CancerNCT07771712
Combined Pectoserratus and Superficial Cervical Plexus Block Versus Local Infiltration for Chemoport Implantation
A study testing Combined Pectoserratus Plane and Superficial Cervical Plexus Block, Local Infiltration Anesthesia with Bupivacaine 0.25% and Midazolam in people with Cancer and Perioperative Analgesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer, Perioperative Analgesia
- What is being tested?
- Combined Pectoserratus Plane and Superficial Cervical Plexus Block, Local Infiltration Anesthesia with Bupivacaine 0.25% and Midazolam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Dec 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Combined Pectoserratus Plane and Superficial Cervical Plexus Block, Local Infiltration Anesthesia with Bupivacaine 0.25%, Midazolam, Propofol
- Keywords
- chemoport implantation, additional opioid, local infiltration anesthesia, pectoserratus plane block, superficial cervical plexus block
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Pectoserratus Plane and Superficial Cervical Plexus BlockProcedure or surgery
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.
Local Infiltration Anesthesia with Bupivacaine 0.25%Procedure or surgery
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.
MidazolamDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Local Infiltration Anesthesia with Bupivacaine 0.25%; Drug: Midazolam; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From skin incision until completion of the chemoport implantation procedure, approximately 1-2 hours.
Secondary outcomes (4)
Postoperative Pain Intensity
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.
Measured: Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery
Additional Postoperative NSAID Requirement
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).
Measured: Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery
Patient Satisfaction
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
Measured: 24 hours after surgery
Procedure-Related Complications
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
Measured: From intervention until 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start23 Dec 2025
- Primary completion15 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771712
- Sponsor's protocol ID
- 2306285620
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07771712
- Acronym / sponsor ID
- 2306285620
- Conditions
- Cancer, Perioperative Analgesia
- Keywords
- chemoport implantation, additional opioid, local infiltration anesthesia, pectoserratus plane block, superficial cervical plexus block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block | Experimental | Procedure: Combined Pectoserratus Plane and Superficial Cervical Plexus Block, Drug: Midazolam, Drug: PropofolPlain 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. |
| Local Infiltration Anesthesia with Bupivacaine 0.25% | Active comparator | Procedure: Local Infiltration Anesthesia with Bupivacaine 0.25%, Drug: Midazolam, Drug: PropofolLocal 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Pectoserratus Plane and Superficial Cervical Plexus BlockAn 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 or surgery | Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block |
| 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. | Procedure or surgery | Local Infiltration Anesthesia with Bupivacaine 0.25% |
| MidazolamIntravenous 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 | Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block, Local Infiltration Anesthesia with Bupivacaine 0.25% |
| PropofolFollowing 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. | Drug | Combined Pectoserratus Plane Block and Superficial Cervical Plexus Block, Local Infiltration Anesthesia with Bupivacaine 0.25% |
Primary outcome
Intraoperative Additional Opioid Requirement
Time frame: 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).
4 secondary outcomes
Postoperative Pain Intensity
Time frame: Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery
Additional Postoperative NSAID Requirement
Time frame: Recovery room (0 hour), 2 hours, 6 hours, 24 hours after surgery
Patient Satisfaction
Time frame: 24 hours after surgery
Procedure-Related Complications
Time frame: From intervention until 24 hours postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Pectoserratus Plane and Superficial Cervical Plexus Block, Local Infiltration Anesthesia with Bupivacaine 0.25% and Midazolam in people with Cancer and Perioperative Analgesia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Additional Opioid Requirement (time frame: From skin incision until completion of the chemoport implantation procedure, approximately 1-2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.