Cancer, Perioperative Analgesia
Conditions
Keywords
chemoport implantation, additional opioid, local infiltration anesthesia, pectoserratus plane block, superficial cervical plexus block
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.
Interventions
PROCEDURECombined 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.
PROCEDURELocal 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.
DRUGMidazolam
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.
DRUGPropofol
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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Additional Opioid Requirement | From skin incision until completion of the chemoport implantation procedure, approximately 1-2 hours. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 = no pain, 10 = worst imaginable pain. Higher scores indicate greater pain intensity. |
| Additional Postoperative NSAID Requirement | Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery | The requirement for additional postoperative nonsteroidal anti-inflammatory drug (NSAID) analgesia in addition to the scheduled postoperative analgesic regimen of oral paracetamol 500 mg four times daily. Participants who continue to report postoperative pain with a Numeric Rating Scale (NRS) score of ≥4 despite receiving scheduled paracetamol will be administered oral ibuprofen 400 mg as rescue analgesia. The administration of rescue NSAID analgesia will be recorded for each participant. The outcome will be recorded as whether additional NSAID analgesia was required (yes/no). |
| Patient Satisfaction | 24 hours after surgery | Patient satisfaction will be assessed using Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 is a validated patient-reported outcome measure evaluating physical comfort, emotional state, physical independence, psychological support, and pain. Total scores range from 0 to 150, with higher scores indicating better postoperative recovery and satisfaction |
| Procedure-Related Complications | From intervention until 24 hours postoperatively. | Incidence of complications associated with either combined blocks or local infiltration anesthesia. Complications include, but are not limited to: * Local anesthetic systemic toxicity (LAST) * Allergic reaction * Hematoma * Infection * Pneumothorax * Vascular puncture * Nerve injury * Phrenic nerve block * Recurrent laryngeal nerve block * Persistent sensory or motor deficit * Block failure requiring conversion to another anesthetic technique Measure: Incidence of adverse events |
Countries
Indonesia
Outcome results
None listed