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Outcome Measures

Primary Outcomes (1)

Postoperative Pain Intensity at 6 Hours
Pain intensity measured with the 11-point Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst imaginable pain), compared among the three groups.
6 hours after the end of surgery

Secondary Outcomes (6)

Postoperative Pain Intensity at 0 and 12 Hours
Immediately after the end of surgery (0 hours) and 12 hours after the end of surgery
Number of Participants Requiring Rescue Analgesia (Duration of Analgesia)
At 0, 6 and 12 hours after the end of surgery

Study Arms (3)

Group C: Ropivacaine 0.375%

ACTIVE COMPARATOR

Ultrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% (15 mL of ropivacaine 0.75% plus 15 mL of sterile water for injection), single perineural injection.

Drug: ropivacaine

Group L: Ropivacaine 0.375% + Lidocaine 1%

EXPERIMENTAL

Ultrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% plus lidocaine 1% (15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2%), single perineural injection.

Drug: lidocaine

Group E: Ropivacaine 0.375% + Lidocaine 1% With Epinephrine

EXPERIMENTAL

Interventions

ropivacaineDrug

Ropivacaine 112.5 mg (15 mL of 0.75%) administered perineurally in an ultrasound-guided supraclavicular brachial plexus block, diluted to a total volume of 30 mL.

Group C: Ropivacaine 0.375%

lidocaineDrug

Lidocaine 300 mg (15 mL of 2%) mixed with ropivacaine for perineural administration in the supraclavicular brachial plexus block (final lidocaine concentration 1%).

Group L: Ropivacaine 0.375% + Lidocaine 1%

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry

lidocaine with epinephrine

The registry names several treatments. This does not confirm that participants received them together or that they form a single product.

View registry record

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineLidocaineEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic Chemicals

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Single masking (outcomes assessor). The allocation sequence was generated by the principal investigator, and the sealed envelopes and study syringes were kept by the thesis investigator, who opened each envelope immediately before the block. Outcomes (latency, motor block by the Bromage scale, postoperative pain by the 0-10 numeric rating scale, duration of analgesia and need for rescue analgesia) were assessed and recorded by the attending anesthesiologists and anesthesiology residents in charge of each participant, who were assigned to operating rooms by a daily schedule set by the department of anesthesiology independently of the study and were unaware of group allocation. Participants were not formally masked, and the investigators were aware of the allocation.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation. Adults aged 18 to 59 years scheduled for upper limb orthopedic or trauma surgery under ultrasound-guided supraclavicular brachial plexus block were randomly assigned to one of three local anesthetic mixtures, all in a total volume of 30 mL: ropivacaine 0.375% alone (Group C, active comparator), ropivacaine 0.375% plus lidocaine 1% (Group L), or ropivacaine 0.375% plus lidocaine 1% with epinephrine 2.5 micrograms/mL (Group E). The principal investigator generated the allocation sequence in Excel for folios 1 to 138; allocation was concealed in sealed envelopes identified by folio number and opened immediately before the block. Each participant received a single block and was followed until 12 hours after surgery. Sedation and multimodal analgesia were standardized across groups.

Sponsor Type

OTHER GOV

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Anesthesiologist, Principal Investigator

Ropivacaine Alone Versus Ropivacaine Plus Lidocaine With or Without Epinephrine for Supraclavicular Brachial Plexus Block in Upper Limb Orthopedic Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Group C: Ropivacaine 0.375%

Group L: Ropivacaine 0.375% + Lidocaine 1%

Group E: Ropivacaine 0.375% + Lidocaine 1% With Epinephrine

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Group C: Ropivacaine 0.375%

Group L: Ropivacaine 0.375% + Lidocaine 1%

Group E: Ropivacaine 0.375% + Lidocaine 1% With Epinephrine

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations