The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05687981
Collaborator
(none)
90
2
12

Study Details

Study Description

Brief Summary

The present study will be undertaken to compare the postoperative analgesic effect of 0.25% bupivacaine and 0.5% bupivacaine for unilateral ilioinguinal and Iliohypogastric nerve block after open inguinal hernia repair.

Primary outcome:

The time to first request for rescue analgesia.

Secondary outcome:
  1. The post-operative pain in the form of NRS scores at rest & during movement at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure.

  2. The total 24 hour opioid consumption.

  3. The incidence of complication related to nerve block (urinary retention, hematoma, hypotension and arrhythmia).

  4. Patient satisfaction

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Postoperative pain is a common complication that may cause a neuroendocrine stress response, which is characterized by increased release of catabolic and immunosuppressive pituitary hormones and activation of the sympathetic nervous system. Excessive postoperative pain and the physiological stress response can influence postoperative outcomes, length of hospital stay and overall costs of hospital care Inguinal herniorrhaphy is a common outpatient surgical procedure with approximately 20 million operations performed worldwide annually.

Patients undergoing this procedure often experience moderate-to-severe pain, which can hinder post anesthesia care unit (PACU) discharge. While pain can be treated with opioid therapy, the literature supports that opioids may cause postoperative nausea, vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional block has been shown to decrease the previous complications.

There is an ongoing interest in developing regional anesthetic techniques that may reduce or eliminate the use of opioid analgesics after minor surgical procedures such as hernia repair.

Regional analgesia has found wide acceptance both by the patients and their treating physicians, and therefore, it is now an important part of multimodal analgesia techniques. Ilioinguinal/iliohypogastric nerve block(IINB),transversus abdominis plane (TAP) block, paravertebral and rectus sheath, have all been used for providing analgesia following abdominal surgeries .

The combined ilioinguinal and iliohypogastric nerve block (IINB) is a commonly used technique for blockade of the ilioinguinal/iliohypogastric (IIIH) nerves and has been shown to decrease pain after OIH as well as reduce opioid requirements.

Bupivacaine belongs to the amide family, and its structure is similar to that of lidocaine. Bupivacaine is a potent agent capable of producing prolonged anesthesia. Its long duration of action plus its tendency to provide more sensory than motor block has made it a popular drug for providing prolonged analgesia during the postoperative period.

We assume that the use of higher concentration of bupivacaine in ilioinguinal and iliohypogastric nerve block (IINB) might increase the efficacy of post-operative analgesia and patient satisfaction.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain.
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patients will receive 10 ml of 0.5% bupivacaine

A 2mg dexamethasone will be added

Drug: Bupivacaine
the use of higher concentration of bupivacaine in ilioinguinal and iliohypogastric nerve block (IINB) might increase the efficacy of postoperative analgesia

Active Comparator: Patients will receive 10 ml of 0.25% bupivacaine

A 2mg dexamethasone will be added

Drug: Dexamethasone
2 mg dexamethasone

Outcome Measures

Primary Outcome Measures

  1. The time to first request for rescue analgesia. [24 hours]

    if score is ≥ 3 analgesia needed

Secondary Outcome Measures

  1. The post-operative pain in the form of NRS. [at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure.]

  2. The total 24 hour opioid consumption [24 hours]

  3. The incidence of complication related to nerve block [48 hours]

    urinary retention, hematoma, hypotension and arrhythmia

  4. Patient satisfaction [48 hours]

    in the form of 4 point satisfaction questionnaire: where 1 would be satisfied, 2=neutral, 3=dissatisfied, and 4=extremely dissatisfied.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients between 21 and 60 years age with the American Society of Anesthesiologists' status I or II scheduled for elective primary open inguinal hernia repair
Exclusion Criteria:
  1. Patient refusal.

  2. Body mass index (BMI) >40 kg m2.

  3. The presence of skin infection at the injection site.

  4. Allergy to local anesthetic drugs.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

  • Study Director: Mohammad Abduallah, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mariam Jamal Elkasass, Dr, Tanta University
ClinicalTrials.gov Identifier:
NCT05687981
Other Study ID Numbers:
  • (IIIH) &(IINB) in pain control
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mariam Jamal Elkasass, Dr, Tanta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2023