A Novel Analgesic Method for Postoperative Pain Relief After Cesarean Section: Intraoperative Superior Hypogastric Block

NCT03897764 | Completed Phase 4 DMC

• 1 other identifier: 101/5.5.2017
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section is the most common inpatient surgical procedure in the United States with 1.3 million cesarean deliveries performed in 2015. Cesarean section frequency is increasing rapidly in worldwide, especially in middle and high income countries. Postoperative pain is an expected outcome for patients following surgical procedures. Inadequate pain relief is still a common problem among hospitalized patients. Cesarean section ranked ninth for pain severity among 179 different surgical procedures. Multimodal pain therapy has been suggested for postoperative pain management after cesarean delivery. The most commonly used modalities are systemic administration of opioids, either by intramuscular injection or IV by patient-controlled analgesia, and neuraxial injection of opioid as part of a regional anesthetic for cesarean delivery. These techniques have specific advantages and disadvantages. Superior hypogastric plexus blockade (SHB) has been shown an effective method for pain relıef after gynecologic procedures, it has been shown that SHP can be easily performed intraoperatively during hysterectomy procedure In this study, we aimed to investigate the efficacy of SHB performed intraoperatively for postoperative pain relief after cesarean section. To our knowledge, this is the first study to use SHB intraoperatively for pain relief after cesarean section in the literature.

Conditions

Postoperative Pain

Keywords

cesarean section; postoperative pain; superior hypogastric block

Outcome Measures

Primary Outcomes (1)

• Pain scores on rest and on movement at 24 th hour after surgery

  Postoperative pain assessed by the 10 cm visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable

  up to 24 hours

Secondary Outcomes (5)

• Pain scores on rest and on movement at 2,6 and 48 th hour after surgery

  Up to 48 hours

• Opioid or NSAID requirement after surgery

  Up to 48 hours

• Return of gastrointestinal function

  Up to 48 hours

• Rate of nausea and vomiting

  Up to 48 hours

• length of surgery

  Up to 1 hour

Study Arms (2)

Superior Hypogastric Block group

EXPERIMENTAL

The group which superior hypogastric block performed intraoperatively

Procedure: Intraoperative superior hypogastric plexus block

placebo controlled group

PLACEBO COMPARATOR

The group which placebo used

Procedure: Intraoperative superior hypogastric plexus block

Interventions

Intraoperative superior hypogastric plexus block PROCEDURE

SHP is situated anterior to L5-S1 vertebral bodies, caudal to the bifurcation of the aorta. An injection of 20 ml of bupivacaine 2,5 mg/ml or saline 9 mg/ml was done retroperitoneally in the area.

Superior Hypogastric Block group; placebo controlled group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only pregnant women scheduled for cesarean operation eligible fot he study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Term singleton pregnant women between ages 18 to 40 with no previous history of cesarean section or abdominal surgery were scheduled for elective cesarean operation under general anaesthesia. Only ASA 1-2 patients were included to the study.

You may not qualify if:

• We excluded patients with suspected or manifest bleeding disturbances, chronic pelvic pain, allergy to NSAID's or opioids, atopia, bronchial asthma, diabetes mellitus, the presence of liver or kidney diseases, abuse of drugs or alcohol, and patients with pregnancy-induced hypertension or preeclampsia. The patients underwent emergency cesarean section were also excluded from the study.

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University Faculty of Medicine

Istanbul, 34844, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Berna Haliloglu Peker, Prof. Dr

  Maltepe University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were randomly allocated in two groups. The allocation sequence was generated by a random number table, and group allocation was concealed in sealed, opaque envelopes that were not opened until operation. During the operation the envelope was opened by a nurse outside the operating theatre. The nurse prepared a blind syringe with the study drug, which was then transferred to a sterile bowl in the operating room and injected. Both bupivacaine and saline are colourless and not possible to identify the solution by its visual appearance, or by smell. The envelope was then sealed again and not opened until the study was concluded. The patients, anesthesiologists, and nurses providing postoperative care were blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Berna Haliloglu Peker

Model Details: prospective double-blinded randomized placebo controlled study

Study Record Dates

• First Submitted: March 23, 2019
• First Posted: April 1, 2019
• Study Start: January 2, 2019
• Primary Completion: February 20, 2019
• Study Completion: March 20, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)