Effects of adding different doses of tramadol to bupivacaine solution for brachial plexus block on postoperative analgesia duration after arthroscopic shoulder surgery

Comparison of the efficacy of different doses of adjuvant perineural tramadol to 0.25% bupivacaine in prolongation of postoperative analgesia in arthroscopic shoulder surgeries under interscalene block

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140427017455N5

Enrollment

Registered

2019-03-25

Start date

2016-04-03

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post shoulder arthroscopic surgery analgesia duration. Opioids and related analgesics

Interventions

Intervention 1: Intervention group 1: Perineural injection of 0.25% bupivacaine and 1/200000 epinephrine with 100 mg tramadol in 15 milliliters volume in interscalene block. Intervention 2: Interventi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients candidate for Shoulder arthroscopic surgery Age 18 years or more ASA class I-II Intact cognition and contiousness

Exclusion criteria

Exclusion criteria: Patient refusal Contraindication for drug infiltration History of Allergic reactions to drug used in this study Contraindication for intrscalene block Contraindication for tramadol administration Opioid abuse history Pregnancy or baby breast feeding Chronic pain syndromes Any neurological problem in the same side upper limb History of epilepsy Body mass index 40 or higher

Design outcomes

Primary

Measure	Time frame
Postoperative pain scores at recovery. Timepoint: 10 minutes after patient's admission to recovery. Method of measurement: Visual Analogue Scale VAS.;Postoperative Pain Scores in the ward. Timepoint: 4, 8, 12, 18 and 24 hours post brachial plexus block. Method of measurement: Visual Analogue Scale VAS.;Time to maximum postoperative pain score. Timepoint: during the first postoperative 24-hours. Method of measurement: Visual Analogue Scale VAS.;Time to first rescue analgesic dose. Timepoint: During the first postoperative day. Method of measurement: First analgesic injection in ward based on patient's medical records.;Total administered opioid during the first postoperative 24-hours. Timepoint: during the first postoperative 24-hours. Method of measurement: total administered opioid from admission to ward to 24 hours post plexus block, based on medical records.;Total administered opioid in the recovery. Timepoint: During the recovery period. Method of measurement: total administered opioid during the recovery based on the patient's medical records.	—

Measure

Time frame

Postoperative pain scores at recovery. Timepoint: 10 minutes after patient's admission to recovery. Method of measurement: Visual Analogue Scale VAS.;Postoperative Pain Scores in the ward. Timepoint: 4, 8, 12, 18 and 24 hours post brachial plexus block. Method of measurement: Visual Analogue Scale VAS.;Time to maximum postoperative pain score. Timepoint: during the first postoperative 24-hours. Method of measurement: Visual Analogue Scale VAS.;Time to first rescue analgesic dose. Timepoint: During the first postoperative day. Method of measurement: First analgesic injection in ward based on patient's medical records.;Total administered opioid during the first postoperative 24-hours. Timepoint: during the first postoperative 24-hours. Method of measurement: total administered opioid from admission to ward to 24 hours post plexus block, based on medical records.;Total administered opioid in the recovery. Timepoint: During the recovery period. Method of measurement: total administered opioid during the recovery based on the patient's medical records.

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Secondary

Measure	Time frame
Nausea. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.;Vomiting. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.;Seizure. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.	—

Measure

Time frame

Nausea. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.;Vomiting. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.;Seizure. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Poya Zanjani

Tehran University of Medical Sciences

p_zanjani@yahoo.com+98 21 4415 4251

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026