Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07771712
NA

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

Sponsor: Indonesia University

View on ClinicalTrials.gov

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.

Official title: Effectiveness of Combined Pectoserratus Plane (PSP) and Superficial Cervical Plexus (SCP) Blocks Compared With Local Infiltration Anesthesia for Chemoport Implantation in Cancer Patients Undergoing Sedation

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-12-23

Completion Date

2026-06-29

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

PROCEDURE

Combined Pectoserratus Plane and Superficial Cervical Plexus Block

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.

PROCEDURE

Local Infiltration Anesthesia with Bupivacaine 0.25%

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.

DRUG

Midazolam

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.

DRUG

Propofol

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.

Locations (1)

MRCCC Siloam Hospitals Semanggi

Jakarta, DKI Jakarta, Indonesia