analgesia(PCA) dose of 8 milliliters, and a locking time of 25 minutes.）

Drug: Continuous Gastrocnemius plane block with ropivacaine

Control group: oxycodone-controlled analgesia pump

EXPERIMENTAL

No treatment was given preoperatively, and postoperative oxycodone patient-controlled intravenous analgesia(PCIA). After awakening, intravenous oxycodone was titrated according to numerical rating scale(NRS) score, providing analgesia without background dose of oxycodone patient-controlled intravenous analgesia(PCIA) pump (single dose 1 milligram, locking time 5 minutes, 14 hours limit 12 milligrams)

Drug: oxycodone

Interventions

Continuous Gastrocnemius plane block with ropivacaine DRUG

After extubation, the patient was routinely monitored for his vital signs.The nerve block operation was performed by the same doctor: let the patient take the lateral decubitus position, use the ultrasonic high-frequency array probe under the popliteal socket to scan the sciatic nerve, move the probe down to find the tibial nerve and the common peroneal nerve, and then a single injection of 0.375% Ropivacaine 15milliliters was given into the common peroneal nerve, medial sural cutaneous nerve, and lateral sural cutaneous nerve. Then avoid common peroneal nerve, use the indwelling needle (16GA 3.25 IN), and put the catheter after saline expansion.

Also known as: Automatic analgesic pump

Experimental group: Ropivacaine-controlled analgesia pump

oxycodone DRUG

The patient was revived and received intravenous oxycodone titration according to the numerical rating scale (NRS) score, and was treated with no background dose of oxycodone patient-controlled intravenous analgesia (PCIA) pump for analgesia.

Also known as: Automatic analgesic pump

Control group: oxycodone-controlled analgesia pump

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective foot and ankle surgery
• Patient informed consent was obtained
• Age 18 to 65 years Sex is not limited
• American Society of Anesthesiologists(ASA)Ⅰ\~Ⅲ level
• Body Mass Index(BMI)18\~28kg/m2

You may not qualify if:

• Puncture site infection
• Abnormal coagulation function
• Local anesthetic allergy
• Severe cardiopulmonary disease
• Liver and renal insufficiency
• Medical history of chronic pain
• Long-term use of sedative and analgesic drugs
• Communication disorders
• The operation time exceeded 3 hours

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Related Publications (8)

• Provenzano DA, Viscusi ER, Adams SB Jr, Kerner MB, Torjman MC, Abidi NA. Safety and efficacy of the popliteal fossa nerve block when utilized for foot and ankle surgery. Foot Ankle Int. 2002 May;23(5):394-9. doi: 10.1177/107110070202300504.

  PMID: 12043982 BACKGROUND

• Sun Li, Wei Jinju. Patient VAS was scored by ultrasound-guided continuous sciatic nerve block during foot surgery And the effect analysis of morphine dosage. Journal of Mathematical Medicine, 2019,32 (4): 523-524.

  BACKGROUND

• Anderson JG, Bohay DR, Maskill JD, Gadkari KP, Hearty TM, Braaksma W, Padley MA, Weaver KT. Complications After Popliteal Block for Foot and Ankle Surgery. Foot Ankle Int. 2015 Oct;36(10):1138-43. doi: 10.1177/1071100715589741. Epub 2015 Jun 24.

  PMID: 26109605 BACKGROUND

• Zhang Jinfang, Li Yimei. Ultrasound-guided continuous popliteal sciatic nerve block for postoperative analgesia in patients undergoing foot and ankle surgery. The World's Latest Medical Information Abstract, 2019,19 (68): 1-3.

  BACKGROUND

• Qiu Wen, Yu Bin. Randomized controlled study of continuous popliteal sciatic nerve block analgesia and intravenous analgesia after foot and ankle surgery. Journal of Tongji University (Medical edition), 2 018,39 (02): 99-102.

  BACKGROUND

• Gartke K, Portner O, Taljaard M. Neuropathic symptoms following continuous popliteal block after foot and ankle surgery. Foot Ankle Int. 2012 Apr;33(4):267-74. doi: 10.3113/FAI.2012.0267.

  PMID: 22735198 BACKGROUND

• Bai Shu order, should be dajun et al. descriptive anatomy. The People's Health Publishing House. 353-357.

  BACKGROUND

• Dong Guangyu, Huang Bingzhe, Zhang Hanyang, Chang Fei. Ankle joint block treatment. The Electronic Journal of Foot and Ankle Surgery. 2017, 4(3):59.

  BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Oxycodone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Jie Wei

CONTACT

18752113232; 961683175@qq.com

Liu Han

CONTACT

18951670163; han_cold.student@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 19, 2022
• Study Start: July 14, 2022
• Primary Completion: January 30, 2023
• Study Completion: June 1, 2024
• Last Updated: July 19, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share