Combined Pectoserratus and Superficial Cervical Plexus Block Versus Local Infiltration for Chemoport Implantation

NCT07771712 | Completed

• 1 other identifier: 2306285620
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Chemoport implantation is frequently performed in patients with cancer requiring long-term intravenous chemotherapy. Local infiltration anesthesia (LIA) remains the conventional anesthetic technique for this procedure. However, it often provides incomplete analgesia because sensory innervation of the anterior chest wall originates from multiple neural pathways. Consequently, patients may experience pain during the surgery, necessitating additional intraoperative opioid administration. Ultrasound-guided regional anesthesia has emerged as an effective alternative for chest wall procedures. The combined pectoserratus plane (PSP) block and superficial cervical plexus (SCP) block provides broader sensory coverage of the anterior chest wall involved in chemoport implantation. This combined technique has the potential to improve intraoperative analgesia, reduce opioid consumption, decrease postoperative pain, and enhance postoperative recovery while maintaining procedural safety. This prospective, single-blind, randomized controlled trial aims to compare the effectiveness of ultrasound-guided combined PSP and SCP block with conventional local infiltration anesthesia in adult cancer patients undergoing chemoport implantation under intravenous sedation. Participants will be randomly allocated in a 1:1 ratio to receive either combined PSP-SCP block or LIA. All participants will receive standardized sedation using dexmedetomidine. The primary outcome is intraoperative additional opioid requirement. Secondary outcomes included postoperative pain intensity, postoperative additional NSAID requirements, patient satisfaction, and procedure-related complications. The findings of this study are expected to provide evidence regarding the role of combined ultrasound-guided fascial plane blocks as an alternative anesthetic technique for chemoport implantation in cancer patients.

Conditions

Cancer; Perioperative Analgesia

Keywords

chemoport implantation; additional opioid; local infiltration anesthesia; pectoserratus plane block; superficial cervical plexus block

Outcome Measures

Primary Outcomes (1)

• Intraoperative Additional Opioid Requirement

  The requirement for additional intraoperative opioid analgesia during chemoport implantation procedure. All participants will undergo continuous intraoperative hemodynamic monitoring. An increase in mean arterial pressure (MAP) or heart rate (HR) of ≥20% from baseline occurring within 1 minute after a surgical stimulus, or patient movement suggestive of inadequate analgesia, will be considered indicative of intraoperative pain. In such cases, intravenous fentanyl 0.5 µg/kg body weight will be administered as rescue analgesia and repeated as necessary until adequate analgesia is achieved. The requirement for additional opioid analgesia and any conversion to general anesthesia will be recorded. The outcome will be recorded as whether additional opioid (fentanyl) was required (yes/no).

  From skin incision until completion of the chemoport implantation procedure, approximately 1-2 hours.

Secondary Outcomes (4)

• Postoperative Pain Intensity

  Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery

• Additional Postoperative NSAID Requirement

  Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery

• Patient Satisfaction

  24 hours after surgery

• Procedure-Related Complications

  From intervention until 24 hours postoperatively.

Study Arms (2)

Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block

EXPERIMENTAL

Plain 0.25% bupivacaine will be used as the local anesthetic, with a total volume of 15 mL, consisting of 12 mL for the PSP block and 3 mL for the SCP block. The maximum bupivacaine dose will not exceed 3 mg/kg body weight to minimize the risk of local anesthetic systemic toxicity (LAST). The blocks will be performed using an in-plane ultrasound-guided injection technique by Regional Anesthesia and Pain Medicine Specialty II MD, Faculty of Medicine Universitas Indonesia, who has been certified as competent. All participants will subsequently receive standardized intravenous sedation according to the study protocol.

Procedure: Combined Pectoserratus Plane and Superficial Cervical Plexus Block; Drug: Midazolam; Drug: Propofol

Local Infiltration Anesthesia with Bupivacaine 0.25%

ACTIVE COMPARATOR

Local anesthetic will be administered by direct infiltration into the subcutaneous tissue surrounding the surgical field to block nociceptive impulses from sensory nerve endings. The procedure will be performed by Regional Anesthesia and Pain Medicine Subspecialty MD, Faculty of Medicine Universitas Indonesia, who has been certified as competent. All participants will subsequently receive the same standardized intravenous sedation regimen according to the study protocol.

Procedure: Local Infiltration Anesthesia with Bupivacaine 0.25%; Drug: Midazolam; Drug: Propofol

Interventions

Combined Pectoserratus Plane and Superficial Cervical Plexus Block PROCEDURE

An ultrasound-guided combined regional block performed using the in-plane technique. Plain 0.25% bupivacaine will be administered with a total volume of 15 mL, consisting of 12 mL in the pectoserratus plane and 3 mL around the superficial cervical plexus. The total bupivacaine dose will not exceed 3 mg/kg body weight to reduce the risk of local anesthetic systemic toxicity (LAST). The procedure will be performed by Regional Anesthesia and Pain Medicine Subspecialty MD, Faculty of Medicine Universitas Indonesia, who is already competent.

Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block

Local Infiltration Anesthesia with Bupivacaine 0.25% PROCEDURE

Local infiltration anesthesia will be performed using plain 0.25% bupivacaine with a total volume of 15 mL, consisting of 3 mL at the needle insertion site, 5 mL at the surgical incision site, and 7 mL at the port-pocket area. The remaining 7 mL will be infiltrated subcutaneously into the port-pocket area, which measures approximately 3 cm2, using a fan-shaped injection technique.

Local Infiltration Anesthesia with Bupivacaine 0.25%

Midazolam DRUG

Intravenous midazolam will be administered as premedication at the beginning of the procedure at a dose of 0.4 mg/kg body weight, according to the study protocol.

Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block; Local Infiltration Anesthesia with Bupivacaine 0.25%

Propofol DRUG

Following intravenous midazolam premedication, propofol will be administered as an intravenous bolus at a dose of 1 mg/kg body weight, followed by a continuous intravenous infusion at 50 µg/kg body weight/minute until completion of the surgical procedure.

Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block; Local Infiltration Anesthesia with Bupivacaine 0.25%

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years.
• Diagnosed with cancer requiring elective chemoport implantation for long-term intravenous therapy.
• Classified as American Society of Anesthesiologists (ASA) Physical Status II or III.
• Scheduled to undergo chemoport implantation under intravenous sedation.
• Able to understand the study procedures and provide written informed consent.

You may not qualify if:

• Refusal to participate in the study.
• History of burns or infection at the chest wall in the planned injection area.
• Presence of a tumor involving the chest wall at the planned injection site.
• Known allergy or hypersensitivity to local anesthetic agents.
• Obesity, defined as a body mass index (BMI) \>30 kg/m².
• Severe coagulation disorders, defined as a platelet count \<50,000/µL or prolonged prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) greater than twice the upper limit of normal.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

MRCCC Siloam Hospitals Semanggi

Jakarta, DKI Jakarta, 12930, Indonesia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Midazolam; Propofol

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to treatment allocation throughout the study. Due to the nature of the interventions, the anesthesiologist performing the regional block or local infiltration anesthesia cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 18, 2026
• Study Start: December 23, 2025
• Primary Completion: June 15, 2026
• Study Completion: June 29, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)