Effect of Interscalene Nerve Block on Pain Control After Rotator Cuff Repair Surgery in the First Two Weeks-Interventional - Randomized controlled clinical trial
Effect of Interscalene Nerve Block on Pain Control After Rotator Cuff Repair Surgery in the First Two Weeks-Interventional - Randomized controlled clinical trial
Design
The current study is a single-blind clinical trial study that will be conducted in parallel. A total of 156 patients who are Candidate for open rotator cuff repair surgery patients will be included in the study. Eligible patients are randomly divided into two equal groups of A and B.
Settings and conduct
Patients who are Candidate for open rotator cuff repair surgery who visit Ghadir Mother and Child Hospital in Shiraz during the study will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using the random block method. This study will be conducted in a single-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with ASA grade I or II, patients between 18 and 65 years old, Candidate for open rotator cuff repair surgery and Tendon retraction measuring 2 centimeters or more. Exclusion criteria: allergy to the drugs used in the study, history of heart, respiratory, kidney diseases and addiction and pregnancy.
Intervention groups
Intervention Group: Patients in this group will receive an interscalene nerve block performed by an anesthesiologist prior to surgery. The block will be administered at the C6 vertebral level, targeting the anterior and middle scalene muscles under ultrasound guidance. A total of 20 mL of 0.5% bupivacaine will be injected. In addition to the nerve block, patients will receive 600 mg oral Gabapentin for two weeks postoperatively. anesthesia induction will be performed uniformly for all patients.
Control Group: Patients in this group will receive 600 mg oral Gabapentin for two weeks, Anesthesia induction will be conducted identically to that of the intervention group.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091117002723N6
Registration date:2025-06-20, 1404/03/30
Registration timing:prospective
Last update:2025-06-20, 1404/03/30
Update count:0
Registration date
2025-06-20, 1404/03/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
07112337636
Email address
hadavimr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-01, 1404/07/09
Expected recruitment end date
2026-05-01, 1405/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Interscalene Nerve Block on Pain Control After Rotator Cuff Repair Surgery in the First Two Weeks-Interventional - Randomized controlled clinical trial
Public title
Effect of Local Anesthetic Injection Near Shoulder Nerves on Pain Reduction for Cuff Repair Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients with ASA grade I or II (American Society of Anesthesiology classification)
Patients between 18 and 65 years old
Patients candidates for open rotator cuff repair surgery
Tendon retraction measuring 2 centimeters or more
Consent to participate in the study
Exclusion criteria:
Allergy to the drugs used in the study
Positive history of Heart, respiratory, kidney diseases and addiction
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
156
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups using block randomization. In this method, blocks of sizes 4, 6, and 8 are generated, each containing an equal number of patients allocated to groups A and B in alternating permutations. Patients are then randomly and equally distributed into the two groups based on these permuted blocks. The block sequences will be generated using the website www.sealedenvelope.com.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the operating room, The pain service anesthesiologist will perform only the nerve block and general anesthesia, while another independent anesthesiologist, blinded to randomization and anesthesia results, will only review and record the study variables. This study is single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2025-05-21, 1404/02/31
Ethics committee reference number
IR.SUMS.MED.REC.1404.137
Health conditions studied
1
Description of health condition studied
Rotator cuff tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
Pain
Timepoint
The pain score is recorded at 6 hours, 12 hours, 24 hours, 48 hours, 1 week, 10 days, and 2 weeks after surgery.
Method of measurement
Questionnaire and Numerical Pain Rating Scale (NRS)
Secondary outcomes
empty
Intervention groups
1
Description
Group 1(Intervention Group): Patients in this group will receive an interscalene nerve block performed by an anesthesiologist prior to surgery. The block will be administered at the C6 vertebral level, targeting the anterior and middle scalene muscles under ultrasound guidance. A total of 20 mL of 0.5% bupivacaine will be injected. The correct placement of the block will be confirmed by eliciting a brief contraction of the deltoid muscle using a nerve stimulator. In addition to the nerve block, patients will receive 600 mg oral Gabapentin for two weeks postoperatively. Upon arrival in the operating room, all patients will undergo comprehensive monitoring including pulse oximetry, electrocardiogram, and non-invasive blood pressure measurement. Following the nerve block, anesthesia induction will be performed uniformly for all patients.
Category
Treatment - Drugs
2
Description
Group 2(Control Group): Patients in this group will receive 600 mg oral Gabapentin for two weeks postoperatively without undergoing the interscalene nerve block. Similar to the intervention group, these patients will be monitored upon arrival in the operating room with pulse oximetry, electrocardiogram, and non-invasive blood pressure monitoring. Anesthesia induction will be conducted identically to that of the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Seyed Ali Hadavi
Street address
Ghadir Mother and Child Hospital, the beginning of Golshan town, above the Quran gate.
City
Shiraz
Province
Fars
Postal code
۷۱۴۴۹۹۵۳۷۷
Phone
+98 71 3227 9701
Fax
Email
Motherhosp@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
mohammadi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?